When most kids were running around their middle schools full of energy and excitement, Taylor Gautney was quietly fighting an invisible battle. In sixth grade, while his classmates joined extracurriculars and laughed through lunch breaks, Taylor was barely making it through the day. Many afternoons were spent passed out on the couch after going the entire day without eating. One day, after skipping lunch again, he collapsed on his way back to class. That moment changed everything.
At first, doctors suspected celiac disease. He was placed on a gluten-free diet after an initial endoscopy, but nothing improved. For years, the mystery lingered—until a more thorough examination revealed the real culprit: Crohn’s disease. A new diagnosis, a new treatment—Humira—and a new outlook on life began to take shape.
Now in remission and attending Arizona State University (ASU), Taylor has transformed his story from one of struggles to one of strength. But it wasn’t always easy. This week on Lights, Camera, Crohn’s a firsthand look at what it was like to be diagnosed with IBD at such a young age and how his first year of college went living across the country from his family.
“Just Keep Fighting”
Looking back, Taylor wishes he could tell his younger self one thing: “Just keep fighting and enjoying the positives in life.” Being diagnosed with a chronic illness at age 11 felt like a devastating detour. He admits that it changed the way he viewed the world and himself. “I started to think of every aspect of life as negative,” he recalls. But over time, Taylor learned to embrace small joys, and most importantly, to appreciate the unwavering support of his family.
Taylor’s mom, Anna, says, “It’s crucial to advocate for your child and speak up for them if medications are not working. It is also important to showcase to your child that you are in this with them, help them find a community, such as the Crohn’s and Colitis Foundation. This way, they can meet people who have what they have and formulate a sense of belonging.”
Holding On Through the Hard Days
Taylor wants young people diagnosed with IBD to know that while the patient experience is incredibly challenging—often filled with procedures and surgery, flare days, and quiet battles with your own body, it doesn’t define who you are. “People can’t see the diagnosis from the outside, they see your personality and exterior self,” he says. “Just be yourself, let people come to you and support you, especially during a rough time like an IBD diagnosis.”
The Power of Family
Taylor credits his parents for being the steady foundation beneath his feet throughout the rollercoaster of diagnoses and treatments. “My mom has been my rock,” he says. She’s been by his side at almost every appointment and has researched tirelessly to understand Crohn’s. Taylor’s dad always makes time to show Taylor the world with family trips and unshakable support. “They have given everything to me and made my life so much easier after the diagnosis.”
Life at ASU with IBD
Taylor’s transition to college life came with its own set of hurdles, including logistical nightmares like getting his medication delivered to campus. But he’s found his rhythm. “It’s definitely not as hard as I thought it would be,” he says. One surprising blessing? His roommate. “He also had a medical condition that required shots, pills, and daily maintenance,” Taylor says. Their shared experiences helped them form an instant bond, even leading to grocery trips for IBD-friendly dorm snacks.
Taylor’s professors and friends have also shown deep compassion. He remembers an English professor who read about his condition in a personal essay and went out of her way to learn more about Crohn’s. “She made me feel really special and seen,” he says. His friends check in on him, make sure he’s got his injections, and understand when he needs to sit out from social events. “I thank my friends at ASU for their understanding and empathy.”
A Voice for the Voiceless
Studying sports journalism, Taylor dreams of becoming a play-by-play broadcaster for Major League Baseball—ideally for the Atlanta Braves. But his passion extends beyond sports. He wants to use his voice to make an impact and tell meaningful stories. One of the most pivotal moments in his life came when he was asked to be the Pediatric Honored Hero for the Crohn’s & Colitis Foundation’s Birmingham walk. “That one event gave me confidence to speak in public and really sparked my love for communication,” he says.
Now connected with the Arizona-New Mexico chapter of the Foundation, Taylor is committed to giving back. His mission? To reach kids and teens who are newly diagnosed and remind them they are not alone.
Final thoughts
Taylor and I connected after he was doing research for a college project and reached out to interview me about my patient experience and advocacy work. During our initial Zoom interview, I was so blown away by his positive attitude and how he takes on life with IBD. I asked him during the call if I could have the honor of sharing his story. While there are male patient advocates—we need more who are willing to share their story.
Taylor is wise beyond his years, so articulate, genuine, and kind. The sky is truly the limit when it comes to his future. If anything, living with Crohn’s disease since age 11 has helped show him all he’s capable of despite his disease.
You can connect with Taylor by following him on Instagram: @t.gautney or by emailing him: tgautney@asu.edu.
It feels like a punch to the gut. Even though you’re anticipating it, the experience is not easy for anyone. For patients with inflammatory bowel disease (IBD), stability is everything. Whether living with Crohn’s disease or ulcerative colitis, finding a medication that keeps symptoms under control is often the result of years of trial and error. So, when insurance companies or healthcare systems mandate a switch from a familiar biologic like Humira to a biosimilar such as Hyrimoz or Amjevita, the decision can feel sudden, confusing, and unsettling. As of right now (May 2025) there are 22 FDA-approved biosimilars on the market for infliximab (Remicade), adalimumab (Humira), and Ustekinumab (Stelara) with many more coming down the pipeline.
It’s easy for providers to rely solely on the science that says it should be a “seamless,” effortless transition for patients and caregivers—but that’s not always the case, nor is it ever a guarantee. This week on Lights, Camera, Crohn’s we hear from more than 30 patients who have lived this reality. While many people seem to do well clinically, it’s imperative that we also discuss the mental and emotional toll this forced non-medical switch takes on people with chronic, debilitating illnesses and their caregivers. This blog aims to demystify biosimilars, highlight the emotional and clinical complexity of switching therapies, and provide guidance for healthcare providers and patients navigating this challenging transition.
As someone who was forced off my Humira after being on it for 16 years and put on Hyrimoz, I empathize with how complicated this is for patients. Not only was I petrified to switch—but I had a God-awful experience that resulted in going from deep remission to dealing with an adverse response for two months of my life, while trying to be a mom to three young kids.
I don’t take this subject lightly and frankly; I don’t care who I piss off by sharing this patient experience transparently. I angered some donors from a Pharmacy Benefit Manager (PBM) when I spoke on stage in front of a large crowd last fall genuinely thanking my IBD nurse who went to bat for me countless times to help me win my appeal to get back on Humira—this isn’t about profit, it’s about patients. We don’t owe anyone an apology for being uncertain about being told we need to switch our heavy-duty drug therapy not by a doctor, but by someone working in corporate America.
Biosimilars are not generics
First things first, I must clear the air on this. Almost every direct message I receive from patients refers to biosimilars as “generics” …and that’s a common misconception that needs to be done away with.
Unlike generic drugs, which have identical active components, biosimilars are comparable but not identical to their originator drugs. According to the US-FDA, a biosimilar is a biological product that is potent, pure, and safe and that is “highly similar to and has no clinically meaningful differences from an existing US-FDA-approved reference product”. In other words, biosimilars are equivalent to the reference biologics regarding safety and efficacy.
When you hear the terms “originator” or “reference” biologics—that means Infliximab (Remicade), adalimumab (Humira), and Ustekinumab (Stelara). There are many other biologics of course, but so far, these three biologics have biosimilars approved by the FDA. You can familiarize with their names that I’ve listed below so if you see one listed in a letter it’s not foreign to you.
Infliximab Biosimilars:
Inflectra (infliximab-dyyb)
Renflexis (infliximab-abda)
Avsola (infliximab-axxq)
Ixifi (infliximab-qbtx)
Zymfentra (infliximab-dyyb)
Adalimumab Biosimilars:
Amjevita (adalimumab-atto)
Cyltezo (adalimumab-adbm)
Abrilada (adalimumab-afzb)
Hadlima (adalimumab-bwwd)
Hulio (adalimumab-fkjp)
Hyrimoz (adalimumab-adaz)
Idacio (adalimumab-aacf)
Yuflyma (adalimumab-aaty)
Yusimry (adalimumab-aqvh)
Simlandi (adalimumab-ryvk)
Ustekinumab Biosimilars:
Wezlana (ustekinumab-auub)
Selarsdi (ustekinumab-aekn)
Otulfi (ustekinumab-aauz)
Imuldosa (ustekinumab-srlf)
Yesintek (ustekinumab-kfce)
Pyzchiva (ustekinumab-ttwe)
Steqeyma (ustekinumab-stba)
Important note: While these biosimilars have received FDA approval, the availability of some may be subject to patent litigation settlements or market launch agreements, potentially delaying their commercial availability.
Let’s look at the real-life numbers
While working on this article, I ran several polls on Instagram asking the IBD community about their personal experiences. Some of the findings surprised me:
Have you received a letter saying you have to switch? Of the 265 respondents, 64% of patients said “yes”, and 36% said “no”.
Did you appeal before switching to a biosimilar? Out of 200 responses, 33% responded “yes” and 67% responded “no”.
For those who switched was the transition seamless—or did you notice an uptick in symptoms? Of the 140 responses, 51% had a seamless transition and 49% noticed an uptick in symptoms. This right here speaks volumes.
If you responded poorly to your biosimilar and your GI appealed insurance, what was the outcome of the appeal? Out of 75 responses—38% of patients were denied, 32% were put back on the originator drug (biologic), and for 30% after multiple appeals they finally won and returned on their biologic.
Let’s hear directly from patients
Bre: “I was taken off Humira after the New Year and placed on Simlandi for my ulcerative colitis. I was nervous as I had just come out of a two-year flare and had finally found a drug that worked and even though I was reassured that this was as good as Humira, I still had my doubts. Thankfully, I have had a positive experience and have remained in remission since starting Simlandi in January. I hope this story helps others feel less afraid of the potential outcomes when they get the dreaded non-coverage letters.”
Kyrsten: “Back in April I was forced off Stelara to the biosimilar, Yesintek. I went into it with an open mind because my Crohn’s has been in remission for about a year and a half. Unfortunately, I am now experiencing more symptoms that I’m documenting and oral manifestations of Crohn’s and need to see an oral medicine doctor now.”
Stefanie: “I’ve had to switch biosimilars twice at this point, this second time, while I was pregnant. I’m doing just fine!”
Alexandra: “I was first afraid of Humira, then I grew into being afraid of not having it; so, when my insurance mandated the switch to Hyrimoz late last summer, I was so worried (as all are/were)! In September, I was starting to feel some symptoms pop in, so we did all the tests, which indicated that I was still in clinical remission. Thankfully, I am doing ok now with no issues.”
Christina: “It was first recommended to me by my GI a couple of months after diagnosis in 2021 to start on biologics, since the oral medications had stopped working for me. We collectively decided the best option for me would be Remicade, however when it was brought to my insurance company, they immediately denied it. Insurance said it wasn’t their “preferred method” and wanted me to try and fail Humira first. When my GI tried to get the Humira approved, my insurance company ended up denying that, too, and this time, their excuse was it “wasn’t medically necessary.” It took my GI a couple of months to get a biologic approved and I almost ended up back in the hospital as a result.”
After receiving her first injection, Christina ended up developing an allergic reaction and had to be switched to something else. After another month of fighting insurance, Christina’s GI was able to get Remicade approved.
Christina goes on to say, “I did very well on that for about a year, until my body developed antibodies, and I had to switch once again. I then started Entyvio infusions which I have been on ever since, and so far, I’ve been doing well on it.”
Audrey: “I was forced to switch from Remicade to Inflectra a few years ago due to insurance coverage. My job at the time was horribly stressful and very time-consuming and getting the news then about my medication no longer being covered and that my next infusion was delayed because of this change over the phone from my infusion clinic was terrible. I remember sitting in the workplace cafeteria when my phone rang, and I burst into tears and was pleading with the pharmacist that gave me the news prior to receiving the letter.”
At this point, Audrey was receiving Remicade every seven weeks. With the delay and having to wait for Inflectra to be shipped, she was pushed out an extra week.
“The thing that made me so angry, was that I had already received my Remicade shipment, the nurses just weren’t allowed to mix and dispense it because of the insurance change. I refused to toss that Remicade dose until the vials expired, since I knew how costly it was. I called so many charity pharmacies for low-income folks to see if they could take the vials and since its temperature controlled, they couldn’t. Such a waste,” said Audrey.
Thankfully, Audrey tells me she hasn’t had any issues with the switch, and she’s stayed in remission—even during and after her first pregnancy. But she says the stress and frustration that occurred impacted her mental health at the time.
Kelly: “I just got the letter. Been on Stelara since 2017. I also take it every four weeks, even though the recommended dose is every eight weeks. I get my insurance through my husband and our insurance turns over on 6/31/25. The new policy begins July 1st. I’m really concerned and honestly don’t want to deal with this.”
Sandi: “I was forced to change from Remicade that had me in remission for several years to Inflectra and the outcome was not good. I had multiple Crohn’s flares a month, which was not happening when I was in remission. My GI appealed and after a year, insurance started to cover my Remicade again. Since getting back on Remicade, I’m in deep remission, again.”
Britt: “I was diagnosed with Crohn’s in 2011 at the same time I was diagnosed with Primary Sclerosing Cholangitis (PSC), a rare liver disease. I was on Remicade and was switched to Avsola. For a while, I was quite skeptical, but we stayed the course. I had some ups and downs with my health, but I was just told I am in histological remission by my GI! After five years of struggles to find the right medication, my health finally seems to have aligned. I also take 6mp to reduce antibody development to the Avsola.
Danielle: “I went into my pregnancy in remission and my first and second trimesters were lovely. About halfway through my pregnancy, insurance decided it was the right time to swap my medications. Two weeks following that change, I was already struggling. I ended up finishing my pregnancy on two different rounds of methotrexate and iron infusions. I had a scheduled C-section at 39 weeks, and I think my care team hoped that my body was just struggling balancing pregnancy and Crohn’s…that was not the case at all.”
Danielle says she tried two more Inflectra infusions after her daughter was born and saw no improvement. She required a round of prednisone and that didn’t help either. She was then switched to Humira injections every two weeks and they seemed to work wonderfully and she started to feel better.
“Then my insurance threatened to switch me to a Humira biosimilar, but Humira failed me right when that was supposed to happen, so I was transitioned to Entyvio. For six months I saw no improvement on Entyvio…more prednisone and still NO improvement. Finally when my daughter was 14 months old (so over a year and a half of feeling like absolute garbage and having no energy) I got bowel resection surgery and switched to Stelara.”
Danielle went on to say she’s been in remission since December 2021, and she still wonders if switching to the Remicade biosimilar caused all this to happen.
“I truly feel like that change took part of the joy of pregnancy away from me and also took a lot of special time away from my daughter the first 14 months of her life. I spent her second Christmas in the hospital unable to see her for two weeks. I was on so many pain medications for so long before the surgery that I don’t remember her first birthday. I lost a lot simply because someone was trying to cut costs and making decisions they are not educated about.”
Brooke: “I was on Remicade for 15 years, then I was forced to switch to Inflectra. I was incredibly stressed and tried to appeal but lost that battle. I’ve now been on Inflectra for 3 years and I am doing well! I still hate that we are forced to change when something is going well. The amount of stress, anxiety, and time I spent fighting the insurance company took a toll on me.”
Brooke went on to say that she got pregnant and had a daughter while on Inflectra. Her GI and OB had no concerns with the biosimilar during pregnancy.
Maya: “At the beginning of March, I was told by my insurance that Stelara will no longer be covered and that I would be put on Yesintek. I’ve only gotten one dose of it so far, but I very much empathize with all the emotions that come with getting the letter. So far, I haven’t noticed any additional symptoms or changes in how I feel. I’m hoping Yesintek works for me and that I continue to feel ok!”
Maria: “I live in Sweden where Humira is covered by the State since no private insurance is needed, the last year though I was recommended from doctors to switch to a biosimilar. So, in autumn of last year, I decided to try Hyrimoz. I noticed no difference in the first three months, but after that, I saw an increase in symptoms, especially for my rheumatoid arthritis. My doctor recommended that I take the injection weekly instead of biweekly, but that didn’t help at all. Since I haven’t developed any antibodies, my doctor switched me back to Humira and I felt the difference right away.”
Sadly, Maria recently got the news that Humira will no longer be covered in Sweden starting in August, so she will either have to pay out of pocket or find another medication.
“You can imagine how that feels. Humira has been my trusted friend since 2008, managing my Crohn’s and RA so well. Hard to think of life without it,” Maria said with a tearful emoji.
Kenzie: “I’ve been on two different biosimilars of Remicade. Inflectra was seamless—no issues. Then, a few years later, I got new insurance, and they made me switch to Avsola, which I had an allergic reaction to. No allergic reactions to Remicade or Inflectra, after being on them for more than six years. Now I’m on Cimzia injections (not a biosimilar) because it’s safe for nursing and that just seemed like the better option for me right now. I’ve only been on Cimzia for 10 weeks, but so far, my Crohn’s and RA seem slightly better.”
Audrey: “I switched to a biosimilar (Inflectra) in January 2022. I got pregnant in June 2024 and delivered a healthy baby boy this March. No disease issues thus far.”
Tara: “I was on a biosimilar when I conceived and throughout my entire pregnancy. I’m on Hulio and everything went well. I stayed in remission throughout the pregnancy and postpartum.”
Amanda: “I was able to conceive and am currently pregnant on a biosimilar. Everything is going great, thankfully I was on Humira for about six years and then got the dreaded letter to switch. I went on Hyrimoz at the end of last summer and was on it for five months prior to getting pregnant.”
Lauren: “I conceived and was pregnant with my now 3-week-old all while on Inflectra. I stayed in remission the whole time.”
Katie: “I was able to conceive while on Avsola, a biosimilar to Remicade. I haven’t experienced any issues related to pregnancy. I did develop some antibodies though and had to escalate my dose while pregnant. I also take premeds of Solumedrol and Benadryl before every infusion now. I got hives during the Avsola infusion while I was pregnant.”
Erica: “My doctor wouldn’t appeal it. I was put on Amjevita. Thank goodness and knock on alllll the wood…it’s been going well. I haven’t noticed any difference in symptoms. It’s been a little over a month, so I pray it stays that way.”
Jessica: “Conceived and pregnant on Inflectra infusions. I just had a healthy baby girl one month ago, and I’m now breastfeeding. No problems at all.”
Marla: “I switched to Hyrimoz while pregnant and I did not notice a change. However, I will say I’ve been in remission since getting pregnant with my first child and I don’t always take my medicine on time, so I don’t know if the transition was seamless because the medicine is truly fine or if it’s because my body just does well while I’m pregnant and breastfeeding (which I basically have been the past four years having three babies). I will say it’s an ABSOLUTE nightmare trying to get my medication each month. Constant bills I’m having to fight and constant new prescriptions and prior auths from my doctor for the SAME medication. It’s literally unreal. I blame that on CVS Specialty pharmacy.”
Amanda: “While I was pregnant, my OB appealed because insurance would no longer cover my Delzicol for ulcerative colitis. I won but was only allowed to stay on it until I delivered, then I had to switch to a generic mesalamine.”
Christine: “Pregnancy is what got me a temporary appeal. Once the baby was born, I had to switch, but it was peace of mind not having to make the transition during pregnancy. I was anxious that it was just a regular infusion, there wasn’t a loading dose or a slow rate or anything. They just infused the Inflectra the same way they infused the Infliximab. About two years after making the switch, I had to go from every 7 weeks to every 6, but I will never know if it was due to the biosimilar or if after 10 years on a biologic/biosimilar, my body just needed the drug at more regular intervals.”
Danielle: “I was pregnant (in remission), and my GI decided that was the correct time to switch me to Inflectra from Remicade…it did NOT go well.”
Jordyn: “I found out I was pregnant around the same time I had my first biosimilar infusion. I went through my whole pregnancy on the biosimilar and only noticed an uptick in symptoms around 10ish weeks, which a course of steroid foam resolved. Postpartum is when I noticed the return of symptoms the most. After 2 or 3 infusions (I get them every 4 weeks) with no improvement, I asked for an appeal, and it was granted for me to go back on Remicade.”
Natalie: “I got pregnant the month after switching to Avsola. I made the switch November 2022 to the biosimilar and found out I was pregnant December 29th. Pregnancy went fine, delivered in August 2023, all my problems started in February 2024. I went back on Remicade at that point because my GI suspected I had serum sickness for months on end, and to this day, they still aren’t sure if the serum sickness initiated my problem of Crohn’s attacking my joints.”
Angie: “We were told we would have to switch, but the doctor office contacted them, and they will be covering me at least until September for Humira…then we will renew the prescription and hope that it will be covered, again.”
Jasmine: “I’m on Avsola (biosimilar for Remicade) and I wasn’t trying to get pregnant, but did, and had a perfectly healthy pregnancy.”
Allie: “My specialists appealed saying I was going through fertility treatments and then insurance approved my Remicade for another year.”
Malea: “I got my insurance letter recently and have been meaning to reach out as I remember your Humira nightmare. I have not appealed yet, partly because my GI office is incredibly dysfunctional and hard to get ahold of. I am on Stelara, which is the first thing to have kept my Crohn’s in remission and they want me to switch to Selarsdi, which I can not find any patient experiences/anecdotal evidence about.”
Georgia: “I was on Humira last summer when Accredo tried to switch me to a biosimilar without notification. I had a letter saying that my Humira was still covered. I worked with my GI who told me they are seeing this a lot and if the person doesn’t push back, they just switch them to a biosimilar. But, if the person pushes back, the GI calls Accredo with a code (DW1 Brand Medically Necessary) to block it. That’s what I did, and they therefore had to send me my Humira since my insurance was still covering it. I want to let others know in case they have a prior authorization from their insurance saying they will cover Humira, despite the pharmacy trying to switch them!”
Jessica: “I so appreciate you talking about this. For my daughter, I went to refill her Humira, and insurance said the doctor allowed the switch. I asked the doctor, and they said no…it’s insurance. I had to use one of my daughter’s biosimilar pens while mine was being shipped, and I noticed more pain and burning. I advocated for my daughter to be on brand name only and they approved the request. When it came to my biologic, my letter had the same wording and once again it was insurance, not my doctor.”
Jessica’s GI said despite her being in remission for so long, she would need to try the biosimilar, then if any symptoms occurred then they could fight for return to the originator drug.
The Emotional Toll of a Forced Switch
For many patients, switching medications, especially after long-term remission, can trigger anxiety, mistrust, and a profound sense of vulnerability. Here are a few of the emotional and psychological responses patients may face:
Fear of Flare-ups: Patients often fear that a new medication might not work as well, risking disease recurrence and potentially hospitalization. So many of us have been relying on our biologic as a crutch for several years if not decades, it’s worrisome when you find a medication that works and have to change simply because insurance decides it’s necessary.
Loss of Control: Being told to switch due to non-medical reasons (like insurance mandates) can feel disempowering.
Medical Trauma: Those who’ve experienced years of instability before finding an effective treatment may associate medication changes with setbacks and suffering.
Distrust in the System: Patients may feel like financial decisions are being prioritized over their health and well-being.
How to Comfort and Support Patients Through the Transition
Healthcare providers and care teams play a critical role in guiding patients through these difficult changes. Here are some key strategies to help:
Educate With Compassion: Clearly explain what biosimilars are, how they’re tested, and what the current evidence says about their safety and effectiveness in IBD. Emphasize that switching is based on clinical research and real-world data, not just cost. Have discussions about biosimilars with patients in clinic even if they haven’t received a letter in the mail yet so they are prepared.
Validate Their Concerns: Avoid minimizing fears. Instead, acknowledge them openly. Saying, “I understand why you’re anxious about this” creates space for honest discussion and trust-building.
Advocate When Necessary: If a patient is stable and deeply concerned about switching, advocate on their behalf. Some payers allow exemptions if a provider makes a strong clinical case for staying on the original biologic. It may take extra paperwork, but the effort can mean everything to the patient, especially for pediatric patients and women who have family planning considerations.
Encourage Peer Support: Connecting patients with others who have made similar transitions can provide reassurance and reduce feelings of isolation. Patient communities, both online and in-person, can be powerful.
Navigating the Complexity of Informed Consent
True informed consent means patients understand not just the science, but the context of their decision. It’s more than ticking a box—it’s about creating space for dialogue, questions, and partnership. When I received the letter saying Humira would no longer be covered, I alerted my GI team not to sign the new script, as that gives the pharmacy/insurance the ability to switch you. A biosimilar is not able to be prescribed until your doctor signs off on it, remember that.
A thoughtful approach might involve:
Discuss what will happen if symptoms worsen after switching. My GI called me multiple times to comfort me and even prescribed a couple of Xanax pills to ease my anxiety leading up to the switch.
Review the process for switching back (if possible). Have a game plan in place so you’re not scrambling if you notice a change in your health.
Ensure patients know they won’t be left to manage complications alone. Support every step of the way makes all the difference.
Research articles to help you feel informed about biosimilars
An informed patient is an empowered patient. I did some research to help do the homework for you. By reading the articles below you should feel better educated on biosimilars so you feel more comfortable with the switch (if it’s a necessity) and about discussing this further with your care team:
Switching from a biologic to a biosimilar can feel like stepping into the unknown—but it doesn’t have to be done in fear or isolation. With transparency, empathy, and collaboration, patients can be empowered to make informed decisions, feel supported during the process, and maintain confidence in their care.
While some people feel more confident switching from a biologic to a different drug class (for example, Humira to Skyrizi or Stelara to Entyvio) to dodge the biosimilar, others are fearful of building up antibodies to a drug class that is otherwise working. You must weigh the pros and cons and do what you feel most comfortable doing. It’s important to remember it’s only a matter of time until all biologics for IBD have biosimilars, so by switching drug classes you are most likely just delaying the inevitable.
If you are planning to become pregnant or you are currently pregnant and on a biologic or a biosimilar please check out the PIANO registry so you can help pave the way for future IBD families and contribute to research so we have more information about the safety of these medications in pregnancy.
The science behind biosimilars is promising. But the human side of medicine—the fear, uncertainty, and trust involved in change, must be just as carefully managed. I hope after reading this article you feel less alone and supported in your personal health decisions.
Polycystic Ovary Syndrome (PCOS) and Inflammatory Bowel Disease (IBD) are two conditions that can significantly affect a woman’s health, but many may not realize that there is a potential connection between the two. While they are distinct in their nature, the relationship between PCOS and IBD may be more intricate than previously thought. Living with both makes for a complicated patient journey and is not talked about enough.
This week on Lights, Camera, Crohn’s we look at these conditions, how they influence one another, and hear from several women in the chronic illness community who experience both.
What is Polycystic Ovary Syndrome (PCOS)?
If you’re reading this, chances are you are aware of what IBD is, but PCOS may be more of a mystery to you. PCOS is a hormonal disorder that affects the ovaries, typically during the reproductive years. It’s characterized by irregular periods, excess androgen levels (leading to symptoms like acne, excessive hair growth on parts of the body where hair is normally minimal, scalp thinning), and the presence of multiple small cysts in the ovaries. PCOS is linked to insulin resistance, obesity, and an increased risk of developing type 2 diabetes, heart disease, and endometrial cancer and impacts 1 in 10 women who are childbearing age.
The precise cause of PCOS is still not fully understood, but genetic factors and lifestyle choices (such as diet and exercise) play a significant role.
The Shared Link: Inflammation
Both PCOS and IBD are associated with chronic inflammation. This is a key factor that may connect the two conditions.
Chronic Low-Grade Inflammation in PCOS
Research has shown that women with PCOS often have increased levels of inflammatory markers, such as C-reactive protein (CRP). This chronic low-grade inflammation can affect the entire body and is linked to metabolic dysfunctions like insulin resistance and obesity, both of which are common in PCOS. Inflammation in PCOS can also exacerbate other symptoms, such as ovarian dysfunction and difficulty managing weight.
Inflammation in IBD
On the other hand, IBD is fundamentally a disease of chronic inflammation. The immune system mistakenly attacks the lining of the digestive tract, leading to the symptoms of Crohn’s disease or ulcerative colitis. This ongoing inflammation can lead to gut permeability issues, nutritional deficiencies, and an altered gut microbiome. The inflammatory process in IBD is often more severe and widespread than in PCOS, but the principle of chronic, low-grade inflammation links the two conditions.
How Might Inflammation Link IBD and PCOS?
Though PCOS primarily affects the reproductive system and IBD affects the gastrointestinal system, both conditions share inflammation as a common underlying feature. Inflammation in one part of the body can exacerbate the other condition, making both difficult to manage at one time.
Here are a few ways in which inflammation might connect these two diseases:
Gut Microbiome Imbalance: Both IBD and PCOS have been shown to be influenced by imbalances in the gut microbiome. In IBD, the gut bacteria are disrupted, contributing to inflammation and disease progression. Emerging research suggests that women with PCOS also exhibit gut dysbiosis, which could worsen the inflammatory profile in the body. This imbalance may be a link that exacerbates both conditions, potentially influencing the development and progression of each.
Immune System Dysfunction: Both PCOS and IBD involve immune system dysfunction. In PCOS, the immune system may not properly regulate inflammation, contributing to insulin resistance and ovarian dysfunction. Similarly, in IBD, the immune system is dysregulated, resulting in chronic inflammation in the GI tract. A common immune pathway may contribute to the co-occurrence of these conditions in some individuals.
Hormonal Imbalances: Inflammation in PCOS can lead to hormonal imbalances that impact not only the reproductive system but also other systems in the body. Conversely, chronic inflammation in IBD may affect hormone levels, potentially exacerbating PCOS symptoms. For example, inflammatory cytokines may interfere with the normal balance of estrogen and progesterone, further complicating reproductive health.
Metabolic Dysfunction: Both PCOS and IBD are associated with metabolic issues, such as insulin resistance. Insulin resistance often goes hand-in-hand with chronic low-grade inflammation in both conditions, and this can make the management of both diseases more challenging. Insulin resistance can worsen inflammation, and inflammation can increase the likelihood of developing insulin resistance, creating a vicious cycle.
Medication Overlap: Some medications used to treat IBD, such as corticosteroids, can also exacerbate symptoms of PCOS, especially in terms of weight gain, insulin resistance, and hormonal imbalance. Conversely, treatments for PCOS, such as oral contraceptives and anti-androgen drugs, may have side effects that impact gut health, potentially influencing the course of IBD.
Managing the Dual Diagnosis
For those dealing with both PCOS and IBD, managing these two conditions simultaneously can be a delicate balancing act. Treatment plans need to address both the hormonal imbalances of PCOS and the inflammatory components of IBD.
Anti-inflammatory Diet: A diet rich in anti-inflammatory foods, such as fruits, vegetables, whole grains, and omega-3 fatty acids, may help reduce inflammation in both the gut and the reproductive system. A diet low in processed foods and sugar can also improve insulin sensitivity, which is crucial for managing PCOS.
Probiotics and Gut Health: Since both PCOS and IBD involve gut health disturbances, introducing probiotics or focusing on gut-healing strategies could help improve the balance of beneficial bacteria and reduce overall inflammation. However, the use of probiotics should be carefully monitored in IBD patients, as some may have adverse reactions during flare-ups. This is a conversation to have with your GI, as there are many differing opinions.
Medications and Monitoring: Medications for IBD (such as anti-inflammatory drugs or immunosuppressants) should be balanced with treatments for PCOS. A healthcare provider may consider the impact of one treatment on the other, as certain drugs could worsen either condition.
Physical Activity and Stress Management: Exercise can help with both insulin sensitivity and inflammation. Regular physical activity helps control weight and can reduce inflammatory markers in the body. Additionally, managing stress through mindfulness or relaxation techniques can also reduce inflammation and improve overall well-being.
The Patient Experience: Read Firsthand Accounts from Women with IBD and PCOS
When researching articles, one of my favorite parts of the writing process is to connect with patients who live the reality of the subject matter. Having the patient voice—people who are willing to share their firsthand experience to help others is priceless. Here is what women with both IBD and PCOS shared with me:
Kayla: “I am curious how many women with IBD also have PCOS because both my sister and I have it. I am getting put on Letrozole in a few weeks to helpfully get me to ovulate. I also have super high AMH which makes sense if I have PCOS, but it’s extremely high so I assume that also means a lot of eggs which also is the same for my sister. It’s crazy because my sister and I have led quite different lifestyles, but our health conditions have been nearly identical! I’m hoping to join the PIANO study soon after this round of medications.”
Sam: “Both PCOS and IBD affect my body and cause inflammation. It can be really tiring to deal with both. Also, there isn’t a cure for either one. Getting pregnant with both was interesting. I had to be in remission with my Crohn’s and then deal with trying to get pregnant which was difficult because of my PCOS. Family planning is extremely stressful with both conditions. I will say that an IUD and being on a GLP1 and infliximab infusions have helped keep my inflammation under control. I also feel like both are invisible diseases and people just dismiss them.”
Stephanie: “I was diagnosed with PCOS after coming off birth control for the first time in six years when I was 22. I was diagnosed with ulcerative colitis at age 26, nine months after having my first child. I never had any symptoms of uc prior to pregnancy and childbirth. My doctors say there is no correlation between both, but something that has been super interesting to me and my husband is the weight aspect…as you know with IBD there are many periods of time when you’re either using the bathroom 10+ times a day or even afraid to eat because of unknown outcomes, which causes many IBD patients to be underweight. But I’m the opposite. I gain weight during those periods and have a very hard time keeping the weight off with both diagnoses, which I chalk up to the PCOS causing insulin resistance (PCOS is often referred to as diabetes of the ovaries)…even though my labs don’t always show insulin resistance. It’s been extremely hard finding doctors who talk about other ways to help my PCOS without birth control.”
Stephanie also takes Metformin. She says both diagnoses come with their own challenges, but the PCOS diagnosis causes her more frustration since most of the suggestions are just to “lose weight” or take hormones to mask the symptoms of the disease. She is excited to see where the research on this topic and learn more about how the co-morbidities coincide between both diseases.
Jami: “I have IBD, diagnosed after four years of struggling through university (both my twin sister and I have Crohn’s disease). I had a major flare in 2015 and after a year of struggling I had surgery to remove my colon. I have an ileostomy and have had every surgery for Crohn’s since. Rectum removed. Stoma repairs, hernia repairs, fistulas, abscesses. I surprisingly got pregnant easily with my first daughter in 2019 after testing to ensure my surgeries did not disrupt my ability to conceive, but in 2021 I started to struggle to conceive and found out I had PCOS. I went to a fertility clinic to help to conceive my second child, and did not need IVF. Instead, I was given hormones and injections to help me ovulate properly and then I was on progesterone to help maintain the pregnancy for three months. If I’m being honest, I feel the C-vid vaccine screwed with my hormones. I don’t regret getting the vaccine as I’m immunocompromised from my biologic, but it was after the vaccines that my hormones were messed up and I started to have pain with my menstrual cycles (terrible cramping and awful breast pain before and during…which I never had before).”
Lindsey: “Crohn’s and PCOS here! I didn’t get diagnosed with PCOS until 2024 after trying to conceive for a couple of years. My only symptom is irregular cycles and multiple follicles on ultrasounds, so the diagnosis came as a shock to me.”
Gabby: “Living with Crohn’s is already a full-time job, but being diagnosed with PCOS added another complex layer. Both conditions affect my hormones, digestion, and inflammation—and often, managing one feels like it’s aggravating the other. PCOS makes it harder to control symptoms during Crohn’s flare-ups, and vice versa. I’ve learned to be incredible mindful of my diet, avoiding gluten and inflammatory foods to reduce triggers for both conditions. As a Latinx woman, one of the most frustrating things has been finding a way to manage my symptoms without feelings like I have to give up the foods that connect me to my culture. Traditional Cuban and Dominican dishes are rarely considered in medical diets or nutrition plans, and I’ve often felt overlooked in conversations about what’s “safe” to eat. But even with careful planning it’s not always enough.”
Gabby went on to say one of her biggest ongoing challenges is keeping her hormones balanced, especially during periods of high stress, something that often happens during a Crohn’s flare. She says stress tends to amplify both conditions, causing a domino effect of symptoms that can be physically and emotionally draining. Some days, she feels like she’s chasing balance that’s always out of reach.
Maddie: “My uc diagnosis came December 2012 when I was 14, wasn’t 8th grade such a fun year! I was put on mesalamine for the uc and birth control and spironolactone for my PCOS and didn’t have a second thought about either for 8.5 years, until I was 22 and my uc flared in June 2021. After the flare settled in July 2023, I stopped birth control a couple of months later to prepare to try to conceive after the six-month clearance. Stopping HBC didn’t impact my UC at all thankfully, which was a worry. We started TTC in April 2024 expecting it to take a while due to PCOS, but with a regular cycle, we conceived on the third cycle of trying in June 2024. We experienced a missed miscarriage where the baby stopped growing at 8 weeks, but we found out when I was supposed to be 10 weeks. After the miscarriage and D&C, I had a flare that lasted 4 months plus a 3-month waiting period before trying to conceive again.”
Maddie is thankful she was able to manage the flare with a course of budesonide. She did not need to switch maintenance medications.
“PCOS and uc are intertwined in this TTC journey, as PCOS unfortunately carries a higher miscarriage risk. Now that we know my body likely responds to loss and perhaps a full-term postpartum as well with a flare, it makes it much scarier of the risks of repeated losses and flares, and the worries of those make me worried about pregnancy-safe drug options, as well as the dangers of repeated/chronic inflammation on future health and cancer risks, and the worries of never being able to have a live birth or our ideal family size.”
Jenny: “Advocating for yourself is the first step towards healing, regardless of an individual’s situation. For years, I was told my Crohn’s disease and symptoms of PCOS were unrelated. It was a journey of perseverance towards confirming a diagnosis of PCOS and validation that the two are related. Trust your intuition, speak up, and never settle for answers that don’t feel right. Sometimes, the right doctors are the ones who truly listen—don’t be afraid to change your path until you find the care you deserve.
Jenny says it wasn’t until she had a female GI and a female gynecologist that she felt heard and understood. She says making that shift was pivotal in how she lived, improved her confidence, and her understanding of self-advocacy.
Final Thoughts
The relationship between IBD and PCOS is complex, but there are notable overlaps, especially in terms of chronic inflammation, immune system dysfunction, and metabolic disturbances. People with both conditions may face unique challenges, but understanding these shared pathways can help tailor treatments that address the root causes of inflammation and hormonal imbalances. Collaboration between healthcare providers across different specialties, such as gynecology, gastroenterology, and endocrinology, is essential to ensure comprehensive care for individuals managing both IBD and PCOS.
By recognizing these connections, we can better manage these conditions and improve the quality of life for those affected. While research appears to be limited regarding IBD and PCOS, there seemed to be a lot more discussion regarding Irritable Bowel Syndrome (IBS) and PCOS. I hope this article makes you feel seen, less alone, and empowered to discuss any health challenges that you may be experiencing but unsure of.
Crohn’s disease and ulcerative colitis often require medication to keep inflammation under control, but in some rare circumstances, just one medication isn’t enough. Research shows only 40 percent of people with IBD achieve remission within one year of taking a single drug. Dual Targeted Therapy (DTT) involves using two different types of treatments at the same time to achieve better disease control. This disease management plan comes to play when single-drug therapy does not adequately control symptoms or when a more aggressive treatment is needed.
This week on Lights, Camera, Crohn’s we hear from esteemed gastroenterologist Dr. Laura Targownik along with several IBD warriors who have utilized DTT to help manage their IBD.
IBD Dual-Targeted Therapy Options
There are several ways healthcare professionals can help manage IBD with dual therapy.
Biologics and Immunomodulators
More commonly, combining a biologic therapy such as infliximab (Remicade), adalimumab (Humira), or vedolizumab (Entyvio) along with an immunomodulator like azathioprine, 6-mercaptopurine, methotrexate. The purpose of this is to enhance the effectiveness and potentially lower the risk of developing antibodies against biologic drugs.
Biologics and Small Molecule Inhibitors
A newer approach involves combining a biologic with a small molecule inhibitor like tofacitinib (Xeljanz) or upadacitinib (Rinvoq). This can target different pathways of the immune response, potentially offering a more comprehensive approach to suppressing inflammation. This can be used in refractory cases and should only be prescribed by an expert IBD physician.
In patients who do not respond to single biologic therapy, there is growing interest in using two biologic agents targeting different inflammatory pathways. However, this approach is not yet widely supported as healthcare providers weigh side effects risks and this is considered experimental.
Dr. Laura Targownik, MD, MSHS, FRCPC, Mount Sinai Hospital (Toronto), Departmental Division Director (Gastroenterology and Hepatology), University of Toronto gives a case study for when she would consider using two biologics for example: in a person with fistulizing Crohn’s disease, whose fistulas have responded well to biologic therapy, she would consider adding another biologic if they’re still experiencing inflammation in the intestinal lining. Dr. Targownik says medications such as vedolizumab (Entyvio) or an IL-23 such as risankizumab (Skyrizi), mirikizumab (Omvoh), and guselkumab (Tremfya) could help to bring IBD under control.
“As a gastroenterologist, I don’t want to discontinue the anti-TNF because I fear their fistulas will worsen, so it makes more sense for me to add in a well-tolerated biologic like vedolizumab or an IL-23 to try to bring the luminal disease under control,” said Dr. Targownik.
She went on to say that patients support the idea of combining therapy with different mechanisms of action if the safety profile makes sense. Most patients who are in a position where dual therapy would be considered are open to do what it takes to get their disease under control.
Corticosteroids and Other Immunosuppressants
This is not strictly speaking dual therapy because corticosteroids are always used short-term. But prednisone in conjunction with other immunosuppressants can quickly reduce inflammation while waiting for the slower effects of immunomodulators or biologics to set in.
A Look at DTT and IBD Research
Dr. Targownik says the VEGA and EXPLORER clinical trials shed light on the potential benefits of combining biologics.
The VEGA trials looked at the benefit of combining an anti-TNF (golimumab) and an IL=23 inhibitor (guselkumab) to induce remission in people with moderate-to-severe UC.
“The combination of golimumab and guselkumab outperformed monotherapy, with a 15 percent increase in the likelihood of clinical remission and a 20 percent gain in endoscopic response. Patients then received an additional six months of either golimumab or guselkumab monotherapy,” says Dr. Targownik and the group on the dual treatment had higher rates of improvement and remission.
This suggests that the deep remission obtained early through DTT might have a sustained effect, even if you step down to monotherapy.
“The EXPLORER-CD study was an open label trial looking at high-risk patients early in the course of disease,” says Dr. Targownik. They received a triple combination with adalimumab, vedolizumab, and methotrexate for six weeks. By the end of the study, 55 percent were in clinical remission, and 35 percent were in endoscopic remission. As there was no comparison arm, it is not clear whether these rates are higher than what would be expected.”
Consequently, the use of tumor necrosis factor (infliximab , adalimumab, etanercept, and golimumab) in combination with newer agents which target interleukin (IL)-12 and IL-23 (ustekinumab, UST), a4b7-integrin (vedolizumab, VDZ) or a4-integrin (natalizumab), has become an increasing area of interest in patients with disease that is not responding to treatment.
According to a systematic review looking at the efficacy and safety of DTT, “There is an urgent need to optimize treatments for patients” so that they have a better chance of remission, which unfortunately remains unachievable for a large number of people living with aggressive IBD. More research is needed to evaluate what the optimal drug combinations are, as well as dose and frequency to limit the burden of side effects.
The DUET trials are looking at people with Crohn’s disease and ulcerative colitis, much like the VEGA study, to compare the effectiveness of golimumab + guselkumab versus either drug alone. Interestingly, in this study, golimumab and guselkumab are combined in a single medication, so even though there are two active ingredients, it is delivered like a single drug.
“If we limit our discussion to combinations of modern advanced therapies, the combination of an anti-TNF and either vedolizumab or an IL-23 holds the most promise,” Dr. Targownik says. ”The other combination that we are seeing more is combining a JAK-inhibitor with an anti-TNF for people with acute severe UC, where the JAK-inhibitor is used in addition or in place of a corticosteroid trial.”
Personal Experiences on DTT
I’ve lived with Crohn’s since 2005 and luckily have been on the same biologic since 2008. I ran an Instagram poll that asked, “Have you been on dual-targeted therapy for your IBD?” Of the 320 people who responded, 40 percent said “Yes”, and 60 percent said no. Here are some scenarios they share:
Candyce has managed her Crohn’s with infliximab (Inflectra) and azathioprine since 2020. A 10-day hospital stay led her to dual treatment therapy after she received the recommendation from both her rheumatologist and her gastroenterologist. “My GI wanted to try to wean me off the azathioprine in 2022 after a clear colonoscopy, and I flared to the point of her wanting to hospitalize me,” she says. “But I managed to gain remission with prednisone and getting back on azathioprine, along with increasing my Inflectra dose to every six weeks instead of every eight.”
Risankizumab wasn’t doing the trick on its own to control Brad’s IBD, so his GI added 28 days of Rinvoq as an alternative to prednisone. He says, “This really worked wonders. Being on both risankizumab and Rinvoq put me into biochemical remission in less than 60 days.”
Samantha’s daughter, Eloise, was on tofacitinib and vedolizumab prior to her colectomy.She shares that more families are talking about dual therapy options. “The major issue is getting these medications approved from insurance, especially for pediatric patients. Our doctor was able to get us samples of Xeljanz from a local adult gastroenterologist because insurance would not approve it.”
Kate currently takes vedolizumab and upadacitinib to manage her IBD. Previously, many biologics failed her and vedolizumab was the only one that worked, but it did not address her perianal disease. “The Rinvoq is beginning to work,” she says. “However, I will say it caused awful acne (which I’m now on medication for). I’m not out of the woods yet, but I am functioning again, and I can tell that two medications are working on what needs to be healed.”
Courtney has been on Remicade and Azathioprine since 2020, prior to that she was on Humira and Azathioprine. She says, “I had no reservations because I was sick and willing to accept any option that might bring relief. My doctor explained to me that Azathioprine helps prevent antibodies to biologics. Regular blood tests monitor for more serious concerns.”
Along with her Remicade infusions, Lauren takes methotrexate orally each week.I don’t love it to be honest. I feel much more fatigued and nauseous with methotrexate added into the regimen.”
Initially, Danielle was put on azathioprine when she was on Remicade to prevent antibody formation and to help keep trough levels high. She explains, “When Remicade wasn’t working and I switched to Stelara, we decided to keep the azathioprine on since it didn’t give me any noticeable side effects. I have had some liver abnormalities with the azathioprine. So, I’ve had to have blood work and even an MRI of my liver to make sure everything is ok (it is). Now that I’m in remission with Stelara, my doctor gave me the choice of coming off the azathioprine, but I wanted to keep it on because I haven’t been in remission so long.”
Cait receives infliximab infusions, and she takes azathioprine simultaneously. “So far, I’ve noticed a massive difference in the healing of my perianal Crohn’s.”
Katie manages her IBD with Skyrizi and methotrexate. She says the combination makes her fearful at times. “I feel like it is a lot for my body to handle, and I have never been able to tell if that is a true feeling or something that stems from the thought of it. I also want to get off methotrexate within the next year or two to prepare my body for pregnancy. But this combo has provided me with full remission and the best I have felt in years.”
Final Thoughts to Consider Before Trying DTT
It’s important to discuss whether DTT could be for you with your specialized IBD care team as DTT comes with its fair share of risks and considerations. Combining medications can increase the risk of adverse effects, including serious infections due to greater immune suppression. Also, getting dual therapies approved through insurance can be complicated, making the cost and accessibility an issue for patients.
“It is challenging to get coverage for patients to use more than one advanced therapy at a time,” Dr. Targownik says, but not impossible. “Often if a patient has another autoimmune disease, I can get one medication approved for the IBD, and then the other for the other autoimmune disease like rheumatoid arthritis.”
The Takeaway
The effectiveness of combination strategies in IBD has been demonstrated in various studies, but these decisions need to be made on a case-by-case basis, considering your personal disease severity, response to previous treatments, and overall health status. If you are struggling with getting your IBD under better control with one therapy alone, speak to your IBD physician about other options.
**This article has also been published on Tina’s blog: Own Your Crohn’s**
As two bloggers and patient thought leaders in the IBD community, we were thrilled and honored to attend and speak at the Advances in IBD conference in December 2024 in Orlando, Florida. In the article below, we come together to summarize key learnings for our IBD patient and caregiver community.
Management of Crohn’s Disease
Crohn’s can be a very progressive disease, meaning it can worsen over time and cause complications, often leading to fistulae, strictures, and therefore surgery and bowel loss. In a debate between two of the co-chairs, Dr. Miguel Regueiro and Dr. Corey Siegel, as well as throughout AIBD, a key theme was to understand if all Crohn’s patients need advanced therapies (biologics or small molecules) to prevent complications. A good suggestion was to identify those few patients who could be closely monitored but not necessarily put on an advanced therapy. The doctors agreed that almost all patients do need an advanced therapy to prevent progression of the disease. Dr. Siegel brought up an interesting point about risk-stratifying patients via a new blood test called CD-PATH, which allows physicians to better understand if a patient might be low-, medium-, or high-risk for progression of Crohn’s disease.
The conclusion at the conference was that early intervention has made a big difference in terms of improving long-term outcomes for patients. It was shown that there is an optimal time for treatment and missing that window can lead to progression of disease and potentially complications.
From stem cells for perianal Crohn’s to more options for fibrostenotic Crohn’s, many patients are waiting for more therapeutics to gain better quality of life. Patients, however, are also clamoring for more therapies for mild Crohn’s disease. There is a real void in treatment options for mild Crohn’s outside of dietary therapies and occasional use of steroids (< 1-2x a year). As patients ourselves, we advocate for more options whether that’s looking at S1Ps or new therapeutics that can help patients feel safe & comfortable that their disease is being treated.
Management of Ulcerative Colitis
In Dr. Millie Long’s talk on Defining Disease Severity in UC, she shared many pearls. Primary indicators of severity include appearance severity of disease on endoscopy and frequency of use of steroids (more often means another long-term therapy may be needed to quell inflammation). She said to also consider biomarkers (fecal calprotectin, C-reactive protein, etc.) and to keep in mind what prior therapies have been used. Dr. Long emphasized that UC can also progress like Crohn’s, and it is important to use treat to target strategies, including initiating therapy early, monitoring for disease activity using biomarkers and intestinal ultrasound, and aim for mucosal healing.
In Dr. Maia Kayal’s talk on what meds to consider if Mesalamine doesn’t cut it in UC, her key take-home message was, “Your first shot is your best shot.” She said it was important to plan wisely if you have mild to moderate UC and work carefully with your gastroenterologist to identify medication options. Dr. Kayal emphasized that certain biologics may be more effective as a first-line therapy rather than being used after one or two biologics haven’t worked, so to choose carefully. Even if mesalamine doesn’t work, there are multiple biologic options from anti-TNF agents to anti-IL-23 medications, and S1P receptors.
CurQD & IBD
Throughout the conference, CurQD received many notable mentions, which in randomized clinical trials showed efficacy in mild to moderate UC when mesalamine hasn’t cut it. CurQD is a naturally sourced formula. Cura is gut-directed form of curcumin that has been found to reduce inflammatory cytokines, restore barrier function, and positively alter the composition of the gut microbiome. QD (Qing Dai) is an extract of Indigo plants found in clinical trials to relieve bleeding, inhibit inflammation, and promote mucosal regeneration (Naganuma et al, Gastroenterology 2018, Ben-Horin et al, CCFA 2023). Dr. Kayal shared this placebo-controlled trial, that found CurQD was effective for inducing response and remission in active UC patients and has the ability to significantly decrease urgency.
Dr. David Rubin also touted CurQD as an adjunctive IBD therapy option, rather than a singular therapy, much like diet. He said while it may be beneficial, patients need to be cautious about sudden pain or obstructive-like symptoms and communicate how they’re feeling with their doctor.
Insurance barriers
Patients and providers have an uphill climb when dealing with insurance barriers, which makes managing IBD exceptionally challenging and at times frustrating for everyone involved. These proverbial hula hoops we’re all constantly forced to jump through often lead to delays in treatment and unnecessary stress. One key challenge discussed during this session was how to deal with insurance companies denying patients who have not tried 5-ASAs or steroids. Solutions shared included the GI office providing detailed documentation on the following:
listing previously tried and failed medications including steroids,
recent objective findings on endoscopy, imaging, blood tests,
sharing symptoms experienced by the patient,
referencing guideline recommendations, and
outlining the risks to the patient and the costs to the insurance company if treatment is not initiated soon.
Patients can also proactively reach out to their insurance company to determine their preferred advanced therapies and pass that intel along to their IBD team.
Another common roadblock discussed was finding out a medication is not covered or no longer covered by insurance—whether it be biologic vs. biosimilar of off-label dosing.
Patients can discuss appealing the decision with their IBD team during clinic appointments, over the Patient Portal, or over the phone. If your first appeal is denied, keep close tabs on your quality of life moving forward. If you are forced to switch, keep a detailed journal of all your symptoms to paint a clear picture of your reality.
Ask about having your GI submit a letter written by you about your patient experience, along with theirs, and make sure a doctor with knowledge of immune-mediated conditions is reviewing the appeal at the insurance company.
Providers can be supportive by showing empathy, following the latest research and including studies within insurance appeal letters. If a person is symptomatic, it would be important to rule out whether it’s active disease or an adverse reaction to medication.
Biosimilars now and in the future
The landscape for IBD therapies has changed immensely in recent years and will continue to do so in the years ahead. Stelara will join Remicade and Humira in 2025 with six biosimilar options for patients (and insurance companies). One of the main areas of improvement lies in patient education. Oftentimes we hear about the switch through a letter from our insurance company or we’re blindsided at an infusion appointment and told by our nurse that we’ll be receiving the biosimilar moving forward. As should be expected, this results in a great deal of uncertainty, skepticism, and pushback from the patient and caregiver population.
Biosimilars are biologic medical products that are highly similar to an already approved reference biologic, with no clinically meaningful differences in terms of safety, potency, or efficacy. Unlike generic drugs, which are chemically synthesized and identical to their branded counterparts, biosimilars are produced using living organisms and exhibit minor natural variability.
Dr. David Choi presented about how important proactive discussions with the patient community area to instill confidence and help educate about how safety and effective biosimilars are. Currently, four adalimumab and two Ustekinumab drugs have interchangeability, which is a designation from the FDA that allows for patients to be automatically switched (originator drug substituted) at the pharmacy level. Dr. Choi shared that providers can avoid this automatic substitution by selecting “dispense as written” on the original prescription. He went on to share that while improving access, there is also a major cost savings. Biosimilars across all disease spaces are expected to save $38-$124 billion from 2021 to 2025. The future of biosimilars is happening right now with exclusivity for golimumab and certolizumab over in 2024 and with more biosimilars in development.
Final thoughts from AIBD 2024
Overall, the main theme throughout all the educational sessions was that IBD needs to be more than just managed, it needs to be overcome with shared patient decision making. More work needs to be done to determine which patient is right for which therapy. There tends to be too much focus on the risk of therapies, rather than the risk of uncontrolled disease. The overarching goal is for providers to identify high-risk patients before we have severe disease and not be hesitant to use surgery as a treatment option when necessary. Emphasis on the importance of re-thinking the role of diet and nutrition and mental health care in conjunction with advanced therapy, looking at biomarkers 10+ years before diagnosis to see if we can prevent or diminish disease severity, utilizing intestinal ultrasound to measure drug response and disease activity in a non-invasive way, and continuing biologics in pregnancy (Healthy mom= healthy baby) were common themes throughout this fantastic conference.
As patients, we remain hopeful for the future of IBD and committed to improving patient outcomes. Lots of work still to be done, but it is impressive to see how far the science has come in the last 19-20 years since our diagnoses!
Inflammatory bowel disease is increasingly recognized as a condition associated with systemic complications beyond the gastrointestinal tract. Among these, cardiovascular (CV) complications stand out due to their potential impact on morbidity and mortality. One of the presentations I attended at the Advances in IBD conference that took place in Orlando this month explored the relationship between IBD and cardiovascular disease, focusing on the effects of disease activity and commonly used therapies. This week on Lights, Camera, Crohn’s a look at what we need to watch out for as a patient community and how we can be proactive with our providers.
Cardiovascular Risks in IBD
Meta-analyses indicate that IBD is associated with a 24% increased risk of ischemic heart disease. Moreover, there are higher rates of premature (under age 55) and extremely premature (under age 40) atherosclerotic cardiovascular diseases in our population. The underlying mechanisms are multifactorial, but persistent inflammation and disease activity are key drivers of arterial events.
Heart failure (HF) risk is also elevated among individuals with IBD. Notably:
The risk appears greater in patients with ulcerative colitis compared to Crohn’s disease.
Female patients with IBD demonstrate a higher predisposition to HF than their male counterparts.
Corticosteroid use further exacerbates the risk of HF in this population.
Cardiovascular Considerations for IBD Therapies
Anti-TNF Therapy
Anti-TNF agents (infliximab, adalimumab, certolizumab pegol, and golimumab) have been linked to worsening congestive heart failure (CHF). In patients with pre-existing heart conditions or known cardiomyopathy, baseline cardiac assessment is critical. Recommendations include performing a transthoracic echocardiogram (TTE) before initiating anti-TNF therapy and monitoring for new or worsening cardiac symptoms during treatment.
JAK Inhibitors
The use of Janus kinase (JAK) inhibitors ( Tofacitinib, filgotinib and Upadacitinib) raises concerns regarding cardiovascular risks, including:
Increases in low-density lipoprotein (LDL) and triglycerides.
Development or exacerbation of hypertension.
Major adverse cardiovascular events (MACE).
For patients starting on JAK inhibitors, clinicians should:
Discuss the patient’s cardiovascular history and risk factors.
Perform a baseline lipid profile, with a repeat evaluation at 8-12 weeks after initiating therapy.
S1P Receptor Modulators
Sphingosine-1-phosphate (S1P) receptor modulators, a newer class of therapies for IBD (ozanimod, etrasimod, fingolimod and laquinimod), can impact cardiac conduction. To mitigate risks:
Screen for symptoms suggestive of conduction abnormalities.
Review the patient’s drug history for concurrent use of anti-arrhythmic agents or drugs that prolong the QT interval.
Perform an electrocardiogram (ECG) prior to initiating therapy.
Clinical Implications
Cardiovascular complications are common in patients with IBD, often presenting at a younger age than in the general population. The association between active disease and increased CV risk highlights the importance of maintaining disease control. Non-steroidal options for long-term management should be prioritized, as corticosteroids exacerbate both IBD and CV risks.
Therapeutic decisions should also account for the cardiovascular safety profile of IBD medications. High clinical suspicion and proactive monitoring are essential for detecting underlying or developing cardiovascular disease in IBD patients. Understanding the risks associated with specific therapies, such as anti-TNF agents, JAK inhibitors, and S1P receptor modulators, can guide personalized treatment plans and improve long-term outcomes. When meeting with your gastroenterologist communicate any concerns you may have about chest pain or your blood pressure.
Closing Summary
Cardiovascular complications in IBD patients necessitate a high level of vigilance from healthcare providers. Early detection and management of cardiovascular risks are paramount, particularly in young IBD patients who may already be vulnerable to inflammation-driven atherosclerotic changes. A tailored approach—balancing effective disease control with an awareness of therapy-specific cardiovascular risks—is critical to optimizing care in this complex patient population.
If it’s happened to you, you know the feeling all too well. When I received a letter in the mail informing me that the biologic injection, I had been on for 16 years was no longer going to be covered, my stomach flipped, and my heart sank. When you live with a complicated disease like Crohn’s or ulcerative colitis and find a therapy that keeps your health in check and your IBD well-controlled, it’s extremely stressful and daunting to face the worry of being forced to switch your medication to a biosimilar or a different biologic all together.
Like many patients, I asked my gastroenterologist to appeal the forced medication switch. Even though I was almost positive we would be denied, I did not want to go down without a fight. As expected, within days of my GI’s appeal, we were told by insurance that Humira would no longer be covered and that I would need to choose a biosimilar or a different drug class all together moving forward.
I chose to go on the biosimilar Hyrimoz for many reasons—the first being that anti-TNF drugs have worked well for me for YEARS, by choosing to go off it and switch to a different drug class, I ran the risk of building up antibodies and possibly not responding as well to treatment. I also have a comfort level with self-injections and know how I have typically responded to anti-TNF medication in the past.
The emotions and heartache of having to say goodbye to a medication that carried me through for 16 years, allowed me to bring three healthy babies into this world, and stay out of the emergency room and hospital since becoming a mom 7.5 years ago tore me apart. I sobbed. I stressed. I was anxious.
Switching to a biosimilar—the emotional and physical toll
Much to my dismay, I started Hyrimoz in July 2024. The first eight days I felt the same and then my health began to crumble. I lasted four injections—and during that time I went from being in deep remission for years to needing pain medication to make it through elementary school PTO meetings and while coaching my kindergarten soccer team. I went from feeling well most of the time to running to the bathroom 15+ times a day and almost having accidents in public. I went from being able to eat whatever I wanted to worrying about how consuming anything was going to make me feel. I spent nights curled up in pain and days feeling bloated and on edge about whether every decision I made was going to make me unwell.
I knew something had to change. I refused to have my quality of life ripped from me without speaking up. I kept a detailed journal every single day since I started the biosimilar. I articulated my concerns to my care team repeatedly over the Patient Portal. We ran extra labs, I did a telehealth appointment, I spoke with GIs around the United States I have come to know and trust through my patient advocacy work. My care team told me that meeting in person for a clinic appointment or over telehealth would help build our case, as that carries more weight than just communicating over the Portal. Keep that in mind.
This week on Lights, Camera, Crohn’s I offer tips for building your case, writing your appeal letter, and making sure your voice is heard. Patients are constantly made to feel less than. It’s all about the profits and not about the patients. This needs to stop. Insurance companies and specialty pharmacies need to stop making our lives so damn difficult and start to recognize the havoc they cause by delaying treatment, blocking treatment options, and forcing us to change a medication that finally controls our disease. Living and managing chronic illness is a full-time job in this country. The hours and days wasted and spent on the phone dealing with all the red tape is an absolute nightmare, and unless you’ve experienced it, you have no clue the headaches it causes, the time suck it is, and how it puts the quality of our lives in jeopardy.
Keeping track of it all
When living with IBD, the bad days come and go and oftentimes we forget just how often or how horribly we feel because our “normal” is not normal. By journaling or writing in the Notes app on your phone anytime anything with your health is awry, this helps paint a clear picture for not only you, but your providers. If you can say, “On Tuesday, September 24th I went to the bathroom 10 times, I couldn’t eat, I had joint pain in my hands, and abdominal pain that required a heating pad”—this illustrates the complexity of your symptoms. Imagine having that type of intel for two months. These details help your appeal in a big way. My IBD Nurse told me that she believes my typed-out symptom journal made all the difference in winning our second appeal.
So, take notes and be as descriptive as possible. If you have a random headache and you’re not sure why, write it down. If you get new pain, you haven’t experienced before keep track of it. If you eat and must run right to the bathroom or start feeling pain jot it down.
Many of my symptoms I’ve dealt with since switching to the biosimilar feel exactly like a Crohn’s flare. After weeks of this, I started to freak out that I was losing my remission all because of a forced medication switch. A world-renowned GI took the time to call me as I was making dinner for my family one night to hear more about my situation. He did this out of the goodness of his heart to provide additional guidance and support. After hearing more about my situation, he believed it was my body having adverse side effects to the biosimilar rather than a Crohn’s flare, since my labs were checking out fine. Everything started to make sense. While he wasn’t sure our appeal would be granted, he listened and empathized with what I was going through.
Writing your own appeal letter
My IBD team recommended I also write a patient letter that they would include with their second appeal. I was happy to take the time to offer my voice and share what the experience of being on a biosimilar was like for me. At the same time, I had never written an appeal letter. Before I started I did my research on how to approach and craft the wording.
I made sure not to come off angry or accusatory. I kept the letter as professional as possible, while also explaining very clearly how horribly I was responding to the medication. I backed up my letter with science and attributed research that’s been done regarding biosimilars. I learned from research published in the Journal of Crohn’s and Colitis (2020) that while around 80% of patients have a seamless transition, 10-20% have a negative response. It’s important to note that just because you are switched to a biosimilar, does not mean your health will deteriorate. Many people thrive and don’t notice a difference, but the issue is—you don’t know how you are going to respond. I went into the transition with an open mind and as positive as possible, but the unknown looms over and it’s emotionally draining to constantly wonder if you are going to feel unwell because of the forced switch.
Tips for expressing yourself in the appeal letter
I will use Humira as an example since that was my experience, but this goes for any biologic/medication.
Start with basic information—your name, date of birth, insurance ID number, and the policy number.
Provide the name of the medication you’ve been switched from (in my case Humira) and the one you’ve been switched to (Hyrimoz).
Mention the date when the change was made.
Clearly state the purpose of the letter. For example, “”I am writing to formally appeal the decision to switch my Crohn’s treatment from Humira to Hyrimoz.”
Briefly provide an overview of your health history with IBD, diagnosis date, and the treatments you’ve tried, hospitalizations/surgeries. If you’ve been on the same treatment for years and it’s helped you, highlight how effective the therapy has been. Mention the stability you’ve achieved with Humira—humanize your story. For instance, “While on Humira I was able to work full-time, have three healthy pregnancies and babies, and be a mom without my health holding me back.”
Reference any previous experiences with other medications that may have failed you or caused side effects.
Emphasize the risk of switching medications after long-term success. For IBD patients, changing medications can result in loss of response, worsening of symptoms or disease progression, potential adverse reactions.
Have your gastroenterologist provide their own letter that emphasizes the risks of switching, the stability you’ve achieved, and their professional recommendation. They will reference any studies that are available and be able to provide medical records showing your history on the medication.
If applicable, reference and cite insurance company policies that include provisions for medical necessity, or any pre-authorization that was previously approved.
Emphasize the impact on your health and finances and highlight the potential cost to both your health and your insurance provider if switching leads to disease flare ups, complications, hospitalizations, or the need for additional screenings, scopes, or treatments.
Close with a strong, respectful request. End the letter with a clear statement, such as:
“For the reasons stated above, I respectfully request that you reconsider your decision and allow me to remain on Humira as prescribed by my doctor.”
I signed my letter:
My family deserves more and so do I.
Sincerely,
Natalie Hayden
Ironically, when I wrote my appeal letter I was dealing with horrible abdominal pain, lying in bed with a heating pad.
Finding out we won the appeal
Once my appeal letter and journal of symptoms were finalized, I sent them to my GI and IBD nurse over the Patient Portal. I was on pins and needles wondering what was going to come next. I sent over the materials on a Friday morning and the following Monday, I received word from my nurse over the Portal that the insurance denied the 2nd appeal because back in June when my GI submitted the first appeal, he deemed it “urgent”—in doing so, the insurance company considers those appeals “2nd level appeals”—if those are denied, they consider the case closed. Imagine that— “closing a case” before a patient has even started a different medication. Makes sense…right?! Can’t make this stuff up. When I heard this, I felt incredibly defeated.
My care team was unaware of that and asked for a clinician to review our materials—the insurance company agreed and said there would be a decision in 72 hours. That same night, while I was making dinner for my family, I received an email from CVS Specialty pharmacy saying my prior authorization for Humira had been approved. I couldn’t believe my eyes. I’ll never forget how it felt to see those words and read that email.
My kids all smiled and laughed and danced with me, no idea what was really going on. But the celebratory moment was so incredibly jubilant they were smiling ear to ear. These last two months they’ve witnessed me unwell way too many times. It’s a side of my Crohn’s I’m not sure they even knew existed prior to now.
This past Friday night the same abdominal pain I’ve been dealing with began as the kids got off the bus. I had to take a pain pill before an advocacy call that was ironically about How to Deal with Insurance—for an upcoming panel discussion at a medical conference I’m speaking at in December. After my call and rushing through a makeshift meal, I took all three of my kids to my son’s soccer practice and told my friends on the sidelines how sick I felt. I came home and had to take another pain pill, had difficulty with the bedtime routine, and laid on the couch with a heating pad. But it helped to know these shitty days will hopefully be ending.
Looking to the future
This blog article is coming out the same day as I go back on Humira after winning my insurance appeal. While it’s a big win for me, it’s a small win for our community because at the end of the day an incomprehensible number of people are forced off their medications or denied off-label dosing, all so insurance companies see a better bottom line. As patients we can’t stand for this. Medical providers should and need to have the FINAL say in what medications their patients are on and they should always be willing to go to bat for their patients and appeal even if they “know they’ll get denied.” I hear all too often from fellow patients that their GI won’t even appeal in the first place and does not empathize with the fear of being forced on a biosimilar.
For those providers, I ask…can you guarantee, 100%, no doubts whatsoever that your patient will thrive and do just as well on a biosimilar as they did their originator biologic? Does the benefit really outweigh the risk? Should IBD patients who already live with an unpredictable and complicated chronic illness have to endure the stress, medical trauma, and anxiety that result from forced medication switches or denials related to off-label dosing?
As patients, caregivers, and medical providers we are a team. We know what’s right. Doctors and nurses should not have to waste so much energy on fighting for off-label dosing, necessary treatments, and keeping their patients on medications that are working. A HUGE thank you to all the providers and nurses who go above and beyond and out of their way to fight for us and do everything in their power to make sure we receive the medical treatments we need to keep our IBD in check. Your efforts, whether successful or not, are not going unnoticed.
At the end of the day, the big argument is all about “accessibility” and “cost savings” in the United States, but are patients really reaping this benefit here? I paid at most 0-$5 for Humira injections, I paid $0 for Hyrimoz. Do you know how I paid? I paid with living more than two months with health issues that would bring the average person to their knees. I went from being in deep remission to re-living the trauma of how unpredictable life with IBD can be. I paid by being on a biosimilar for 71 days and spending more than half of them with debilitating pain and symptoms.
Big pharma can step up to the plate and lower their absurd pricing on biologics (originator drugs) so that biosimilars are of no monetary benefit to pharmacy benefit managers. Let’s make it an equal playing field and see what happens. Would Big Pharma rather lose all their patients because their biologic is being removed from the insurance formulary or keep patients, lower their costs of the drugs, and keep insurance companies from choosing biosimilars because it saves them money?
As a vocal IBD patient advocate and leader, I understand and feel for those who haven’t been able to go back on therapies or receive different dosage recommendations they depend on for their well-being. While I’m thrilled to be back on my biologic, now I have the worry about whether my body will respond the same as it did previously.
The medication I’ve depended on for 16 years to bring me comfort is finally back in my fridge and going to be back in my body today. The prior authorization lasts one year, so I’m not sure what the future will bring, but I’m focused on getting my health back on track right now and worrying about that later. I’m grateful my energy in dealing with my own appeal is over and now I can pour my efforts into trying to drive change for our community. We all deserve so much more. Let’s go after what is right and make forced medication switching and off-label dosing delays and denials by insurance companies illegal in the United States.
Imagine a medication that not only helps shed unwanted pounds but also holds the promise of alleviating the painful and debilitating symptoms of inflammatory bowel disease (IBD). For millions battling the dual challenges of IBD and weight management, this could be a game-changer. Some reported data suggest approximately 15 to 40% of IBD patients experience obesity. As obesity has been linked to more severe disease activity, anti-obesity medications, such as GLP-1 (glucagon-like peptide-1) receptor agonists (RA), could be a novel treatment strategy for IBD.
Recent research into GLP-1RA medications, primarily known for their role in weight loss and diabetes management, suggests they might have unexpected benefits for those with Crohn’s disease and ulcerative colitis. Could these medications pave the way for a new era in IBD treatment? This week on Lights, Camera, Crohn’s let’s dive into the intriguing possibilities that lie at the intersection of weight loss and inflammatory bowel disease management. You’ll hear from gastroenterologist and researcher Dr. Aakash Desai, along with 25 people who have IBD and have tried or are currently taking GLP-1RA medications.
What is a GLP-1RA medication?
GLP-1 (glucagon-like peptide-1) medications are primarily known for their role in managing type 2 diabetes and obesity. GLP-1 agonists, such as liraglutide (Victoza), semaglutide (Ozempic), and dulaglutide (Trulicity), mimic the action of the endogenous hormone GLP-1. These drugs enhance insulin secretion, inhibit glucagon release, slow gastric emptying, and promote satiety, thereby aiding in blood glucose control and weight loss.
The majority of these drugs are subcutaneous injections, with only one currently available orally. The frequency of taking the medication varies with each GLP-1RA and can be weekly, daily, or twice daily. But, the typical dose is a weekly self-injection, which can be done in your stomach, upper arm, buttocks, or thigh.
The Mechanistic Link to IBD
Anti-inflammatory Properties: GLP-1 receptors are present in the gastrointestinal tract and on immune cells. Activation of these receptors has shown anti-inflammatory effects in preclinical studies. This suggests that GLP-1 medications could theoretically modulate immune responses and reduce inflammation in the gut.
Mucosal Healing: Animal models have demonstrated that GLP-1 agonists can promote mucosal healing in the intestines, a critical aspect of managing IBD. This potential for enhancing intestinal barrier function and reducing inflammation holds promise for IBD therapy. Scroll to the bottom of the article to check out the latest research.
Considerations between providers and patients
Dr. Aakash Desai, MD, Allegheny Health Network in Pittsburgh, Pennsylvania says that before discussing if GLP-1RA is appropriate for his patients, he tries to understand their weight loss journey on a case-by-case basis.
“This is unique for every patient, so it’s important for the physician to understand where they’re at and the efforts that have been made. I like to ask what type of dietary and lifestyle modifications they have attempted, exercise (finding out actual numbers, number of days/minutes per week of exercise, moderate/strenuous intensity), prior consultations with nutrition and/or weight loss specialist, and prior exposure to weight loss medications. It’s also important to consider comorbidities, especially history of pancreatitis, gallbladder disease, type 2 diabetes mellitus, and psychiatric diseases including eating disorders.”
He tells me a “good” candidate is a patient who is obese or overweight with weight-related complications who is willing to undergo lifestyle interventions in close collaboration with nutrition and a weight loss specialist. From an IBD standpoint, before starting on this type of medication, Dr. Desai likes to see his patients in remission.
“GLP-1RA medications have several GI side effects, so it can be challenging to differentiate if a patient’s symptoms are related to GLP-1RA, active IBD or both. Patients should have their IBD in remission, clinical and endoscopic, and radiographic, if applicable,” explained Dr. Desai.
There is preclinical data suggesting that GLP-1RA can modulate inflammatory responses.
Dr. Desai explained, “Mechanisms include its impact on oxidative stress, immune cell recruitment, cytokine production, and gut microbiota modulation. There is also some clinical data from retrospective studies showing improved IBD outcomes, however we need data from prospective studies to see if these medications can be used as adjuncts with existing IBD therapies.”
He would not recommend starting GLP-1RA for obesity management during a flare/active disease given the risk of drug related GI side effects. This could worsen symptoms which could inadvertently lead to increased dose of steroids, prolonged steroid use or a change in IBD therapy. Additionally, providers prescribing GLP-1RA have a low threshold to discontinue the medication if patients with IBD develop even mild GI symptoms out of potential concern for worsening IBD.
Ongoing research underway
Dr. Desai is working on a study that involves 150 people with IBD who are obese and taking semaglutide.
“We found similar weight loss compared to patients without IBD. We also found higher weight loss with semaglutide compared to other anti-obesity medications except tirzepatide. We did not observe worsened IBD specific outcomes in patients on semaglutide. In another study from a large database, we found that GLP-1RA use for type 2 diabetes in patients with IBD was associated with a lower risk of surgery for ulcerative colitis and Crohn’s disease, but we did not observe a lower risk of steroid use.”
He tells me it’s important to note that this is retrospective observational data. However, Dr. Desai hopes this sets the stage for prospective studies and future randomized controlled trials.
From a safety standpoint, there is limited data, however it appears to be reassuring for serious side effects. Dr. Desai believes until we have more robust data, the key will be disease remission at the time of initiation of GLP1-RA. Keep this in mind if you are dealing with active disease and hope to start this type of medication.
There is no data to suggest that patients on biologics or small molecules cannot be on a GLP-1RA if their disease is in remission. The approach needs to be individualized factoring in clinical characteristics and disease profile.
Scope and Scans and GLP-1s
There seems to be confusion in the patient community about how these weight loss mediations can impact how we prep and undergo scopes and scans. Dr. Desai says there is currently no data supporting stopping GLP-1RA before elective endoscopy – which is a multi-society statement.
“I follow the clinical practice update published by American Gastroenterological Association (AGA) which suggests an individualized approach to each patient. If patients are on GLP-1RA only for weight loss, I think there is little harm in holding the medicine a week before elective endoscopy. An alternative would be to continue the GLP-1RA and place patients on a liquid diet the day before the procedure.”
Dr. Desai says he likes to discuss extended bowel prep (2 days) with his IBD patients.
“Alternatively, I recommend a low fiber low residue diet for 5 days plus 2 days of a clear liquid diet with 1 day of prep. I would encourage patients to discuss management of GLP-1RA and bowel prep with their IBD providers prior to elective endoscopy as institutional protocols especially for anesthesia may vary.”
Hear what an IBD mom has to say about her experience
Emily says she’s been overweight most of her life. She tried everything to lose weight, and nothing seemed to work—or she’d lose weight and gain it right back. She talked with her primary doctor about the weight loss medications and her provider is a big fan of them for the right person and thought they’d be a great fit for her. As an IBD mom of two boys, Emily was worried about what her gastroenterologist would have to say.
“At first, I was nervous about it because I didn’t want him to tell me I couldn’t do it. But he was okay with it. He said if I didn’t have any IBD complications, that I would be fine to be on it. He didn’t have any hesitation since I have been in remission and my colonoscopy and upper endoscopy looked good. I explained that I was followed closely with my primary and that I would let him know if I had any issues that came up. Thankfully, my Crohn’s has stayed in remission!”
Emily started semaglutide in November 2022 and was on that for 7 months and then switched to tirzepatide. She’s now been on that for one year.
“I am starting the process of going into maintenance and will decrease my dose until I find what works for me and plan to stay on this long term.”
Emily’s remarkable transformation from 2022 to now.
She’s currently taking Stelara to manage her Crohn’s. Emily is down 93 pounds, and she feels amazing. She says she has dealt with minimal side effects—some nausea and constipation, but nothing that lasts long. As most of us are, she’s very conscious of her bathroom habits and says if she starts to feel constipated, she takes stool softeners.
Firsthand experience from an ostomate
Elizabeth has perianal Crohn’s and has participated in two clinical trials (stem cells). She has had two gracilis flap surgeries, among others. She says while many IBD patients struggle with keeping weight on, this has not been the case for her.
“I have always been in a larger body (even before my Crohn’s diagnosis 20+ years ago). I workout daily and eat a balanced diet but have, like many, found a natural weight plateau. Since my bloodwork always looks great, I really hadn’t thought about it as it would be seemingly for vanity’s sake.”
With more than a dozen IBD surgeries so far and at least one or two more in the future, she was discussing with her GI wanting to optimize future success post-operatively, when her doctor brought it up.
“Since I carry more weight in my mid-section and currently have a loop ileostomy, which also is poorly placed and with a hernia that causes further projection, addressing those issues was certainly on my mind. I was open to learning more and she was bullish, referring me to a fellow GI doctor who specialized in the area.”
As an ostomate, Elizabeth was concerned about blockages, in addition to insurance not covering the cost.
“My consulting doctor felt confident I was a good candidate, and we both thought it may actually improve my fast GI tract and high-output ostomy (which had been causing daily leaks recently). While insurance denied two different options based on plan carve outs, even after appeals, I decided to try paying out of pocket.”
She started on Zepbound four months ago, in conjunction with her biologic and small molecule medication to manage her IBD. Elizabeth says she was less concerned about adding a medicine but, like many of us, would like to be on fewer longer term.
So far, she has lost 30 pounds or about 12% of her starting weight!
“I wasn’t at my highest all-time weight, but I had gained. The effect was almost immediate for me — with the biggest short-term (and continued) win being the delayed gastric emptying, meaning less liquid output, less rapid output, and less visits to the bathroom to empty. I also stopped having leak issues almost completely and, in conjunction with my IBD meds, my symptoms and inflammation are the best they’ve been in years.”
In terms of the non-IBD effects, the impact on what they call “food noise” was huge and, because food stayed in her stomach for more than an hour or two, her hunger changed dramatically.
“I can’t explain how odd it feels to have to remind yourself to eat and to simply feel full. Fortunately, I have had few side effects as, thanks to my ileostomy, I was already focused on staying hydrated.”
Elizabeth encourages those with IBD to research and consult with a doctor who specializes in obesity medicine (and versed in IBD and/or willing to work with your IBD team). Unlike many of the medications we use to control our disease, antibodies aren’t a concern, and it could be worth a try. Also, she says not to be discouraged if it doesn’t work for you as, just like IBD meds, what works for one person may not work for someone else.
“While the weight loss is great, the impact on my IBD-related quality of life has been just as important. I hope there is more research in this area and potential a path for these medications to be considered as part of a covered treatment plan for patients with IBD and other chronic conditions.”
What other IBD patients have to say
Thank you to those who submitted input for this article—there’s nothing like hearing firsthand perspectives from those living our reality. I have purposefully left all the quotes anonymous.
“I have been on Wegovy for over a year, and I have ulcerative colitis. I’ve had a positive experience and from what my GI told me, there are clinical trials going on for its effect on IBD patients specifically.”
“I started Ozempic last week. My GI approved it. There is lots of research about reducing inflammation, along with other benefits. I am way overweight, and I needed help.”
“I’m on semaglutide, which is the generic compound of Wegovy. My GI approved it and it’s been great. It’s the only way I’ve been able to lose weight in years! It has helped me with cravings, with blood sugar stability, and with my emotional connection to food. The first six weeks, I lost my interest in food and had a weird metal taste in my mouth. But slowly that went away and now I am back to myself but feeling more in control and with a healthier view of food. I have not lost weight as fast as some, more like 1-2 pounds a week with a plateau where we found the dosage needed to be increased. Slow and steady has been fine for me.”
“I have ulcerative colitis and got a jpouch back in 2010. I was on Ozempic last year but got off to get pregnant. Once I’m six months postpartum I was told I could go back on it.”
“My CRP is back to normal, even though my SED rate is still elevated, my IBD is non-existent. My constipation did get worse though. But it’s nothing that daily Miralax can’t help. I had to come off it because it made my anxiety worse. Being on that medicine made me as close to feeling like a normal human being as ever.”
“I have been on Ozempic for the past month. No lie, best I’ve felt in years! It’s taken my 20 bowel movements a day down to 3-4. I have nausea, but it’s tolerable. I don’t have diabetes, so I’m paying out of pocket for it. Those with diabetes get a greater benefit from it. You have to be serious about eating protein and about eating better. Since the food you eat sits in your stomach longer, you’ll feel sicker if you’re just eating junk.”
“I would love to hear more about this as IBD is one of the contra indications for this medication and is not usually prescribed in the UK for people with Crohn’s/ulcerative colitis, as it can cause GI upset. So, I would love to hear more about people’s experiences with this as this is something I have looked into for my weight, and I have Crohn’s.”
“My PCP said in her experience they have helped GI outcomes, but I haven’t talked with my GI to see his response. I will say, as an OR nurse, we have been seeing a lot of exploratory laparoscopic surgeries with patients on these medications.”
“I have UC and they put me on Ozempic last year! One shot and I couldn’t stop vomiting. I lost 35 pounds, but I had to take Zofran daily and used a Scopalamine patch so I would not vomit. I started in April, and I didn’t get better until July or August. I went into the ER and urgent care several times for dehydration. It was mild pancreatis, but my labs were not bad enough for them to admit me.”
“I was on Victoza! My GI symptoms were exacerbated by the medicine, but my A1C went down significantly. Unfortunately, I was throwing up for the first month I was on it and because of that my appetite was not suppressed.”
“I was on Ozempic. It made me nauseous and sick. I had terrible stomach pains and TMI, but super gross mucus-y stools. As soon as I stopped, everything went back to normal. I lost 20 pounds and then gained it all back immediately.”
“I have Crohn’s and I’ve been on Saxenda for 8 months and I’m down 20 pounds. Other than a little nausea in the beginning, it’s been great for me!”
“Started semiglutide injections 2 weeks ago and I’ve been able to stop taking my Loperamide completely (I have ulcerative colitis and a jpouch). Semiglutide wasn’t covered by insurance even with appeals for weight loss and motility, but I got it pretty affordable online through Henry Meds. I’m still on the loading doses but haven’t had side effects so far. It takes about 2-3 months of weekly injections to build up to a full dose.”
“I experience nausea day two after taking the shot. Other than that, I haven’t dealt with anything negative. I lost weight that wasn’t coming off due to hormones being completely screwed from pregnancy and 60 mg of prednisone for almost 9 months. GLP-1s also constipate you, due to your gut not emptying as quickly as it normally would. This is one of the reasons it’s being explored as an IBD option. Taking magnesium, bulking up on fiber or taking fiber helps with this.”
“I am on semeglutide week 6 tomorrow—this is my second time—I did it last summer for about 3 weeks. I went up on my dose last week, I haven’t noticed a difference with anything yet, but I haven’t changed my diet much and that’s on me. There’s no difference in my ulcerative colitis symptoms, I’ve had mild active uc for awhile now. I’m trying to get it under control, but also need to lose a bit of weight.”
“Back in 2022, I was on Mounjaro for about 8 months. I was finally able to lose weight. I am a Crohnie who gains weight because my body has a hard time digesting nutrients. Because of this, my body is in starvation mode a lot. When I was on Mounjaro, I lost about 80 pounds, and my inflammation was well managed. It was the first time I was able to feel energetic and wasn’t tired all the time. It helped with my diarrhea because it made me constipated for the first time in 5 years. It then became regulated. I still had stomach pains and indigestion issues, but overall, the medication improved my quality of life quite a bit. I am pre-diabetic and now my insurance will not cover it. My doctor tried appealing it many times, explaining that Mounjaro was helping to manage my inflammation caused by Crohn’s disease, and they still denied it. I have gained 30 pounds back and have a hard time with energy and my diarrhea has returned on and off.”
“I’m on Mounjaro and taking it specifically to help with my high output ostomy. I have Type 2 diabetes, so I’m able to get it through insurance luckily, since we’re using it “off label”. A friend of mine who has a jpouch was on Saxenda, then Ozempic, for the same reasons. She recently had to go off it because of new insurance and she developed pouchitis within weeks of having to stop it. I have two other friends with ostomies taking it, both with a history of Crohn’s. One is a CEO of a biotech company and has been chatting with the different GLP-1 manufacturers trying to convince them to do trials in patients with short gut or high output ostomies.”
“The first thing I asked my GI doctor is HOW can someone have IBD and be overweight or obese? And he said it’s quite common! When I started to flare, he wanted to blame the diarrhea on GLP-1 (Wegovy). But I asked him for a colonoscopy which showed active ulcerative colitis, unrelated to the medication. I am now on Zepbound. For some reason, these medications don’t help me lose weight. I can’t help but wonder if the inflammation from IBD is preventing successful weight loss. I can have many bowel movements a day and not lose a single pound!”
“I have had a good experience with it. I have a really tough time eating vegetables and some fruits, nuts, etc. because of my Crohn’s. The fact that the medication decreases that hunger helps me maintain a healthy weight. I tell people that all the “food noises” I used to experience are gone.”
“I am researching this for Crohn’s myself. I am interested to see your article and opinion. I’m in the UK and recently heard about the benefits of microdosing and I wanted to see if IBD people had experienced positives.”
“I was originally on Ozempic, and it wrecked my stomach. I had to take a break from it, but I lost weight. I switched to Mounjaro due to insurance and have had way better luck with no GI issues. Altogether, I have lost almost 50 pounds. I should mention that I am pre-diabetic. I have a really hard time losing weight. When I was pregnant, I lost 35 pounds after I gave birth and didn’t gain a pound during. I felt amazing, not sure why I wasn’t hungry when I was pregnant. Mounjaro has allowed me to not think about food 24/7. It’s been a game changer.”
“I’ve Googled it before (because who that’s overweight hasn’t been at least curious) and I remember reading that because it slows digestion it can help IBD patients. I’m still worried about the unknown long-term effects to try to it.”
Final thoughts
It’s important to understand that these are chronic medications for obesity management. GLP-1RAs are not a substitute but should be used in conjunction with lifestyle interventions including diet and exercise. This is necessary for sustained long-term weight loss. This requires a multi-disciplinary team-based approach with nutrition, weight loss specialist, primary care and your IBD provider.
As you heard from the patient community, access and cost for these medications remains a key issue for many. The high cost and complex insurance landscape pose significant barriers for many patients seeking these treatments. The monthly cost of these drugs in the United States can range from several hundred dollars to over one thousand dollars, presenting a substantial financial burden for patients. Many insurance companies require prior authorization for GLP-1RA medications, necessitating extensive documentation and justification from healthcare providers. This process can be time-consuming, and as we’re all too familiar with, may delay treatment.
I’ll leave you with an impactful quote from Emily, “I think for the right person these meds are life changing. I know for me they have been. There is a lot of chatter on both sides, and I have learned to block it out. I work closely with my primary doctor and know that she would never steer me wrong. I also know that my GI is on board and that has helped, too. Don’t let the opinions of others deter you. If this is something you want to do and you have the support from your doctors that is all that matters!”
More than 4 million babies are born in the United States each year, many to mothers who live with chronic illness. Historically, pregnant women are excluded from research, consequently there is limited to no safety data at the time of drug approval. Enormous gaps remain regarding the clinical impact of exposure to biologics and medications when so much is at stake for both mom and baby. July 11-12th the Food and Drug Administration (FDA) hosted a public workshop entitled, “Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products.”
As a patient leader in the IBD community and mom of three children who were all exposed to anti-TNF medication in pregnancy, I was invited to provide the patient voice during this two-day discussion. I spoke on three different panels to share my perspective. This week on Lights, Camera, Crohn’s I’ll share what I learned and what I heard from top researchers and doctors at the workshop. The key overall message—healthy moms lead to healthy babies and a healthy society. Healthy meaning—having disease well-controlled in pregnancy so flares don’t lead to adverse outcomes for both mom and baby.
Pregnant women and lack of research
Often due to ethics, pregnant women have been omitted from research and clinical trials. The absence of human involvement in pharmacology studies can lead to uncertainty about what is deemed “low risk” and “safe” to the fetus, and the impact medications have on the placenta. Women who become pregnant must drop out of clinical studies, even if the drug class has known safety or is deemed low risk (anti-TNF, IL-23s).
It’s clear that reducing or stopping medications can put mothers at risk for flares, which in turn can lead to adverse effects in pregnancy. With my own children, I stayed on Humira until 39 weeks with my oldest (who is now 7), and 37 weeks with my other two children (who are now 5 and 3). All three of my children were a part of pregnancy studies (MotherToBaby and PIANO). My youngest will be followed until age 18! My oldest was followed through kindergarten. The current recommendation, globally (which has changed since I had my children) is to keep women on biologics throughout the entire pregnancy.
One of the key areas of discussion is whether animal data from research ever tells us the whole story about the safety and efficacy of medications—the answer is no. There is no substitute for a human placenta, but the challenge and dilemma are what can be done to get this human data. Approaching clinical trials in pregnant women is challenging and takes time to develop. Currently, animals are the best tool we have for educated guesses.
The benefit vs. risk discussion for Mom and Baby
Oftentimes decision making with chronic illness is a risk versus benefit thought process, whether you are pregnant or plan to carry a baby in the future or not. During the FDA workshop, there was an incredible presentation that really resonated with me about the multiple decisions women have to make for both themselves and their unborn children. The discussion highlighted the complexity and why it’s not a black and white decision. These series of decisions are nested in each other and revolve around the decision maker (Mom/Dad) and medical providers.
Key considerations we deal with as IBD moms:
Continue or discontinue medication?
Should we breastfeed on medication?
Should we give an attenuated live vaccine as scheduled or delay?
When making these decisions it’s imperative that patients feel heard and that communication take place between the parents and medical providers (gastroenterologist, maternal fetal medicine, and OBGYN). Knowledge is power and educating yourself going into these conversations and before and during pregnancy can make you feel more empowered in your decisions.
The power of the placenta
There were placentalogists at the workshop—yes, those exist!! And it was amazing to learn how dynamic the placenta is and how it changes throughout pregnancy. The placenta is not just a conduit, its function changes across gestation and with fetal sex and medical condition. It serves as the endocrine function, lungs, pituitary, drug processing center, neuro connections, and growth factors for the baby…to name a few.
For instance, according to this study, there are differing levels of placental chemokines and cytokines and even reduction of placental antibody transfer in male placentas.
Once the placenta is impacted it effects the fetus. There was also discussion about how Inflammatory Bowel Disease impacts placenta—and the possibility of looking at the placenta of an IBD women at delivery to compare them to women without the disease. Even when a woman has well-controlled disease or is in remission, it’s believed our placentas may appear differently at delivery due to the inflammatory nature of our disease. I joked during on one of the speaking panels that I would have gladly given all my placentas to research upon delivery! It’s win-win for researchers and patients alike to do so.
Medication safety in pregnancy
There was also discussion about the importance of developing medications that are safer in pregnancy, much like children’s medications are created with a different formulation.
Prednisone causes minimal fetal exposure. Solumedrol at infusions is fine, and it’s ok to breastfeed on steroids, but high dose daily oral steroid can cause cleft palate and cleft lip.
Azathioprine has also been found to have no impact on breastfeeding, babies born to moms on Azathioprine have normal development and they do not have increased susceptibility to infection.
A graph outlined a study that looked at 107 pregnant women with IBD on Infliximab/Adalimumab:
Detectable anti-TNF levels after birth:
3 months of age—94%
6 months of age—23%
9 months of age—7%
12 months of age—3%
This illustrates why babies exposed to anti-TNF after believed to be immunocompromised until 6 months of age.
Vaccine response and impact of immunosuppressive medications
It is believed that women on immunomodulating medication who get the TDAP vaccination in pregnancy have the same immune response as healthy controls and that the baby receives the same benefits.
The recommendation for Rotavirus (which is the only live vaccine given the first 6 months of a baby’s life), is now to give this vaccine to babies. This updated guidance also applies even when babies are exposed to anti-TNF or immunosuppressive medications in pregnancy.
There’s no difference in vaccine response for babies across different biologics.
Limiting the burden on mom and baby in pregnancy and postpartum studies
Once babies are born and they are part of research studies to measure how their exposure in utero impacts or does not impact their future health, there’s often a burden on the mother about following up. As an IBD mom myself, I wasn’t big on having my babies get blood draws for medical studies—but that data is paramount in helping further that research. And knowing what I know now, I wish I would have been more willing to do so.
So how can studies ease this burden and stress on families?
This can be done by having well-trained phlebotomists who have experience working with children and using techniques to optimize venipuncture success to limit discomfort and pain. By timing blood draws for research at the same time of doctor’s appointments, it reduces the number of needle sticks and blood draws.
Dr. Mahadevan’s Presentation at the workshop
One of my favorite presentations was given by Dr. Uma Mahadevan. She is the key investigator of the PIANO (Pregnancy Inflammatory bowel disease and Neonatal Outcomes), and a well-respected gastroenterologist at UCSF. PIANO started in 2007 and looks at the safety of IBD medications on the pregnancy and short-and-long term outcomes of children. My youngest son is part of PIANO. We participated throughout pregnancy, provided cord blood from delivery, as well as blood draws. I just submitted his 3-year forms online.
I recorded Dr. Mahadevan’s presentation and have transcribed everything she said below so you could hear her expertise firsthand:
“Women of childbearing age—women of reproductive potential are not given JAK inhibitors—even though it may be the most effective medication for them. This is a result of fear—that maybe they’ll get pregnant and maybe there will be some harm. Medications with well-established safety records like anti-TNFs are discontinued in pregnancy now—68% of women who go off their anti-TNF did so from the advice for their rheumatologist, so these are the doctors telling them to do this.
What’s the importance of treating immune mediated disease in pregnancy?
Disease activity is the biggest driver of adverse outcomes in pregnancy. Women with IBD compared to general population have an increased risk of spontaneous abortion, pre-term birth, small for gestational age, hypertensive disorders of pregnancy including preeclampsia , post-partum hemorrhage, and 44% rate of C-section, most of them elective out of fear of disease.
Stopping the biologic which again is out of fear—you’re on a biologic, it’s stopped in pregnancy, still is in many rheumatology and psoriasis cases, less so with IBD, but when you stop it…reducing or stopping leads to an increase of disease flare.
Many of my colleagues who are rheumatologists say “oh many with rheumatoid arthritis get better in pregnancy…there is not a single study that shows that. In fact, this study from The National Inpatient Samples shows women with rheumatoid arthritis were more likely to develop complications of pregnancy both during pregnancy, but also in post-partum and in their neonates.
The American College of Rheumatology conditionally recommended continuing anti-TNF during pregnancy despite the available safety data and the voting panel agreed that if the patient’s disease is under control these medicines can be discontinued. This is happening now.
In this article from a prospective registry from Sweden and Denmark that looked at 1700 patients with RA, there was increase in pre-term birth and small for gestational age in RA compared to the general population and that odds ratio increased to three-fold with active disease.
So, there is data that it increases harm in not just IBD but RA as well. We know there’s a strong role for inflammation in pregnancy and in pregnancy outcomes. So, the significant increase in pregnancy and neonatal complications is closely linked to disease activity and inflammation and stopping these low-risk meds and steroid sparing therapies lead to increased suffering for the mother, and post-partum flares and worst outcomes for the infant.
Healthy mother=Healthy Baby
So, what are some of the study designs and limitations-these have been brought up before. Pregnant women are not included in clinical trials. There’s unmeasured confounding in uncontrolled studies. Disease activity impacts the decision to continue or discontinue therapy. It’s not random. The choice of therapy is not random it is linked to their disease severity and what they have.
If you have a series of 100 patients or 1000 patients or 10,000 patients, you may not pick up the signal. The types of studies that are used for the most part are large data sets, so birds eye view and the highest quality study are large population studies from countries in Scandinavia usually where they have longitudinal assessment, parent-child linkage, and a good assessment of diagnosis in pregnancy outcomes. However, these are limited by a fair assessment of medication because they can only measure prescription and not whether the patient is actually taking the medicine. At a very poor assessment of disease activity and very granular data.
People are more likely to report a complication than a healthy pregnancy—incomplete info.
Let me tell you about PIANO—this is a prospective national registry of pregnant women with IBD started in 2007. PIANO divides people into four groups:
The unexposed—which could include people on steroids, 5 ASAS, antibiotics.
We define exposure as anytime within 3 months of conception through pregnancy. We compare the offspring of women exposed to a medication to offspring of women with IBD who have not been exposed. We looked at multiple different outcomes including pregnancy and neonatal outcomes , we administered questionnaires each trimester of pregnancy, three times in the first year of birth and then annually and we continue to follow these patients out to age 18.
So, here’s some of the data that has been published:
Corticosteroids –I often hear from providers, “oh I’ll just stop their medication and if they flare, we’ll give them steroids.” This actually leads to increase rates of pre-term birth, low birth weight, and NICU admission. Of course, the use of steroids is mostly tied to disease activity. It’s hard to separate the two. But the whole point is that you don’t want disease activity, you don’t want steroid use, you want them to be on a steroid sparring effective therapy.
The primary results of PIANO were published in 2021 in Gastro. We looked at 1,400 IBD pregnancies, 379 were not on drugs, 242 were on thiopurine, 642 were on biologics (Primarily anti-TNF), and 227 were on both biologic and thiopurines so about 1,000 biologic exposed pregnancies. We found no increase in birth defects, spontaneous abortion, preterm birth, low birth weight, or infections in the first year of life. We saw an increase in spontaneous abortion with disease activity and we used the Ages and Stages questionnaires to look at developmental milestones and saw no reduction.
We measured placental transfer and we measured maternal and cord blood for inflammation on day of birth. The highest transfer was with infliximab—the lowest was certolizumab, which doesn’t have the FC portion. Vedolizumab had a lower level in the infant than the mother. When this data first came out the first reaction was – “oh we should stop the biologic early”…so in Europe they have more of a glass is half empty look at medications in pregnancy…US tends to be glass is half full. So, they decided to stop at 22 weeks and that was in their official guidance. And it was not until 2 years ago that that was changed to match US recommendations because their own data showed an increase in disease activity and worse outcomes with doing that.
The concern was if you have this placental transfer, if you have therapeutic drug levels in the infant for several months after birth, do they have higher rates of infection? And we showed in PIANO there is no increase in infection at 4 months of age and at 1 year and we looked at if infection rates were relative to the level of drug in the infant at the time of birth, and there was no association to drug level at birth and recent infection.
So based on that now, we don’t stop the biologic at all during pregnancy, we continue it throughout. A systematic review and meta-analysis looking at 8,000 women with IBD who were exposed to biologics showed no increase in infant infections, antibiotic—- showing that biologics do not cause harm.
This data from Antoine Meyer who uses a French patient sample looked at women on anti-TNF and thiopurines and showed no increase in the risk of early life malignancy in children.
We ask about infection—we ask about immune suppression—we ask about malignancy and so far in these 3700 thiopurines and 3400 anti-TNFs from 3 years of age going out to 11 years of age, no increase. Very reassuring data.
PIANO looks at developmental milestones—out to 12 months and up to 4 years—shows no decline, we actually showed patients on TNF had statistically superior developmental milestones in every category compared to the national average and even within PIANO—not to say that TNF’s make your kid smarter…but the whole idea of controlling inflammation is what allows these kids to lay down their neural pathways.
What about the newer biologics?
Ustekinumab and Vedolizumab—again showing no increase in harm for both pregnancy and infant outcomes.
Antoine Meyer again from the French database looked at 398 vedolizumab pregnancies, 464 Ustekinumab pregnancies…again, no increase in harm for all these important outcomes.
It’s not just congenital malformations, what else can happen with these medications?
We’re working with Susan Fisher who is a placental scientist at UCSF, a question was raised about Vedolizumab inhibits alpha 4 beta 7, which can inhibit MAdCAM, which is involved in the process of plasmatation—so if you inhibit MAdCAM are you going to have issues in plasmatation. This was just a pilot study. The first one here the patient also had pulmonary hypertension—this is a normal placental at birth…you can see how this looks distinctly abnormal. The second patient was born 39 weeks, mother was completely healthy with her UC had no other issues during pregnancy. Compared to normal placenta…so are there other things we are missing here?
We are conducting a larger study now with multiple biologics the question is it’s not the Vedolizumab is my hypothesis, it’s more a result of inflammation, having IBD…but it will be interesting to see what these placentas look like when we finish. But maybe this is why these patients have higher rates of preeclampsia, higher rates of hypertensive disorders in pregnancy, and preterm birth. It may be related to the impact of inflammation on the placenta.
Small molecules—I feel very comfortable when a new biologic comes out to continue in pregnancy, I feel reassured by the minimal to lack of transfer in the first 14-16 weeks of gestation, with small molecules—they will transfer and Tofacitinib showed teratogenicity at super therapeutic doses, Upadacitinib showed teratogenicity at the doses we use in humans at 30 mg daily—so that does raise concern. There is now some data, again from clinical programs—no increase in birth defects, in pregnancy loss.
Same for –in press—looking at Upadacitinib …128 maternal exposed pregnancies, 80 of which were in clinical trials…similar rates of live births, spontaneous abortion, compared to what is expected.
What about breastmilk? In PIANO, we do collect samples and found the amount of transfer was really miniscule. But all biologics had transfer—we found no increase rates of infection or impact on developmental milestones with patients who were breastfed while the mother was on an immunomodulator.
We talked about vaccines—if these patients had detectable level of biologics—the first 6 months of life will they have normal response to vaccines? We looked at Tetanus — and found the rates of response were similar to infants of mothers who were not exposed to biologics…that was reassuring. We had 40 inadvertent Rotavirus exposures in our TNF babies, they did just fine. This has also been shown in European data as well. And I want to make sure you are all aware of the study from Lancet looking at Rotavirus vaccine—this was a prospective study looking at infants exposed to biologics, they gave 168 biologic exposed infants Rotavirus vaccine—can only be given the first 3-4 months of life, after 6 months it’s not given—so if you say no in the first 6 months, baby never gets it. They found no harm—at this point, we are letting patients on TNF get Rotavirus vaccine, you can argue the US and most areas because of herd immunity, Rotavirus may not be that important, but in other parts of the world it is—and it’s fine to give to patients exposed.
BCG vaccine is different—especially in an anti-TNF exposed baby, it does have a higher rate of TB, having to do with mechanism. There was one death in a European study given vaccine at 1 month of age. BCG can be given after 6 months of age. So Rotavirus is fine within 6 months, but BCG is still recommended after 6 months.
MMR in high-risk populations can be given at 6 months—why did the Europeans, Asians, and Americans have such different guidelines? This May (2024) we all got together for the Global Consensus Conference to create one standard for pregnant women globally and to help spread the word.
Our recommendations are to continue 5ASA, continue sulfasalazine, continue steroids when necessary, stop methotrexate, and continue thiopurine, continue anti-TNF therapy. The US and Europe agree we will not be stopping TNF early, we will continue it on schedule. We’ll continue vedolizumab and ustekinumabon on schedule, and it’s ok to start these medications in the middle of pregnancy.
Biosimilars have equal safety as originator. The Europeans didn’t understand why we wanted to include this, but this is a common question that comes up in the US. We consider biosimilars safety to be equal to the originator drug.
IL-23 therapies… even though not well studied, we feel based on mechanism they can be continued.
Small molecules should be discontinued—but particularly for the JAKS though, unless there is no effective alternative, they can stay on them. I have had patients where they have to stay on Tofacitinib and Upadacitinib because there was nothing else that worked for them.
Inactive vaccines should be given on schedule. we suggest live rotavirus can be given to children exposed to anti-TNF and recommend BCG be avoided in the first six months.
Final thoughts
A recording of this two-day FDA workshop will be available online in the next two weeks. I will share the link as soon as it becomes available. on my Instagram (natalieannhayden). There were fantastic discussions and as an IBD mom who has gone through pregnancies while on a biologic I am grateful for the consideration and the research that’s going on to help couples feel more confident and at ease about bringing life into this world while juggling complicated health conditions. The conversations and presentations at the workshop were extremely complex, I did my best to translate the information, so the patient community has a better grasp of where we stand about IBD pregnancy research.
If you have IBD and are planning to be a mom or if you are currently pregnant, please consider joining the PIANO study and being a part of this life-changing research for our community.
One of the main challenges and worries women face when it comes to pregnancy and IBD is feeling comfortable and confident staying on their medication. The first-ever Global Consensus Conference on Pregnancy and IBD was held during Digestive Disease Week (May 2024) and part of the discussion focused on the latest recommendations for medication during pregnancy and lactation. Last week on Lights, Camera, Crohn’s we covered the global guidance regarding pre-conception counseling and family planning.
Hear from the co-chairs of the Global Consensus Conference and esteemed gastroenterologists, Dr. Uma Mahadevan and Dr. Millie Long about what they want the IBD community to know about medication during pregnancy and postpartum.
The latest recommendations for IBD women
All biologics can be continued through pregnancy and lactation
5ASA can be continued
Thiopurines can be continued, but monitor liver enzymes for intrahepatic cholestasis of pregnancy
S1P agents and JAK inhibitors should be avoided in pregnancy unless there is no other viable alternative
Biosimilars are equally safe to originator drugs (biologics) in pregnancy
Wound healing after C-section/episiotomy: Thiopurines delayed wound healing with episiotomy, but there’s no impact of biologics on wound healing with C-section, tear, episiotomy
These recommendations were voted on and determined by more than 50 medical providers and IBD patient advocates from around the world. The hope is that this guidance will leave couples feeling empowered and more comfortable in their decision to stay on medications that are deemed low risk.
“We have learned that there are many different practice patterns in various locations globally regarding treating women with IBD during pregnancy. The goal of this Global Consensus was to have a consistent, evidence-based framework for management of pregnant women with IBD that will improve the quality of care globally. Most importantly, treating inflammation and continuing appropriate medications (such as biologics) improves outcomes for both mom and baby,” said Dr. Millie Long.
When I was pregnant with my children, I trusted what my care team (GI, OB, and Maternal Fetal Medicine doctors) told me regarding Humira and the risk versus benefit of staying on my medication through pregnancy and after. I credit my medication for keeping my Crohn’s under control while I carried my babies and after I brought them into this world. But I’m going to be honest—when you are 36 weeks pregnant and you feel the baby kicking and moving as you’re about to do your injection, it can feel emotional. At the same time, I always told myself I was doing what was best for me and for them. Now that my kids are 7, 5, and almost 3 (all perfectly healthy), I am reminded every day that I made the right choice for our family.
Handling the hesitations
Dr. Mahadevan says when patients come to her worried about staying on their medication while they are pregnant, she discusses the “very clear data” that shows disease activity is the strongest predictor of pregnancy complications.
“This includes having difficulty conceiving, higher miscarriage rates, higher complications of pregnancy, including pre-term birth. Pre-term birth has a strong correlation with reduced socioeconomic status and other issues later in life. Plus, if women are so sick and worn out by their IBD, they aren’t able to enjoy their new baby and struggle to take care of their child as well as they would like to. For medications like monoclonal antibody, where there is good safety data, it really makes sense to continue.”
“Women should stay on biologics during pregnancy without any alteration when they are pregnant. This reduces the risk of flare during and post pregnancy for the mom and improves outcomes for the baby. The strongest predictor of pre-term delivery (and the complications arising from this), is active inflammation,” said Dr. Long.
Clinical trials in pregnancy and drug safety rely on observational data. There are no randomized trials where one person is chosen to get therapy, and another is not.
“This is where the PIANO study and other such prospective (where we follow patients before we know the outcome) registries are so important. We can collect data quickly… as soon as a medication is approved for use. We also get data from large population datasets from countries such as France, where all patients are registered, and their outcomes can be collected. This takes longer but will have much larger numbers,” explained Dr. Mahadevan.
All three of my kids were part of research studies while in utero and after. My youngest who turns three in July was part of the PIANO study. I can’t say enough about the importance of contributing to research and helping to pave the way for future IBD families. We have the guidance we have today because of all the moms who took it upon themselves to be a part of studies like PIANO.
Biosimilars in pregnancy
As more and more patients are switched from a biologic to a biosimilar, there’s a great deal of interest in how this impacts family planning and pregnancy.
A total of 89 pregnant women with IBD enrolled in PIANO on Infliximab were included as part of a study presented at Digestive Disease Week entitled, “Use of Biosimilars to Infliximab During Pregnancy in Women with Inflammatory Bowel Disease: Data from the PIANO study” that Dr. Long and Dr. Mahadevan were a part of.
In the study, 76 women were on the originator drug (Infliximab/Remicade), while 13 women were on an Infliximab biosimilar.
“Though this study is small, Europeans noted that they did not differentiate between biosimilar and originator in their studies. There were no difference in clinical characteristics or significant differences in any pregnancy complications between the two groups. Developmental milestones were assessed at 12 months, with no differences in communication, fine motor, gross motor, personal/social interaction, or problem solving between groups,” said Dr. Mahadevan.
This data and ongoing research can reassure mothers with IBD on biosimilar IFX who wish to pursue pregnancy.
Avoiding S1P agents and JAK inhibitors in pregnancy
For those who don’t know—S1P agents and JAK inhibitors include: Ozanimod (Zeposia), Tofacitinib (Xeljanz) and Upadacitinib (Rinvoq).
If you’re currently taking one of these medications and finally have your IBD under control, it can be daunting to know what to do next for family planning.
“It is a case-by-case situation .In general, we would like to avoid these agents as, unlike with biologics which are antibodies, these agents are pills and cross the placenta during the first trimester during a key time in the baby’s development,” said Dr. Mahadevan. “Animal studies have shown harm with supratherapeutic (higher than human doses) levels of drug. Upadacitinib (Rinvoq) had birth defects in animals even at human doses. For S1Ps, usually there is another effective medicine patients can try. An exception may be if they also have multiple sclerosis as S1Ps are used to treat both conditions. For jak inhibitors, they are often the only effective therapy for a patient. We will discuss the risks, the benefits, and the options – using a surrogate, etc.”
Lactation considerations
The benefits of breastfeeding are similar in IBD and non-IBD moms.
“We do not have robust data that breastfeeding will specifically reduce the risk of IBD in offspring, but there are many studies in the general population that demonstrate that breastfeeding is beneficial to infants. The choice to breastfeed is an individual one, and it is important to support each family’s decision,” said Dr. Long.
Breastfeeding research is more challenging than pregnancy studies, as this is not collected in medical records or large databases.
“Breastfeeding research is data from registries like PIANO and individual studies from different IBD centers, which measure transfer in breastmilk and outcomes,” said Dr. Mahadevan.
She went on to say that breastfeeding is allowed on thiopurines, and there should be low to no risk to the infant.
“Ideally, if the mother can wait four hours, there is no drug transferred, but even earlier the amount that is transferred is very low,” explained Dr. Mahadevan.
As an IBD mom who fed each of my babies differently, I want to reiterate that whether you choose to breastfeed or not is a personal decision and you are not less than or a failure if you need to supplement or formula feed. Juggling chronic illness, postpartum, and motherhood is a lot. Give yourself grace and trust your child will thrive no matter how they are fed.
My oldest was only breastfed for three days because I wasn’t well-versed about the data regarding biologics and breastfeeding and because I was nervous about flaring and not being able to feed my baby. I breastfed my middle child for 6 months while supplementing, and my youngest was exclusively breastfed 14 months—all while on Humira. Your journey and your experience are personal to you. Try not to allow outside or societal pressure to contribute to your guilt as an IBD mom.
Gaps and strides in IBD research Dr. Long says we need more data on the safety and efficacy of novel small molecules during pregnancy.
“This includes medications like tofacitinib, Upadacitinib, Etrasimod and ozanimod. This is why registries like PIANO are so important, to capture this information and inform patients and providers alike. Some of the strides being made in IBD pregnancy research include the effectiveness of pre-conception counseling, novel assessments of disease activity during pregnancy (such as intestinal ultrasound), data on novel biologics during pregnancy and lactation (including newly approved therapies such as Risankizumab or Mirikizumab) and data specifically on biosimilars. Through this data and the Consensus recommendations, we can improve pregnancy outcomes for many women with IBD,” said Dr. Long.
The overall hope is that the Global Consensus Conference recommendations will provide women with IBD all over the world with consistent and evidence-based care prior to, during, and post pregnancy.
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