The Patient Experience: Making the Leap from Pediatric-to-Adult IBD care

Moving away for school. A future career. Relationships. Discovering your identity. Switching from a pediatric IBD care team to adult providers. All while living with a chronic illness. This is the stark reality for young adults living with Crohn’s disease and ulcerative colitis. Juggling all these major life milestones and having to get acclimated to new physicians while taking the lead on disease management is often met with anxiety and worry from young patients, their parents, and caregivers. IBD is a family disease. Even if only one person in the household personally lives with the issue, the disease impacts each person.

This week on Lights, Camera, Crohn’s we hear from patients and caregivers who have lived through the experience and from pediatric GI’s about how best families can be supported through the changes to make them as seamless as possible for everyone involved.

Input from those who have made the switch

Aging out of pediatric doctors can be a stressful time for everyone involved. Let’s start with input from those with IBD who have made the switch along with what some parents and caregivers had to say.

  • Start researching doctors early. Do your homework and see what insurance providers accept and what hospitals they are affiliated with.
  • Ask your current pediatric doctors for recommendations/referrals.
  • Before the first visit make sure the adult GI has received copies of medical records.
  • Have healthcare proxy and power of attorney papers on file.
    • “I just turned 20, but I’m still in pediatrics and plan on staying until I graduate from college, as that is the norm at my hospital. However, as an adult in peds, I found it important to have healthcare proxy and power of attorney papers on file so my mom can still help me and if something were to happen like while I’m away at school she is able to get information. I broke my arm this past fall and my body went into such shock that I couldn’t give the hospital any information. My friends were with me and contacted my mom, but because I was 19, the hospital couldn’t even confirm to her that I was in the building. This was a wake-up call. We started thinking about, “what if this was my IBD?” and decided it was necessary to have the papers on file just in case. I still ask my mom to be involved in my care, but we both have the understanding that I have the final say.”- Anna

Navigating the switch through college

Heidi was diagnosed with Crohn’s when she was 9. She’s now 41. When she reflects on the transition from a pediatric doctor to one who treats adults, she recalls the process being fairly simple and a change she welcomed with open arms.

“The best thing was being talked to directly and my opinions mattered more in my later teenage years with the new doctor. Of course, my parents had my best interests at heart, but appointments were so frustrating as a young girl. Another reason for the seamless transition was that my new doctors were amazing. I switched at 18 and then again at 22 when I graduated college and moved away from home. My care team listened to me and saved my life. I know I’m lucky to have found such a wonderful team of doctors.”

Katie wishes there had been a support group (even online) for teenagers back when she was phased into an adult GI. She says when she was diagnosed with IBD at age 15, she often felt uncomfortable discussing her symptoms and didn’t feel her pediatric GI was that great with kids.

“I felt detached from my GI until I was in my 20s and had the confidence to advocate for myself. I was so lost and refused to tell classmates what was wrong with me for fear of being made fun of. I ended up missing so much school I decided to drop out, get my GED, and go straight to college. It was a terrible time to be honest.”

The difference in pediatric vs. adult care

“The transition happened quite fast as I was being referred to an adult surgeon for my complications that the pediatric team were not experienced or educated enough to treat for Crohn’s. I was thrown in the water with no guidance when I started seeing physicians who treated adults with Crohn’s. The pediatric GI team would dumb some things down for me and make my problems not seem “as bad.” As soon as complications started arising, they threw the towel in and basically told me they couldn’t help me anymore and would be better off seeing a care team with more experience with my symptoms and complications.”-Chrissy

Natasha experienced the transition about 13 years ago. Her pediatric team helped her choose an adult GI. And the guidance didn’t stop there.

“My pediatric GI told me who she wanted for me and then went with me to interview the doctors in the adult team. Once I chose, my pediatric GI attended every appointment with me until we all agreed I was ready to move into the next step of my care, which luckily was quickly. And the two doctors stayed in communication. My advice—be open with your doctor.”

Natasha recommends asking yourself the following questions to help streamline the process and make it less nerve-wracking.

  • What are you looking for in your next step of care?
  • What are you looking for during the transition process?
  • What is important to you in a physician?

Do your own research

“I had an AMAZING pediatric GI when I switched, and I just went with who she recommended. Looking back, I wish I did my research because he is not who I would have chosen for myself. I would recommend doing your own research and make sure whoever you find is willing to work with you and thoroughly go through your medical history and all your results. Too many doctors seem to just think they know everything, but we know our bodies best and need to have a medical team who lets us advocate for ourselves.”-Danielle

Jennie has lived with IBD for nearly 20 years. She has a PhD, works in IBD care, and recognizes she has the privilege of a strong support network and insurance. As an IBD psychologist she recognizes how difficult the system and transition can be for everyone involved.

“I was diagnosed with IBD at 12 and transitioned to adult care around age 18. I was extremely sick at the time and ended up having a proctocolectomy within months of transitioning. I think the biggest things for me were the notable shift in culture between the peds and adult world, and the insurance pieces. It’s so much for kids and families. Lastly. I’ve noticed the transition is nuanced for my parents who were so good at being my advocates, they will still offer to call the doctor if I tell them I am not feeling well, and they have a tough time not having the same significant role they did when I was younger.”

Allie was diagnosed with Crohn’s disease when she was 12. Her mom attended all her appointments until she turned 18, and only stopped going then because she was out of state for college and seeing a pediatric GI there until she turned 22. Allie’s mom kept a medical binder of all her procedures, lab results, and details about her patient journey. She says when she phased out of pediatrics and started taking matters into her own hands, she found the binder her mom made to be beneficial—Allie found herself referring to it when she couldn’t remember everything.

“What helped the transition the most was going to appointments on my own when I turned 18. I felt more prepared to speak for myself when I switched to an adult GI.”

Allie’s mom also inspired her to ask the tough questions. After witnessing how her mom spoke up to doctors it empowered her to speak up and stop minimizing her struggles. By watching how her mom handled appointments, it inspired Allie to write down all her questions and concerns before doctor appointments, so she doesn’t forget anything.

“My mom asked me what fights I wanted her to fight for me and what I wanted to do myself. She guided me on what I might need to ask about when I had no clue—even as an adult she still offers to help call insurance companies to fight authorization battles. She gave me space to live my life when I turned 18. She worried, but she never hounded me for updates (are you taking your medication?, how are you feeling? Are you eating ok?”…but she always conveyed support (both my parents did) when I needed it most she showed up.”

Sari recommends young adults with IBD to ease into taking control of their care as early as possible.

“Things like refilling your own meds, scheduling your own appointments, and driving yourself to appointments goes a long way when it comes to learning how to stay organized and advocate for yourself. You don’t want to be doing all those things for the first time when you go to college or a start a new job—too many scary or unknown things at once!”

Check out what pediatric GI’s have to say about bridging the gap and ensure continuation of care.

Dr. Sandra Kim, MD, Associate Professor of Pediatrics, Director, Inflammatory Bowel Disease Center, UPMC Children’s Hospital of Pittsburgh, says, “Transition is the preparation process while the young adult/teens are still under the care of the pediatric team. Transfer of care is the actual “handoff” when the young adult moves from the pediatric GI team to the adult GI providers. Teens want independence but struggle with disease knowledge and self-management skills. Therefore, the pediatric GI team needs to help the teen (and the family, too!) by being active listeners, communicators, and educators. The healthcare team also should utilize things like transition tools.”

Dr. Kim went on to say that GI doctors need to assess how teens are doing on the road to greater independence and that shared decision-making helps build partnerships between adult and pediatric GI providers.

For the adult GI team:

  • Collaborate with the peds team in the initial stages of care transfer.
  • Anticipate existing gaps of knowledge and self – management skills
  • Prepare for more time during appointments for questions, additional education, and working with the family. Parents need help during this time of care transfer, too!
Woman patient signing medical documents discussing medication treatment with african american practitioner in hospital office during clinical consultation. Doctor physician explaining disease symptoms

Dr. Jonathan D. Moses, Assistant Professor of Pediatrics, Director, Pediatric Inflammatory Bowel Disease Program, UH Rainbow Babies and Children’s Hospital, explained how his hospital has a multidisciplinary pediatric IBD team that engages patients in a Health Maintenance Education Clinic as early as 11 years old.

“This allows them to build up the self-management skills needed for a successful transition to adult GI, when they are ready. In lieu of this resource, parents can engage their health care providers about ways to get their child more involved in their care and provide them with the autonomy, and support, to take over aspects of their care over a period of time.”

Dr. Hilary Michel, MD, Assistant Professor of Clinical Pediatrics, Nationwide Children’s Hospital, says a successful transition from pediatric to adult care requires that young folks have developed the knowledge and skills needed to understand and manage their disease independently.

“This knowledge and skill is not gained overnight, and ideally should be obtained gradually. Transfer to adult care should be planned in advance, when a patient is feeling well and has a good grasp on their disease management, so there are no gaps between peds and adult care. Parents and families can help the process by allowing teens to speak with their healthcare providers alone, gradually share care responsibilities, encourage them to learn about their disease, and highlight their successes.”

How this works in real time:

  • Patients can listen and participate in their visits.
  • Set goals with your healthcare team and work toward them, ask questions and share your opinions.
  • Healthcare teams can help by providing a non-judgmental space, listening attentively, encouraging young people’s success, engaging patients in decisions, checking for understanding, getting to know patients as people (talk about school, friends, activities), and connecting patients with resources

Dr. Whitney Marie Sunseri, MD, Pediatric Gastroenterologist, Assistant Professor of Pediatrics, UPMC Children’s Hospital of Pittsburgh, says “I always encourage a step-wise approach to transitioning to the adult world. I encourage patients to know their diagnosis, what medications they take and when, to recall their last scopes, and to be able to report all of their symptoms without the assistance of their parents. Then as they get older, and closer to the time of transition, I encourage them to look into different adult doctors. I give recommendations as well.”

Dr. Sunseri advises caregivers and patients to be proactive and look at reviews of doctors and who is in their insurance network. She says the most important visit is the one where patients follow up with her after their first adult visit to make sure it was a good fit and that they are in good hands.

“It’s bittersweet watching these children grow in so many ways and head off into the hands of another provider. Your heart swells with pride and breaks at the same time.”

Resources and Communities of Support

Sneha was diagnosed with Crohn’s at age six. She’s now 23 and still figuring out what her future will look like with IBD. As she grew up, she couldn’t find a community of young adults. This inspired her to create Generation Patient and the Crohn’s and Colitis Young Adults Network.

“Peer support during this transition is critical, so we host seven virtual community meetings. We have hosted over 250 of these peer support meetings over the last two years. I think peer support should be seen as essential during this transition period and it has been the best thing to come out of living with IBD.”

Generation Patient: Instagram–@generationpatient

CCYN: Instagram–@ccyanetwork

Join the American College of Gastroenterology Thursday, May 4, 2022 at Noon and 8 pm ET for a discussion about “Empowering Patients Through the Transition of Care in IBD”. Click here to register.

ImproveCareNow (Instagram: @ImproveCareNow)

The Circle of Care Guidebook for Caregivers of Children and Adolescents Managing Crohn’s Disease

Crohn’s and Colitis Foundation Youth + Parent Resources

National Council of College Leaders

Transitioning GI Patients from Pediatric to Adult Care

Transitioning from Pediatric to Adult IBD (This includes a helpful breakdown of ages and a checklists for independence, health, and daily activities)

IBD Support Foundation

Transitioning a Patient With IBD from Pediatric to Adult Care

The Patient Experience: Puberty and IBD

Whether you are a parent or not it’s heartbreaking to imagine how it would feel if you found out your child (no matter their age) was diagnosed with a chronic illness like inflammatory bowel disease. Of the more than six million people in the world diagnosed with Crohn’s and ulcerative colitis, approximately 25% of patients are diagnosed during childhood and adolescence, most of which are going through puberty. Impaired growth, pubertal delay, and low bone density are all common in children and teens with IBD. They can occur at diagnosis or at any time during a patient’s IBD journey.

As an IBD mom of three, who was not diagnosed until I was 21 years old, I personally don’t have the experience or perspective to share what it’s like to grow up with IBD or have a child diagnosed with it, so I tapped into several caregivers in our community, along with four leading pediatric gastroenterologists for input.

My hope is this article will serve as a helpful resource as you navigate the challenging waters of puberty with your loved one. Teen years are difficult enough without a chronic disease, taking a close look at how this impacts a young adult physically, emotionally, and mentally is something that deserves much more attention than a blog article.

Concerns from patients and caregivers

Before we get into the medical input, I want to share some of the messages I received this week from young patients and their caregivers so you can see firsthand how complicated this period of life is for everyone involved.

I’m 14 years old. I was diagnosed with Crohn’s when I was 12, which marked an influential time in my life. It can be hard to cope with being diagnosed and having a chronic illness at that age. That year leading to my Bar Mitzvah, a cultural rights of passage from boyhood to manhood, was really challenging for me. At a time when changes are going on and puberty takes its course, learning to trust your body and that it is working is key. Rather than trusting my body, I had a lot trust issues. If my body could turn itself to work against me in my GI system, what’s to say it wouldn’t turn on me other ways? I am especially worried about my reproductive system. Since I was a little boy, I always knew I wanted to be a father when I grew up. Having kids and being a family man has always been my highest purpose in life. Since my Crohn’s diagnosis, I’ve felt anxious and worried about whether my Crohn’s or my body will stop me from fulfilling that dream.”

“I often worry about whether my son’s hormones will put him into a flare and wonder what the best way to approach the school about his Crohn’s is.”

“My biggest puberty concern is delayed growth or slowed growth and flares. I’ve heard a lot about puberty hormones really causing issues. Is there truth to this?”

“Will my almost 15-year-old son start puberty once his treatment kicks in or will he always look like a 12-year-old child?”

“My 15-year-old lost more than 15 pounds in the last year, we’ve checked all kinds of things, but can’t figure it out. He’s on renflexis (generic Remicade) and his colonoscopy came back clean. He gets full easily and deals with chronic constipation. I hope his IBD doesn’t stunt his growth.”

“The anxiety of managing IBD while combining that with the developmentally normal anxieties of the adolescent years can result in mental health issues that are hard to pinpoint. Body image issues that are normal as their bodies change, mixing with body image and food-related issues associated with IBD (good foods and bad foods, overly focusing on diet, etc.) which can lead into worrisome territory like disordered eating and worse. As children separate from their parents more with each passing year (which is normal), it becomes harder to monitor IBD symptoms and disease progression as a parent. As someone who has always been in the driver’s seat about IBD, this is a scary shift and I worry some symptoms will go unnoticed and become exacerbated.”

“That puberty will stop growth—growth has been severely impacted by Crohn’s before diagnosis and it did—hitting puberty early meant growth stopped and she only reached 4’9”/4’10”. Her periods also add to existing fatigue levels.”

“I worry about medication not working like it used to due to so much change in the body. I also worry about how she may feel about her image comparing herself to others at that age with so many scars or if she ever needs to have an ostomy bag. I worry her IBD will affect her cycles or make them more painful.”

“That my son will go into a flare requiring heavy intervention that goes far beyond our comfort zone, but we’ll feel trapped so he’s able to grow at the right time.”

“My 13-year-old son was diagnosed with Crohn’s a little over a year ago. He is doing ok now and on Humira bi-weekly. I’m mostly concerned about his growth, as he is small for his age. He has gained about 20 pounds in the last year, but he was malnourished as COVID made it difficult to get his diagnosis. Hoping he stays on track and continues growing and that his growth potential isn’t adversely affected by his IBD.”

“As a kid who went through being on high dose steroids while going through puberty, bless my mother!”

“Delayed puberty is a big thing. Also, how, and when is it appropriate to start transitioning responsibly for ultimate transfer of care. Mental health is often a concern for adolescents (anxiety/depression).”

“Flares. Many parents report puberty as being a challenging time for IBD. Imagine all the normal teen/puberty hormonal issues and then add IBD (and I say this as a lucky parent with our teens). I think every parent that makes it out alive should get a very long vacation. The #1 thing I hear from parents of kids with IBD is: “my heart breaks every single day”. Whether in remission or not, the disease is a persistent and heavy burden on patients and families. With all the noise, it’s important not to lose sight of this fact.”

“I was diagnosed with ulcerative colitis at age 13 and it all happened very quickly. I was in eighth grade – my body changed almost immediately after being put on prednisone. Being an early developer, puberty was a challenge for me. I didn’t look like most other girls in my grade. So when I started getting really bad acne and a swollen (moon) face from the meds, it was the icing on the cake. I remember ninth grade consisted of me coming home from school and crying to my mom because I felt what was happening to me was unfair. I’d have to excuse myself during classes to use the bathroom, so everyone knew what was happening. I was mortified. And although I was an “early bloomer”, I can’t help but wonder if I would have grown a bit more if I hadn’t been diagnosed, put on prednisone off and on for the first 3 years, or started on biologic treatment. There’s always the questions and mystery of what IBD has potentially taken away from me. But living with IBD also resulted in me growing up pretty quickly. I was able to navigate the healthcare system by the time I graduated from high school. I learned to talk about my body and my health – things that I don’t believe my peers could articulate by that time. So it came with some benefits – or at least things that I have been able to turn into positives. My experiences have made me a stronger person. And I’m thankful for that.”

Impaired Growth: Why it happens and what to watch out for

According to Dr. Sabina Ali, MD, Associate Clinical Professor, Director of IBD program, UCSF Benioff Children’s Hospitals, the most common extraintestinal manifestation of IBD in children is impaired growth, particularly in Crohn’s disease and that’s also what she hears from patients and their families when it comes to their greatest concern.

“Growth is a dynamic marker of overall health in children and adolescents, which occurs in 10-30% of cases. Short stature and failure to grow can precede IBD symptoms. It is important to monitor nutrition and growth closely and as this can lead to delayed puberty. Make sure the child is routinely getting height, weight and BMI measured. Growth impairment is more common in males than females with Crohn’s disease. It’s important to get disease in remission.”

Dr. Ali went on to explain that growth issues are more frequently seen in children who have never been in remission or for those who have dealt with flare ups in the pre-pubertal period.

“Pubertal delay may potentially decrease bone mineralization and affect quality of life in children who realize that their sexual maturation is different from their peers.”

Dr. Jonathan D. Moses, Assistant Professor of Pediatrics, Director, Pediatric Inflammatory Bowel Disease Program, UH Rainbow Babies and Children’s Hospital, agrees that remission is essential as a first step to ensure normal bone growth and pubertal development. Most of the time the concerns we hear about puberty and IBD is at the initial diagnosis when parents will note that young women have not started their menstrual cycle yet at the expected age or young men have not started their “growth spurt” yet.

“Growth is a key element of children diagnosed prior to puberty. Our goal is to provide the therapy that will allow them to be in continuous remission and achieve their final adult height and avoid any pubertal delays. If there are any concerns with this, we typically place a referral to the pediatric endocrinologist to help co-manage this.”

According to this University of California San Francisco study, boys are three times more likely than girls to deal with one of the conditions most devastating effects: the failure to grow normally. Researchers were surprised by this finding because the study also found girls had a more severe disease course than boys.

Dr. Ali says that a novel finding is that a high proportion of patients with ulcerative colitis exhibited continued growth, suggesting delayed skeletal maturation is also frequent in ulcerative colitis, contrary to common assumptions. For patients exhibiting continued growth, median final adult height was greater in males with ulcerative colitis than males with Crohn’s disease but did not differ significantly in females with ulcerative colitis, compared with females with Crohn’s disease. This finding supports the growing body of literature that statural growth impairment is more common in males than females with Crohn’s disease.”

Dr. Hilary Michel, MD, Assistant Professor of Clinical Pediatrics, Nationwide Children’s Hospital, explains the importance of monitoring pediatric GI patients’ weight, height, and pubertal development over time. She says measuring weight and height and asking about pubertal development helps make sure each patient is tracking along their growth curves and developing at an appropriate rate.

“In addition to monitoring IBD symptoms and checking labs, stool tests, and scopes, monitoring growth and pubertal development is another way to make sure we are treating IBD inflammation completely. If a patient is not going through normal stages of puberty, or is going through puberty more slowly than expected, it’s a hint that we should check on their IBD disease control! And if their disease is in control, then we need to think of other causes for delayed puberty and get them in to see the right experts to help.”

Dr. Sandra Kim, MD, Associate Professor of Pediatrics, Director, Inflammatory Bowel Disease Center, UPMC Children’s Hospital of Pittsburgh, says along with monitoring growth and nutritional status, it’s important to keep a close eye on emotional state and quality of life.

“It’s important children understand their disease, and for families and the care team to understand where the child is not only medically, but psychologically and developmentally. As a pediatric gastroenterologist, who focuses on the care of children and teens living with IBD, I know I have a unique relationship and responsibility as I watch “my kids” grow up.”

Dr. Kim says, “We see growth impairment in children and teens with Crohn’s much more so than with ulcerative colitis, especially with extensive involvement of the small intestine. Active inflammation in the small intestine can impact an individual’s ability to absorb nutrients. IBD also impacts appetite and can lead to inadequate nutrition.”

According to Dr. Kim, studies have shown up to 80% of children (males>females) have some degree of both weight and growth impairment when their Crohn’s is not controlled. While studies do vary in the range affected, it’s clearly a significant issue.

Medication and the pubescent years

In general all pediatric gastroenterologists try to limit and shorten the exposure of steroids in children.

Dr. Ali says, “Recent inception cohort studies in pediatric IBD have highlighted baseline phenotyping of patients to predict the severity of their disease course and help identify who will benefit the most from early biologic treatment. Biologic therapies have improved outcomes in pediatric IBD, including achieving mucosal healing as well as improved growth and pubertal development.”

Prior to this, the goals of treatment in Crohn’s disease were focused on controlling symptoms, enhancing quality of life, minimizing complications to prevent surgery, and restoring growth in pediatric patients. Evidence has shown that mucosal healing is associated with sustained corticosteroid-free clinical remission, reduced hospitalization, and lower surgery rates. According to Dr. Ali, biologics are the most effective in inducing and maintaining mucosal healing in this patient population.

Dr. Moses explains how biologics are decided upon with young patients.

“The age of the patient, in the context of the biologic era, does not seem to play a significant role at our center. If a child, regardless of age, needs a biologic medication, then we will typically proceed with this after shared decision making with the family. As a rule, for all ages, we work very hard to limit steroid exposure, both by planning out their maintenance therapy right away or using exclusive enteral nutrition (EEN) to induce remission in our patient with Crohn’s disease.”

Dr. Michel says it’s important to get IBD under control quickly since the window to achieve the goal of remission is so small.

“Because of this, growth and pubertal delay can be reasons to start a biologic as first line treatment. If steroids are used, they should be short-term (induction therapy only) to prevent negative impacts on growth and bone health. These patients may also be great candidates for exclusive enteral nutrition to treat their IBD, as it can help heal inflammation and address malnutrition without the side effects of steroids. Involving an experienced dietitian is key!”

While research has shown that disease activity may fluctuate with hormonal shifts (like those that happen with puberty, pregnancy, and even menopause), Dr. Michel says she is not aware of any specific data to connect loss of response to therapy because of puberty.

Puberty gets delayed

For pediatric patients in whom remission has never been achieved or for those who have frequent relapses, puberty is often delayed.

The endocrine-hormonal mechanisms responsible for pubertal delay associated with inflammatory disease are incompletely understood. It is thought to be due to effect by both nutrition and inflammation,” said Dr. Ali.

Delayed puberty or delayed linear growth can be presenting signs of IBD to help clinicians make the diagnosis.

“Once these pre-teens achieve remission, they will begin to progress through puberty again and have improvement in their bone density, if it was low at baseline,” says Dr. Moses.

Dr Michel says, “The best way to ensure normal growth, weight gain, and pubertal development is to make sure their mucosa is healed. It’s also important we address low weight or malnutrition. If we’ve confirmed that IBD inflammation is resolved (through labs, stool tests like calprotectin, and scopes), and that patients are getting the nutrition they need, and we’re still seeing delayed puberty or slow growth or weight gain, this may prompt a referral to an endocrinologist, adolescent medicine doctor, or gynecologist to look for other causes of these problems.”

By adequately treating IBD and achieving mucosal healing, kids have the best chance to grow and develop normally and have healthy bones.

“Inflammation affects hormones important in growth and pubertal development, and delayed pubertal development is closely tied with poor bone health,” explained Dr. Michel. “Active inflammation can also worsen malnutrition and lead to low weight, which can delay puberty. These variables are often closely related; for example, a patient with active IBD may not feel well enough to eat regularly and lose weight or be malnourished. Or they may eat well but not be able to absorb the nutrients from their food. Or they may lose nutrients through stool or vomiting. So, treating inflammation and treating malnutrition are KEY to optimizing outcomes for kids and teens with IBD.”

Causes for the delay in puberty and decreased bone density can be multifactorial.

“Things we consider include nutritional deficiencies (not absorbing enough and/or not getting enough into your body), and the impact of inflammation (though pro-inflammatory cytokines – the “chemicals” produced by activated white blood cells – on sex hormone production, as well as growth hormone),” said Dr. Kim. “Other factors that can specifically impact bone density – decreased physical activity which leads to decreased muscle mass.”

When determining a course of therapy, a child’s quality of life and the impact of active IBD must be taken into consideration.

Dr. Kim explains, “Steroids have a great deal of side effects: external appearance (“moon” facies), psychological (can exacerbate underlying anxiety and depression; can impact sleep), bone health (decrease bone density and increasing risk of fractures), impact on wound healing, increased risk if long term on the GI tract (i.e. perforation), increased blood sugar (hyperglycemia), high blood pressure.”

What’s the deal with birth control and IBD?

Each pediatric gastroenterologist featured in this piece says they have heard from both patients and parents about oral contraceptives aggravating IBD. Dr. Ali says oral contraceptives are consistently linked to an increased risk of IBD.

Dr. Michel says since menstruating is a normal part of development for female patients, active inflammation, low weight, and malnutrition, can all play a role in delaying the onset of it. If a patient is flaring, they might have irregular periods or stop getting their period for some time. Once the problem is addressed—inflammation controlled, normal weight achieved, and malnutrition treated, menses typically resumes. IBD symptoms can also be exacerbated during menses for some women.

When it comes to choosing to go on birth control, and what birth control to choose, Dr. Michel advises patients and parents to be clear about their goals and weigh the risks and benefits.

“Goals for starting birth control can include regulating heavy periods or bad cramps, preventing pregnancy, improving premenstrual symptoms (mood, headache, fatigue), or even managing acne. There are some data about birth control pills increasing the risk of developing IBD, but research is conflicting about whether they increase the risk of flare. I would encourage any patient who is interested in starting birth control to talk with her gastroenterologist about what options might be best for her. An adolescent medicine doctor or gynecologist can also be extremely helpful to have these conversations, weigh pros and cons, and help young women and their families make informed decisions.”

Dr. Kim is no stranger to hearing concerns about the impact of oral contraceptives. She says it’s tough to determine whether birth control specifically aggravates disease.

“Women who have increased diarrhea and cramping around their cycles may have improvement in these symptoms when on birth control. Currently, there is not enough data to suggest birth control directly leads to aggravation of underlying IBD. However, there are other issues to consider when a young woman chooses the type of birth control. There is increased risk of venous thromboembolism (increased risk of forming blood clots) in individuals with IBD. There also is an increased risk for clots associated with combination oral contraceptives whether a young woman has IBD or not. Therefore, a woman who has IBD and goes on oral contraceptives not only has a higher risk of forming significant blood clots, but with more significant consequences from this.”

Dr. Kim’s recommendation? Avoid oral contraceptives with an estrogen component, if possible. Depo-Provera is an alternative, but you need to be aware that it can impact bone density. She says IUDs are safe and highly effective

How best to support young patients

  • Support groups: Discuss concerns regarding how a patient is coping with the IBD team. A social worker or psychologist on the IBD team can be a great resource.
  • Psychosocial assessments
  • Care coordination
  • Supportive counseling
  • Connection to resources

“As a pediatric gastroenterologist, my contribution is to manage their therapy as best I can to achieve remission. After that, we rely on our multidisciplinary team to address the psychosocial aspect of the disease and how this affects them at this stage in life,” said Dr. Moses. “Finally, we encourage the families to get involved with the Crohn’s and Colitis Foundation and attend Camp Oasis, if possible, to meet other children their age who also have IBD. This builds up their social support network in a way that can be life changing for them.”

Dr. Michel says,I try to normalize their feelings, and reassure them that with effective treatment and achieving remission, we are working toward them reaching their full potential. I also think it’s a great time to involve experts like psychologists and child life specialists to help work through these concerns. Parents will often also ask about future fertility (kids and teens usually aren’t thinking of this yet)! It’s always a huge relief for families to learn that we expect normal fertility for our young folks with IBD and that the best way to ensure this is to get good control of disease.”

She advises parents to acknowledge how challenging it can be to go through puberty with IBD.

“Any feelings they’re feeling – frustration, anger, sadness – are ok. Then, I would encourage parents and patients to share these emotional and physical struggles with their healthcare team. Many centers have fantastic psychologists, social workers, and child life specialists that can help young people understand their disease, explore their emotions, and develop healthy coping skills that will serve them now and into adulthood. There are also fantastic resources online through ImproveCareNow and the Crohn’s and Colitis Foundation,” said Dr. Michel.

Dr. Kim advises parents and patients not to be afraid to ask pediatric gastroenterologists and their healthcare team for help.

“I really believe it takes a collective effort to support our children and teens. We are living in an unprecedented time with the COVID 19 pandemic (which has led to social isolation and new stressors with school, peers, and family dynamics),” she said. “Seeking our behavioral health resources (psychology, psychiatry, counseling, social work) is NEVER a sign of weakness – quite the opposite. One thing I would love to see: elimination of any perceived stigma when addressing issues around mental health. It is so crucial to address stress, anxiety, and depression. Besides the obvious impact on quality of life, we know that anxiety and depression can negatively impact an individual’s IBD itself. For the parents out there, I tell them they must check their own guilt at the door. The parents did NOT do anything to cause their child to develop IBD. I always say that you can be mad at the disease but never at themselves.”

Connect with these physicians on Twitter:

Dr. Sabina Ali: @sabpeds

Dr. Hilary Michel: @hilarymichel

Dr. Jonathan Moses: @JonathanMoses77

Dr. Sandra Kim: @SCKimCHP

Let this piece serve as a conversation starter as you discuss your child’s health with their care team. Ask the questions. Get empowered by learning and educating yourself more. As chronic illness patients and parents, it’s a constant learning curve—with each setback and triumph we gain newfound understanding and perspective. Stay tuned for an upcoming article on Lights, Camera, Crohn’s with guidance regarding making the transition from pediatrics to adult doctors.

Helpful Resources

Learn about the Crohn’s and Colitis Foundation’s Camp Oasis

Continued Statural Growth in Older Adolescents and Young Adults with Crohn’s Disease and Ulcerative Colitis Beyond the Time of Expected Growth Plate Closure

Oral Contraceptive Use and Risk of Ulcerative Colitis Progression: A Nationwide Study

Growth, puberty, and bone health in children and adolescents with inflammatory bowel disease | BMC Pediatrics | Full Text (biomedcentral.com)

How IBD Affects Growth in Kids and Teens (verywellhealth.com)

Pediatric Crohn Disease: Practice Essentials, Background, Pathophysiology (medscape.com)

Contraception, Venous Thromboembolism, and Inflammatory Bowel Disease: What Clinicians (and Patients) Should Know

Growth Delay in Inflammatory Bowel Diseases: Significance, Causes, and Management

Circle of Care: A Guidebook for Caregivers of Children and Adolescents Managing Crohn’s Disease

Navigating new mask guidelines: What the IBD community needs to know

With mask mandates ending for most states across the country and the CDC once again changing its guidance about masking, it’s a cause for concern for many who are immunocompromised or considered higher risk for Covid-19. As an immunocompromised mom of three kids under age 5, I feel a bit uneasy about the shift in measures, even though I had Covid-19 in January. I contacted my GI this week to ask her opinion on the mask mandates lifting and navigating this time as an IBD mom. She didn’t hesitate for a second and told me to keep masking—not only for myself but because of my kids. She herself hasn’t stopped masking in public and doesn’t plan to anytime soon.

I polled my followers on Twitter and Instagram by asking: “Do you still wear a mask in public, indoor spaces?” Nearly 500 people responded. On Instagram, 69% responded “yes” to still wearing masks and 31% responded “no”. On Twitter, 88% responded “yes” and 12% responded “no”.

This led me to dig a bit deeper and hear what several top gastroenterologists who specialize in inflammatory bowel disease had to say on this controversial and politicized issue.

Dr. Aline Charabaty, MD, Assistant Clinical Director of the GI Division at Johns Hopkins School of Medicine, and the Director of the Inflammatory Bowel Diseases Center at Johns Hopkins-Sibley Memorial Hospital, offered several fantastic analogies for the IBD community. The one that really hit home to me was talking about family planning and remission in Crohn’s and ulcerative colitis. If you are flaring and want to start a family, the rule of thumb is to be off steroids for at least six months to ensure disease activity is calm. We JUST got through the rampant spike in omicron cases last month. In her opinion, going maskless this soon after that highly contagious variant is premature. She believes we need to wait longer to make sure we are out of the woods and that conditions need to be more stable for a longer period of time. Until then, she recommends those who are more susceptible in the IBD community continue to mask as an extra safety net.

“We are not out of the pandemic. Sure, there are less deaths and fewer severe cases, but people are still getting sick. We saw this happen when we let our guard down and delta hit…then omicron. When you are driving, you wear a seatbelt, follow the speed limit, try not to tailgate, and follow the rules of the road. These are all precautions to drive safely to your destination and avoid an accident. You don’t just do one thing to prevent a car accident. With Covid, we got the vaccines, we’re wearing masks, we’re limiting exposure to large crowds, and measuring risk versus benefit for each of our decisions. It’s not a pick and choose situation of how to keep ourselves and others out of harm’s way.”

Dr. Charabaty went on to say why get sick with something when we really don’t know the long-term effects. We already see Covid can cause a higher risk of depression, heart disease, and autoimmune issues.

“Wearing a mask is such a simple measure. If it adds a benefit, I don’t see why people are saying no to this. This virus can really change your body. Why not add another layer of protection to prevent illness? There are no downsides to wearing a mask, so why not wear it? When you are out and about there are people with weakened immune systems, cancer patients, organ transplant recipients, people on multiple IBD medications…why put these people at risk of infection? The more Covid is transmitted, the higher the risk of mutation, which will cause yet another spike. Each variant has been a result of people letting their guard down to soon with their decision making.”

Dr. Neilanjan Nandi, MD, FACP, Associate Professor of Clinical Medicine, Gastroenterology, Penn Medicine, agrees that while case numbers going down is reassuring, that we are not out of the woods yet. To him, a mask is a sign of empathy for others.

“It’s not about us…whether it’s a caregiver or a family member or friend, this shouldn’t be looked at as an encroachment on our freedom, but rather about showing respect for those around us. The best thing we can do is mask up. Wearing a mask in public, indoor spaces is a smart move because you don’t know the immunization status or exposures of people you don’t know. If you are planning to see family or friends and know people’s vaccination status or if they’ve recently had Covid, you might feel more comfortable not wearing a mask.”

Pre-pandemic photo-May 2019 with Dr. Nandi at Digestive Disease Week in San Diego.

Dr. Nandi reiterated the fact that we’ve learned over the course of the last two years that most of our IBD medications don’t cause an increased risk and may even be protective. While this is reassuring, if you are on 20 mg of prednisone or higher, he highly recommends you mask up as you are more susceptible to illness.

Dr. Uma Mahadevan, MD, Professor of Medicine, and Director of the UCSF Colitis and Crohn’s Disease Center, says every region of the country is different and that your location should be taken into account.

“In the Bay Area we have a high vaccination rate and a low hospitalization rate. You also have to consider the patient’s personal risk and risk aversion.”

Here’s what Dr. Mahadevan tells her patients.

  1. Follow local guidelines for masking
  1. If you are vaccinated and boosted and are in a low-risk area with no mask mandate, its ok to not mask, particularly outdoors. Indoors in crowded shopping areas, etc., I would still consider masking. However, again, low risk patient in a low-risk region, it’s ok not to mask.
  2. For high-risk patients on steroids, double biologics, severely active disease, etc. I still recommend masking.

Dr. Miguel Regueiro, MD, Chair, Digestive Disease and Surgery Institute, Chair, Department of Gastroenterology, Hepatology & Nutrition, Cleveland Clinic, is hopeful we’re headed to what we see with influenza. While of course flu can still be serious and deadly, with enough people vaccinated and exposed to Covid, we can have herd immunity.

“We’re all learning as we go and there’s a lot of “grey” with nothing very “black or white.”  For now, I am recommending IBD patients continue to mask. For those who are immunocompromised, wear a mask in indoor spaces, especially crowded spaces such as airports. In outdoor spaces, it is less clear, but masks are probably a good idea when social distancing is not possible.”

Pre-pandemic photo-May 2019 with Dr. Regueiro at Digestive Disease Week in San Diego

Dr. Peter Higgins, MD, Ph.D., M.Sc., Director of the IBD Program at the University of Michigan, says if a person is unvaccinated, masks are a must. He encourages you to talk with your doctor about Evusheld, a monoclonal antibody against Covid-19 for immunocompromised people and those who cannot be vaccinated for medical reasons.

“If the county you live in is below 10 cases per 100,000 people (CDC is saying 200/100,000 for the non-immunosuppressed), then you can consider not wearing a mask. But admittedly, this is an arbitrary number and 200 cases for every 100,000 people seems too high for the immunocompromised population. Especially if you are around kids, the elderly, or those who have not been able to be vaccinated, showing solidarity and wearing a mask is highly recommended.”

He explained that eating indoors with good ventilation is OK, but that is it hard to prove unless you have a CO2 monitor that can show a consistent CO2 ppm (parts per million) < 650. To give you an idea, Las Vegas casinos have good ventilation systems in place to keep restaurants free of smoke and those measure between 400-450 ppm. Dr. Higgins still recommends people do a rapid test within 12 hours of gathering with friends and family. He adds that as we learn more about long Covid and new variants guidance may once again shift.

Dr. Harry J. Thomas, MD,Austin Gastroenterology in Texas, also recommends patient who are immunocompromised (especially those on anti-TNF’s, prednisone, and other immunosuppressants) to mask up.

“I empathize with people who are worried about being judged by others and I recommend that they share — if they feel comfortable — that they (or their family member) have a chronic disease that places them at higher risk. I do feel that abandoning masks right now is premature, especially here in Texas as well as in other parts of the country with lower vaccination rates. I’m not sure if/when there will be another spike, but we still have about 2,000 COVID deaths each day which is really tragic and indicates that the pandemic is far from over.

My personal take

Personally, my husband and I still wear masks in public, indoor spaces. Our children who are in preschool are one of the few who are still wearing masks at their school. While I understand each person has the right to make their own personal decision for themselves and for their families, it’s disheartening and honestly disappointing to see the lack of care for others who are not fortunate to have the luxury of being healthy. I can’t tell you when I’ll feel safe enough to go into a grocery store or the mall without a mask on, it’s going to take time and assurance from my care team that I’m not making a rash decision that could put myself, my family, or even strangers at risk. It’s complicated. I get it.

My daughter at preschool this week. Still masked up.

When you’ve lived with a chronic illness like Crohn’s disease for nearly 17 years and been on immunosuppressive drugs ever since, your perspective shifts. You quickly realize you are not invincible. You recognize and empathize with those who have health struggles and depend on the greater good to make sound decisions. It’s a small act of kindness for the sake of health and safety. Talk with your care team about navigating this new normal. Don’t base your judgements on social media, the news, or your political beliefs. This is an ever-evolving discussion. It’s been a long two years. We’re all tired. But that doesn’t mean apathy is the answer. You may not care, but you are making a statement to those who are vulnerable when you go maskless indoors.

It’s ok to be unsure. It’s normal not to want to be judged or feel your kids will be outcasts if they’re the only ones at school masking. It’s understandable to feel a bit lost about what is best. But if a mask makes you feel comfortable, safer, healthier, you do you. Know that the medical community and so many others stand in solidarity with you.

What the IBD Community Needs to Know about Getting an Additional Dose of the COVID-19 Vaccine

Over the weekend (Saturday, November 6) I received my third dose of the Pfizer vaccine. When I had my second vaccine on August 11, I never dreamed I would be getting another jab so soon. But here we are. In talking with several IBDologists and patients I felt the need to expound on this topic, as misinformation is driving quite a bit of confusion about what additional doses and boosters mean for the IBD community and how we can best sort through all the information being thrown our way.

What’s the difference between an additional dose (3-part vaccine series) vs. a booster?

Dr. Meenakshi Bewtra, MD, MPH, PhD, Penn Medicine, helped me better understand this by explaining, “a 3rd dose implies that you had a less-than ok response to two doses and need a “3-dose regimen” to get the same response that someone else would get with two doses.”

The 3-dose regimen caters to those who are severely immunocompromised—those on chemotherapy and organ transplant recipients.

“Most IBD patients do NOT have this problem. Some small studies have shown varying responses; the largest is PREVENT-COVID which was over 3,000 patients. The study found that those on monotherapy TNF had similar response to the COVID vaccines as the general population. It was only in the setting of combination therapy (anti-TNF plus azathioprine or methotrexate) that you had a blunted antibody response (again–this was a research study),” said Dr. Bewtra.

She went on to say she has not been recommending that all her patients get a 3rd dose—rather, reserving that for patients who are on combination therapies. At the same time, this is a very fluid discussion, and the decision needs to be made on a case-by-case basis between each patient and their physician.

A booster is if you had an adequate response to the first 2 doses and are now 6 months past your primary series and fall into the recommended categories (over 65 years old or age 50+ with high-risk medical conditions), if you are part of a younger age group with high-risk medical conditions, or for those who work in occupations that put them at high risk for COVID. Booster shots are most effective 6 months after your initial series for Pfizer and Moderna and 2+ months after J&J, although the data really supports waiting until at least 6 months for best response. Age is the biggest determinant of needing a booster, whether you have IBD or not.

Dr. Peter Higgins, MD, PhD, M.Sc., University of Michigan Health, explained this clearly on Twitter. He tweeted, “It is a catch-up dose for folks who for various reasons (anti-TNF’s, steroids, chemo) will not have a great response to two doses. To catch-up to everyone else. Then a booster dose later to keep pace.”

I’m *only* 38 years old. I’m *only* on Humira. Why am I getting a 3rd dose two months after my 2nd vaccine?

I saw my gastroenterologist for a check up last week and she ordered a SARS-Cov-Z Antibody (IgG) Spike Semi Quantitative test at Quest Labs. My results came back and from a range of 0-20, I was at 4.42. My GI was surprised my response had dwindled so quickly and recommended I receive a third dose to help mount a more robust response.

Dr. David Rubin, MD, Professor of Medicine, University of Chicago, and Chair of the National Scientific Advisory Committee of the Crohn’s & Colitis Foundation told me that multiple studies on antibody response in patients with IBD have shown that after two doses the titers are similar to that of the general population. So, my result, is an aberrancy compared to the data. He said getting a 3rd dose seems right for me, given my personal results.

“We have suggested the booster for everyone and think of the COVID vaccines as part of a 3-dose series. When it comes to true protection from the infection, memory B cells (cellular immunity) are more important than antibodies. There is not a commercial test for that yet, but we are studying it.”

In a recent talk Dr. Rubin gave about COVID, vaccines, and the updated recommendations for additional doses and boosters, he discussed how IBD is a condition of an abnormal immune response. Therapies to manage IBD are predominately immune-based and immune-modifying. The information shared by the CDC and FDA is not specific to IBD and is confusing (for everyone).

“CDC recommends individuals should get a third vaccine if:

  1. Previously received two doses of an mRNA vaccine
    1. Currently taking select therapies, including anti-TNF and anti-metabolites
    1. “Other biologic agents that are immunosuppressive or immunomodulatory”
    1. High dose steroids (prednisone ≥20 mg/d or equivalent for ≥2 weeks)

All other individuals are recommended to get a booster 6-8 months after second mRNA vaccination.”

But wait, what’s the recommendation on antibody tests? Are they valid?!

This is where I get confused too, folks. Prior to receiving my antibody test and following my doctor’s orders I was not aware that the FDA and CDC both strongly recommend NOT checking or acting on antibody levels, as the tests outside of research studies are unreliable and unvalidated. Antibody tests do not paint a full picture of our immune system.

“There are strong recommendations from the CDC, FDA and ACIP (Advisory Committee on Immunization Practices) that patients NOT check antibodies nor use them in decision making. The only time they should be used is in the setting of research studies,” said Dr. Bewtra.

The reason for this is multifold:

-Antibody tests are not validated.

-Since they are not validated, there is no comparison for values. For example, my 4.42 on one test may be completely different in a different test.

-We know that antibodies are testing only one aspect of the immune system—there is a LOT more to immunity than an antibody level.

Dr. Jami Kinnucan, MD, University of Michigan Health advises all her IBD patients to receive a third dose, or a booster vaccination based on their risk factors and immunosuppression medications.

Dr. Kinnucan says, “Overall the current recommendations are to get a dose #3 on certain immunosuppressive therapy, which is different than a true booster dose. In addition, it is hard right now to understand what the true threshold of immunity is with antibody testing so I would not put too much into antibody test results. I do not recommend that patient’s routinely have their antibody status checked (unless they are involved in current studies). I would recommend getting dose #3 or booster dose for IBD patients.”

Vaccinated diverse people presenting shoulder

During the holidays we should all continue to follow CDC recommendations when it comes to social gatherings, social distancing, wearing masks, and properly washing our hands. Everyone that you spend time with should be fully vaccinated so the only thing being spread is holiday cheer. If you plan to spend time with anyone who is not from your immediate bubble, it’s recommended they take a rapid test before coming over.

Key Reminders as We Head into the Holidays

Vaccines are not 100% protective and Dr. Bewtra says “no one is fully vaccinated.”

“No one should think that just because they’ve had two vaccines, or 3 or 4, that they are safe. Protection is a function of the community: when community levels are high, even if you just got​ your vaccine, you need to wear a mask and practice all the recommendations from the CDC.”

What are the studies saying about the IBD Community

The data from science is highly variable. Studies looking at Rheumatoid Arthritis are not translatable to IBD, even when patients are on the same drugs. We have the real-world data from IBD, and it shows that the vast majority of IBD patients respond to vaccines appropriately. So not everyone needs to rush out to get a 3rd dose.

“We are doing a lot of vaccinating “the worried well” in this country. That may be fine because we are in a rich enough place to do that over and over, but it should not infer a feeling of false protection​ and it may be unnecessary,” said Dr. Bewtra.

Closing Thoughts

On the fence about receiving a 3rd dose and/or a booster dose? Have a discussion with your physician who specializes in caring for your IBD and prescribes your medications. Much like how IBD and COVID manifest differently in each person, it’s not fair to make blanket decisions about the entire patient population.

Dr. Rubin wants to reassure those with IBD that they are not at increased risk of bad COVID outcomes (but not at decreased risk either). He says most patients with IBD on therapy beyond 5-ASA or budesonide are eligible to get a third dose now. For patients on combination therapy with anti-TNF and thiopurine, methotrexate or high dose steroids, it’s reasonable to get the third dose/booster early.

Stay tuned for the evolving research. As the months go by and more research studies are completed, we’ll have a clearer picture of how to tackle this as well as additional guidance.

Save the Date: Facebook Live Event on Global Perspectives on COVID + IBD

The South Asian IBD Alliance (SAIA) is hosting a Facebook Live event Saturday, November 20 at 10 am EST. Patients and physicians will share their perspectives on COVID from the United States, United Kingdom, and India. Doctors will explain study data on serocoversion (development of specific antibodies in blood serum as a result of infection or immunization) in IBD patients and what their thoughts are on boosters and a 3-dose regimen, along with their viewpoints on mixing and matching vaccines. Patients will share their experiences from each respective country and discuss the challenges the pandemic has caused in terms of care.

Additional Resources

Crohn’s and Colitis Foundation: COVID-19 Vaccine Additional Dose Position Statement 

COVID-19 Vaccines and IBD: What patients need to know (article by Dr. David Rubin)

Third doses of SARS-CoV-2 vaccines in immunocompromised patients with inflammatory bowel disease (The Lancet)

Podcast: IBD Drive Time: Does my Patient Need A COVID-19 Vaccine Booster?

Studies about how IBD patients are responding to COVID-19 vaccines:

If you don’t do so already, be sure to follow these experts on Twitter for up to the moment information:

Dr. Bewtra: @DrsMeena

Dr. Rubin: @IBDMD

Dr. Kinnucan: @ibdgijami

Dr. Higgins: @ibddoctor

The Patient Experience: Biosimilars & What Leading GI’s Want You to Know

Biosimilars. When you hear the word how does it make you feel? Maybe a little skeptical. Maybe a little uncertain. Maybe a little leery. If so, you’re not alone. I’ve been on my current biologic more than 13 years and when I think about having to possibly make a switch in the future it makes me nervous, too. That’s why I called on IBD specialists and gurus Dr. Miguel Regueiro, Professor and Chair of the Digestive Disease and Surgery Institute at the Cleveland Clinic and Dr. Christina Ha, MD, FACG, AGAF, Cedars-Sinai to help educate the patient community and put falsehoods and myths to rest. Biosimilars are here to stay so it’s imperative we get comfortable with the uncomfortable.

What is a biosimilar?

First things first, let’s get the definition out of the way so you know what we’re working with here. Biosimilars are not the generic version of the biologics many of us are accustomed to. A biosimilar is a product, usually a medication, that is formulated in a fashion that is similar to the “reference” product, also known as the “originator” medication. Think Infliximab (Remicade) and Adalimumab (Humira).

I love the way Dr. Ha explained this, “It’s like identical twins sharing the same DNA but having different fingerprints. With biosimilars, dosing, administration, optimization, monitoring, and plan of care is the same, nothing changes except the Infliximab is now Inflixilmab-dyyb, for example.”

How You’re Told You Need to Switch

You may be wondering how this conversation and discussion even starts and how it translates over to the patient experience.

“The physician and patient are contacted by the insurance company indicating that the patient must switch to a biosimilar. This allows for some discussion between the physician and the patient. Although this should be the fashion in which it occurs, I know that this is not always the case and sometimes the notification is last minute or done in a way that leaves little time for education and discussion between the administration of the next dose of biologic and notification by the insurance,” said Dr. Regueiro.

Cost Savings and Access to Patients

I want to preface this by saying the cost savings varies from patient to patient and is largely dependent on a patient’s insurance company or health plan that covers the payment of their medication.

Dr. Regueiro says, “To provide a simple overview, each insurance company/health plan will contract with a pharmaceutical company for a certain medication. Much of this is dependent on getting the best price for the insurance company. A biosimilar is typically cheaper than the original (originator/reference) medication and the insurance company will then list the biosimilar as its preferred biologic for that condition, e.g., Inflectra or Renflexis for Crohn’s disease or ulcerative colitis. This makes the approval of that biosimilar “easier” for the patient and therefore access better. The question of where the savings are realized is another matter. Even cheaper drugs do not translate to savings directly to the patient.”

If you’ve been on a biologic “originator” successfully and are told you suddenly must make the switch, it’s not uncommon. Dr. Regueiro says he has many patients who have found themselves in this position. His advice? Speak to your healthcare team, but also go to trusted resources for education, e.g., the Crohn’s and Colitis Foundation website has some useful information for patients about biosimilars.

Addressing patient hesitancy

It’s no surprise this can be an emotional discussion. I try and envision myself being told that I had to switch after more than 13 years, and I know I would be crying because of the comfort and confidence I have had with my current therapy.

“The idea of switching to a biosimilar is fraught with concern. I typically acknowledge their concern, but then explain the data. There have been many studies that have shown that switching from a biologic to a biosimilar is well tolerated, is equally efficacious, and does not incur any different safety risk. I tell the patient that we technically cannot say that the biosimilar is the “same” as the biologic, but in essence it is. I also explain that I have had hundreds of my own patients switch and I have not seen a problem. In fact, in some patients I may get a drug level of the biologic before switching and then the same drug level of the biosimilar after switching and see no difference,” explained Dr. Regueiro.

For example, there is a blood assay for Remicade (Infliximab) that measures the Infliximab level and antibodies to Infliximab. When Dr. Regueiro has had patients switch from Remicade to a biosimilar, e.g., Renflexis or Inflectra, and then measure the same exact drug assay, the results of the Infliximab level and antibodies to Infliximab are the same. The biosimilar works in an identical fashion to the original biologic, and the blood assays show the same results. The body “cannot tell” the original biologic from the biosimilar.

Let’s read that sentence again. The body “cannot tell” the original biologic from the biosimilar.

Dr. Hasays, “The key here is to understand that you are being switched to an equivalent not inferior agent. Biosimilars are rigorously studied for safety, effectiveness, antibody formation with a lengthier, more involved FDA approval process than generics.”

Why Biosimilars are NOT generics

A generic medication has the same active ingredient as the brand name medication. An example would be the generic medication mesalamine for the brand name medication Asacol. Asacol’s “active ingredient” is mesalamine and the generic is simply formulated as mesalamine. The “packaging” of Asacol makes it Asacol, but its active ingredient is mesalamine and is identical to the generic formulation of mesalamine.

Dr. Ha explains why biosimilars are not generics.

“Generics are chemical compounds where exact replicas of the active ingredient are possible. However, biosimilars are biologic agents, complex protein structures constructed from living cells. Exact replicas aren’t possible but nearly identical structures can be manufactured – remember, these are very sensitive compounds. That’s why these medications need to be refrigerated and handled differently than a generic.”

I asked Dr. Reguiero if there’s ever a situation where he advises against a patient being switched to a biosimilar. He said generally, no.

“The only main question will be if a patient has already been on a biosimilar after the originator biologic and then needs to switch to another biosimilar. This would be a “multiple switch” rather than a single switch from the original biologic to biosimilar. Based on the limited data to date, and similarity between all of the biosimilars and original biologic, I do not even see this as a problem, but we need more research to make a final conclusion onto multiple switches.”

“Delaying treatment to stay on a version of a medication that really is not meaningfully different than the biosimilar may lead to far worse consequences than staying on schedule by switching to a biosimilar. Remember, delaying anti-TNF schedules may increase risks of antibody formation, infusion/injection reactions, and flares. I am far more concerned about staying on schedule and not missing doses than I am the biosimilar vs reference,” said Dr. Ha.

What if a biosimilar fails?

If a biosimilar fails, Dr. Regueiro looks at it the exact same way as if an original biologic fails. For example, let’s take the case of biosimilar Inflectra for Remicade.

“If a patient is started on Inflectra as their first biologic ever and it stops working, I generally check blood levels to determine if the patient has developed antibodies to Inflectra and that this is the reason for failure. If they have developed antibodies, and the Inflectra has worked well for a long time, then I would switch to another anti-TNF, but not another biosimilar to Remicade. The reason for this is that if a patient develops antibodies to the biosimilar, they will form antibodies to the original biologic or another biosimilar of that same biologic. However, I would switch this patient from Inflectra to Adalimumab (Humira) or one of the other anti-TNFs if needed. I would do the exact same thing if the first biologic I used was Remicade and it failed due to antibody formation.”

I went on to ask Dr. Regueiro when he would switch a patient to a biologic medication from a “different class.”

“Let’s take the example of Inflectra or Remicade. If a patient is started on Infectra or Remicade and they have no response from the beginning, and their drug levels of Inflectra or Remicade are good (and they have not had antibodies again) this means it should be working and it is not – this is a primary failure of that medication. In that case, not only would I not switch to another biosimilar or back to the original biologic, but I would also completely switch away from the class of anti-TNF, e.g., Humira, Cimzia, Simponi, as the patient is likely a non-responder to all anti-TNFs. In this case, I’d move onto something like Entyvio, Stelara, Xeljanz, or Zeposia (depending on whether it’s ulcerative colitis or Crohn’s disease).”

What’s coming down the pipeline for patients?

With all the biosimilars on the market and many more on the way—Dr. Regueiro and Dr. Ha say it’s quite likely all patients can expect to be switched off their current biologic at some point as insurance companies are able to get the biosimilar as a cheaper cost.

As far as savings programs, many of us are accustomed to with our biologics (I pay $5 a month for two injections), this would be dependent on what the company that makes the biosimilars offers and may look quite different to the originator biologic’s savings programs.  However, I would anticipate the patient would not pay more for the biosimilar.  There would either be a cost savings program with the pharmaceutical company that makes the biosimilar, or, more likely, the insurance company would keep the out of pocket cost the same for the patient.

Biosimilars are administered in an identical fashion to the originator biologic. So, you won’t be forced to go from doing a self-injection to getting an infusion. I asked Dr. Reguiero about Humira’s biosimilar in the future, and he anticipates that it will be citrate-free, just as the originator is now in the States.

Pediatrics and Biosimilars

As biosimilars come to market, the indications should be the same for the originator biologic. That is, if there is an approved indication in pediatrics for the originator biologic, the same should be true for the biosimilar. However, the FDA will make final guidance on the indications for a biosimilar and they could vary slightly on which diseases are approved and which age of patient approved.

What Patients Have to Say

Christina received a letter from her insurance company in June letting her know that Remicade was no longer approved and that she would be switching over to Inflectra in July. The insurance company reached out to her directly and had not informed her GI. She was five months pregnant and was stressed and anxious about switching medications in the middle of pregnancy.

“I have been on Remicade since September 2013 and it’s working really well for me. My GI was super supportive with my desire to stay on Remicade through pregnancy and agreed that I should not switch medications. In part of the letter for my insurance company there was an appeal process, which my GI did on my behalf. A few weeks later I got a letter in the mail from my insurance company that my appeal was denied. I contacted my G.I.’s office and she had someone in her office do a follow up appeal. The insurance company finally agreed to approve me for Remicade through my due date, October 23rd.”

Christina’s baby was born October 11th, so she’ll be making the switch this week while she’s postpartum.

Vern lives in Canada and the government there forced him to make the switch.

“The cost is partially covered by the government. I was pissed to say the least. They kept telling me it was safe, but I wanted to see evidence it was safe to switch to a biosimilar after someone had been on a biologic long term. I never got an answer. Luckily, I’m doing fine, and I have not noticed a difference.”

Lizzy highlights the emotional struggle biosimilars burden patients with.

“Even though I don’t see an uptick in symptoms and my remissions has been maintained, emotionally the switch was really difficult. My insurance forced me to switch. I was extremely sick for a long time before starting Remicade while I was hospitalized. So, I was really afraid of the switch making me sick and of course it was horrible not to have a choice in my healthcare.”

Kelly attests to the emotional struggle and disappointment. She says she spoke extensively with her GI prior to making the switch and did her on own research.

“When I received the letter from my health insurance company telling me I would be forced to switch to a biosimilar I was disappointed. I had been on Remicade for more than two years and it had only recently put me into remission. But I knew the switch was coming, having heard from many people in the IBD community that they were being forced as well. I had already done research on the data from Europe and Canada showing that biosimilars of Infliximab had the same efficacy and safety profiles as Infliximab.

She’s now had two Inflectra infusions and hasn’t noticed any difference in the way her body handles the medication. Kelly is crossing her fingers for a continued great experience and hopefully no more frustrating insurance shenanigans.

Madelynn was on Remicade prior to being switched to Inflectra. Unfortunately, her care team and her insurance failed to communicate the change to her. She shockingly discovered the switch was made after proactively reading medicine notes on the patient portal.

“I was nervous about it, and a bit upset. Who wouldn’t be after being in remission with a medicine then having it randomly changed? I ended up researching quite a bit about it, which helped calm my nerves. I also asked more questions of my medical team. I was worried about the biosimilar not working and causing a flare and of possible side effects. Keep in mind, I have Remicade induced side effects already. Could Inflectra make them worse? When a medicine keeps you in remission, that is something you want to hold onto for as long as you can. If you are taking any medicine, never be afraid to ask questions, research, and advocate for yourself. If something does not work, speak up!”

Madelynn has only received one infusion of Inflectra, but so far, she feels well and notices no changes with her IBD.

A Word from the Crohn’s and Colitis Foundation

Laura Wingate, Executive Vice President of Education, Support, & Advocacy for the Crohn’s & Colitis Foundation encourages patients to learn as much as thy can about not just biosimilars but all treatment options available so we can be active and informed partners in making decisions with our healthcare teams.

 “If you are informed you need to switch from a biologic to a biosimilar, you might be worried and that’s normal. But remember that biosimilars are just as safe and effective as your original therapy. Don’t be afraid to ask questions of your healthcare providers about the switch and why it’s happening and share any concerns you have with them. You can also contact the Crohn’s & Colitis Foundation for additional information, education on biosimilars, and support.”

Helpful Resources on Biosimilars

If you have questions about biosimilars– talk to your health care team. The more education, resources, and support they can provide you with to bolster your confidence that the biosimilars are an important part of IBD treatment, the better. I know personally as someone who depends on a biologic to maintain my remission, that doing the research for this article has made me feel a lot more confident and comfortable about biosimilars and what they mean for the patient community.

There are a several great resources about biosimilars to check out:

Crohn’s and Colitis Foundation: Biosimilars What You Should Know

Crohn’s and Colitis Foundation Biosimilar Webinar from September 2021: MyIBD Learning: Understanding biosimilars: What IBD patients and caregivers need to know

American Gastroenterological Association

FDA

Inaugural Autoimmune Summit just what the patient ordered

This post is sponsored by the Autoimmune Association. All thoughts and opinions shared are my own.

An educated patient is an empowered patient. Over the weekend the Autoimmune Association presented its Inaugural Autoimmune Summit that aimed to do just that. The virtual two-day event featured 23 educational sessions and more than 50 autoimmune experts including physicians, nurses, policy experts, and of course, patient advocates.

The Summit covered a wide variety of important topics that impact patients and caregivers who live with autoimmune conditions. I had the opportunity to moderate a panel discussion about fertility, family planning, and pregnancy alongside Dr. Marla Dubinsky, Chief of Pediatric Gastroenterology at Mount Sinai and Co-Director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center and Mariah Leach, a mom of three who lives with Rheumatoid Arthritis and Founder of Mamas Facing Forward. As an IBD mom of three chidren myself, I’m extremely passionate about sharing guidance and support for fellow women on this subject.

During the discussion, Dr. Dubinsky touched on many aspects of the journey to motherhood and beyond with IBD, but one comment she made resonated with me. She said the greatest gift a woman can give their child, is to stay on their medication, and allow their baby to thrive in an uninflamed environment. As someone who needed and depended on my biologic with all three of my pregnancies that comforted me greatly and really struck a chord.

Other topics of discussion during the Summit included tips and tricks for managing multiple specialists to clinical trials, health equity, advocating on Capitol Hill, and complementary medicine.

A dream come true

Lilly Stairs, Vice Chair of the Board of the Autoimmune Association and Summit Lead, lives with Crohn’s disease and arthritis. As a patient advocate, she understands the vital importance of providing those who live with chronic health conditions to share their voice and articulate their needs and struggles.

“It has been a dream of mine and the Autoimmune Association’s to plan an event that unites community members from across autoimmune conditions. Our patient odysseys share deeply rooted similarities. By coming together, we can accelerate autoimmune education, awareness, advocacy, treatment, and someday, cures.”

Goals of the Summit

The goals for the Summit were three-fold. Organizers and presenters like myself hope you walked away feeling connected to people across the patient community, while learning tangible tips for managing your autoimmune conditions. Lastly, the hope is that attendees and Summit participants feel energized and excited about what the bright future holds for those living with autoimmune diseases.

Lilly went on to say, “Events like the Autoimmune Summit are essential engagements for patients and caregivers to participate in. These events provide tools to navigate life with chronic illness and empower patients with the knowledge they need to be “CEO, secretary, and treasurer of your care” as Hetlena Johnson, Lupus Patient Advocate so eloquently stated in the Managing Multiple Autoimmune Conditions panel.”

Events like this are a reminder that we are not alone in our journeys. Even though chronic illness can be extremely isolating, events like the Autoimmune Summit offer the opportunity for connection that often feels like much needed chicken soup for the soul. The camaraderie that is possible even though Zoom has a lasting impact on helping to lift the burden and self-doubt many patients face.

From the Speakers

Tina Aswani Omprakesh participated in a panel on complementary medicine and autoimmunity. As an ostomate who juggles Crohn’s disease, Gastroparesis, and IBS, she knows firsthand how imperative it is to take on illness with multiple approaches.

“This is an important subject that’s often not discussed in the autoimmune space. The reality is that many patients are thinking about exploring it but don’t know how to navigate it in a way that can help complement their existing therapies. These conversations are essential to proliferate both credible information and sources of complementary therapies so patients can truly live their best lives possible.”

Molly Schreiber lives with Type 1 Diabetes, Rheumatoid Arthritis, and POTS. During the Summit, she spoke about what it’s like to manage multiple autoimmune conditions.

“Anytime I can share my story, my hope is that attendees feel less alone in their battle with chronic illness. We may have different health conditions, but our fight is often the same—pain management, medical providers who listen, and affordable medications we can easily obtain.”

Alisha Bridges is a patient advocate who lives with Psoriasis. She participated in a breakout session geared towards dermatology. She says having the chance to speak at the Autoimmune Summit was an honor.

“I hope my story helped viewers to better understand the unique challenges of living with psoriasis as a woman of color especially in the clinical trials sphere. These conversations are imperative to elicit change for better care of patients of all backgrounds.”

Curtain Call

It’s our hope attendees discovered tips for managing autoimmune disease from patient advocates like myself who understand your reality, while also learning about the latest research and future treatments on the horizon.

Did you miss tuning into the first-ever Autoimmune Summit? No worries! All the presentations were recorded and will be shared in the weeks ahead. I’ll be sure to share the Fertility, Family Planning, and Pregnancy discussion I was a part of on my social media channels as soon as the video becomes available.

Thank you to all who tuned in, to all who participated, to the organizers, like Lilly, and the generous sponsors who made this happen. It’s amazing to see what’s possible when patients have a proverbial seat at the table alongside medical professionals and digital health companies. Our voices matter and time and time again we’re being heard loud and clear.

Follow the Autoimmune Association on social media

Instagram: @autoimmune_diseases

Twitter: @AutoimmuneAssoc

Facebook: Autoimmune Association

IBD Motherhood Unplugged: Scopes, Scans, and Breastfeeding

The date for my next scheduled colonoscopy is on my calendar. Even though my scope is one month away, I’ve already started the mental prep of what’s to come. When you’ve had too many colonoscopies to count you know what to expect…which is both a blessing and a curse. This time around I’m exclusively breastfeeding my 3-month-old son. So, like any IBD mom may wonder, how does that correlate when you’re taking prep that cleans out your system and are put out for the procedure?

I checked in with Dr. Aline Charabaty, Assistant Clinical Director of the Division of Gastroenterology at Johns Hopkins School of Medicine, and Clinical Director of the Inflammatory Bowel Disease Center at Johns Hopkins-Sibley Memorial Hospital, as well as my own gastroenterologist (GI) so I knew what to expect and so I could pass along the information to you.

Juggling Kids and Prep

I’m already anticipating the hustle and bustle that I’ll be dealing with as I guzzle down the disgusting concoctions with my 4-year-old and 2-year-old running around as I care for our newest addition. Luckily, my mom flies in for every single colonoscopy (even before I had kids!) to offer emotional and physical support. Now, she gives me a hand with my kids, and this allows my husband, Bobby, to take me to the procedure and celebrate with me after it’s over. Highly recommend you line up childcare when prepping for a colonoscopy so you can focus on yourself and not deal with the stress of mom life on top of it.

Snuggling with my son, Reid, while I did my prep in 2019.

Dr. Charabaty understands what a challenge this can be and has fantastic advice for IBD moms on prep and procedure days:

  • Tell yourself you are doing the right thing taking care of your health, to stay well for you and for your kids.
  • Explain to the kids why mommy is a bit tired today, why she is not sharing their food and why she is going to the bathroom a lot.
  • Enlist help!! Have someone you trust, and who the kids know well, to keep them company and look after them while you are prepping the day before and on the day of the procedure. You need a responsible adult who is fully awake and alert to be with the kids and keep them safe during these days.
  • If your child is old enough to understand, have them play an active and fun role in this prep, for example reminding you to drink fluid during the day from a special cup they chose for you.
  • Hug your children often in between trips to the bathroom, to keep you going.
  • Give yourself plenty of rest after the procedure so you can be fully present to your children the next day.
  • Skip co-sleeping the first night after the procedure, as you might not wake up as usual in the night.

In the days leading up to my scope, I put myself on a self-imposed liquid diet 3-4 days ahead of time to ease the prep. It’s hard enough when I’m not trying to nourish a little person, along with myself. Anyone who has breastfed a child knows how hungry it can make you. My GI told me that despite only having liquids I would not need to supplement with formula. At the same time, she suggested I drink Ensure Clear Protein, which will not affect the prep and will help it. To combat dehydration, she reminded me to drink plenty of water up until two hours before the procedure.

“Breastfeeding women lose an average of 25 ounces of fluid a day through their milk. During the colonoscopy prep, make sure you drink plenty of fluid to keep the prep going and the milk flowing! Consider breastfeeding or pumping just before leaving for the procedure and as soon as you are recover and are awake after the procedure, to minimize discomfort of full breasts and minimize disruption in the usual breastfeeding/pumping schedule and optimize the volume of milk recovered,” explained Dr. Charabaty.

If nursing gets to be too much while I’m in the thick of my prep, I plan to tap into my freezer supply of milk so that my mom or husband can feed the baby while I’m holed up in the bathroom. By being proactive and thinking of these moments ahead of time, it’s one less thing to worry about and stress over.

Is Pump and Dumping Necessary?

Since we all know what colonoscopy prep makes us do, my initial thought was that I would need to pump and dump so my son wasn’t pooping up a storm along with me. I envisioned myself on the toilet with my pump nearby…talk about a living hell! Luckily, my GI said there’s no need to pump and dump with the prep or with the procedure since my care team uses Propofol and Dr. Charabaty agrees.

“Preps like Miralax, Golytely, Moviprep, Fleet phosphosoda, and Dulcolax, are not absorbed from the gut and do not enter the breastmilk; so, no need to pump and dump with preps, save every drop of this precious liquid! There are older recommendations to pump and dump the milk 4 hours after receiving anesthesia; however, review of the data show that most drugs used for anesthesia (midazolam, fentanyl, propofol, ketamine) do not cross into the breastmilk or if they do, the concentration for the drug in the breast milk is too low to affect the baby.”

Click here to lead the latest recommendations from the Association of Anesthetists that supports this guidance.

What about prep for MRE’s and CT scans?

“Radiological contrast agents used in CT and MRI are safe during breastfeeding, but be cautious with Technetium containing contrast that is used for nuclear medicine procedures. Some recommend pumping and dumping for 12 hours; other recommend pumping for 72 hours. Store the milk and only give it to the baby after it has been stored for 72 hours.”

The bottom line

“You can continue to breastfeed baby as usual following the colonoscopy (or endoscopy), as soon as you have recovered from anesthesia, and you are awake enough to hold the baby! Talk to the anesthesiologist before and after the procedure for advice, in case different or unusual medications were needed during the procedure. If you feel tired or sleepy, let someone else handle the feeding. Kudos for taking care of both your GI health and baby’s health!”

As an IBD mom having this intel is extremely comforting and puts my mind and heart at ease as I prepare for another colonoscopy, this time with another little one in tow.

IBD Motherhood Unplugged: My Personal PIANO Study Results

As an IBD mom of three who stayed on my Humira (adalimumab) injections until late into my third trimester with all my pregnancies, I recognized the importance of contributing to ongoing research about the safety and efficacy of biologics. When I was approached to participate in the PIANO (Pregnancy Inflammatory bowel disease And Neonatal Outcomes) study for my pregnancy this past year I jumped at the opportunity. While I knew staying on my medication until 37 weeks pregnant would pass Humira through to my baby and that it is considered to be safe, I didn’t know much beyond that.

My son Connor is 8 weeks today. The day of my C-section blood samples were taken from him, me, and my umbilical cord. The purpose of the samples was to measure the concentration of the Humira at the time of delivery. The process in the hospital was simple. Detailed instructions were mailed to me at home ahead of time. When I walked into the hospital for my scheduled C-section my husband and I handed over a small box that included three vials, an ice pack, and proper packaging for the transfer from St. Louis to California to the nurse who was prepping me for surgery. Once all the samples were ready to go my husband made a quick stop at FedEx to hand over the package and voila the science of it all was on its way.

The Results

The past few weeks we’ve anxiously awaited the results. This week, we received them. I have an almost 4.5-year-old son, a 2.5-year-old daughter, and a newborn. With each pregnancy—Crohn’s-wise, the experience was flawless. I felt like a “normal” person. Foods that typically trigger me, didn’t cause any issues. If I wanted a cup of coffee, I didn’t pay the price. It felt glorious to have zero abdominal pain for all those months and know that my babies were thriving in utero. I credit my own health and deep remission and my children’s health to the fact that I chose to follow my care team’s recommendations and stay on Humira until the final weeks of my pregnancies.

When the results popped up in my email inbox, I was nursing Connor. I felt a few emotions, more than I had anticipated. I hesitated to open it. Even though I could see Reid and Sophia watching TV and know how healthy they are, it still made me feel a rush of mom guilt to know that I needed a heavy-duty medication to bring all three of my children into this world and that even though studies like PIANO have shown the safety profile, that as IBD moms we still worry and wish we didn’t need to do injections or get infusions while a life is growing inside of us.

I texted my husband Bobby while he was at work and expressed how I was feeling. His response, “It’s all good babe, I’m sure it’s emotional but kids are all healthy and in good shape so just thankful for that. You did good.” Having a supportive partner through your patient journey and especially through parenthood makes all the difference.

Here are my PIANO study findings. I stopped medication at 37 weeks, and my last injection was 16 days prior to C-Section and this blood test.

My blood—7.3 mcg/mL

Connor’s blood—6.8 mcg/mL

Cord blood—5.9 mcg/mL

When I saw the numbers, my eyes filled with tears. Even though just looking at the numbers didn’t mean a whole lot, it just showed me that my baby had medication in his system, and it made me feel sad. I knew this would be the case—but I want to be transparent that it did upset me, even though I know it was for the best and have seen how my other children have thrived despite their exposure.

I waited to share this so the PIANO study’s lead organizer, Dr. Uma Mahadevan could weigh in and provide further explanation for not only myself, but for our community. She told me that in the PIANO study,  the concentration of Humira for baby on average is 9.4 mcg/ml (range 2.5-26) and for moms 25 mcg/ml (range 0-56.4). As stated above, I was at 7.3 mcg/ml and Connor was 6.8 mcg/ml.

“Cord blood is the blood from the baby that is left in the umbilical cord and placenta after birth. It comes from the baby, so those concentrations are similar. Beginning around week 14 of pregnancy the placenta has a receptor called FcRn. This grabs antibody by the “Fc” portion and pulls it actively from mom to baby. This is most efficient in the third trimester when 80% of antibody transfer occurs. Since Humira is an antibody, it gets pulled across the placenta as well.”

Dr. Mahadevan went on to say that baby often has more drug at birth than the mom, but that was not the case for me. The PIANO study has shown several positive outcomes for IBD moms:

  • There is not an association between the amount of drug present in a baby at birth with infections.
  • Even though there was no increased risk of infection seen based on exposure to anti-TNF or on drug level at birth, in theory these babies (like Connor) are considered immunocompromised until no drug is present. For Humira that’s about 3 months, for Remicade (infliximab) that’s about six months.

“My advice to moms is that all the risks to the baby seem to come from disease flare rather than from medication. In a large French study, the risk of infection in baby was in moms who flared in the third trimester, not based on anti-TNF exposure. Risk of pre-term birth is increased with disease activity, not with anti-TNF medication. Risk of miscarriage comes with disease activity, not anti-TNF use. There is a clear and significant risk from having a flare during pregnancy. Compared to babies of IBD moms not exposed to medications, there is no evidence of increased harm to the baby (at least out to 4 years of age) from TNF exposure,” explained Dr. Mahadevan.

Hearing this was music to my ears and was extremely comforting. Point being—there’s a much greater likelihood of pregnancy complications if your IBD is not managed and if you flare than if you stay on your medication and keep your IBD controlled.

“We have completed our breastfeeding study which showed very minimal transfer (a fraction of what transfers by placental blood) and no evidence of harm to baby for breastfeeding when a mother is on anti-TNF.”

Knowing this about breastfeeding gives me great peace of mind as I continue the journey with my son, while still managing my Crohn’s by taking my Humira.

I also want to add that Dr. Mahadevan and her research team have been a huge support to me throughout the entire study. When she read a draft of this article and saw how I felt when I received the email with the blood results, she asked for recommendations about how to better deliver the findings to women. This meant a lot—I suggested sharing the range in blood concentration similar to how lab results are delivered on a patient portal and following up with an email or phone call to explain what the numbers mean further. Those touchpoints of support can make a big difference. I also shared my results over the patient portal with my GI and she called me to discuss them as well, which was helpful.

Interested in participating in the PIANO study? There’s always a need for more women to enroll! So far, 1,700 women have done so. There’s especially a need for women on newer drugs like Stelara, Entyvio, and Xeljanz. Click here to get involved.

Discovering the Root Cause: How a Patient Turned Physician Helps the IBD Community

This post is sponsored by Naturally Free from IBD—all thoughts and opinions are my own.

She’s a doctor with IBD who says her call to medicine began from her own hospital bed. Dr. Christina Campbell, DO, Certified Functional Medicine Physician, Board Certified Emergency Medicine was diagnosed with Crohn’s disease 40 years ago when she was only 12 years old. She’s utilized her own personal struggles and setbacks to guide the way she treats patients and helps others in our community. Through her own journey, she says many doctors left her feeling frightened, unmotivated, even angry. Christina learned early on about the importance of bed-side manner, compassionate care, and the gift of not only listening, but hearing what a patient is expressing. Her overarching goal—to be a physician who inspires faith, confidence, and a will to fight within her patients.

She’s dedicated her life’s work to facilitating and growing the value of a patient-physician partnership rather than what she calls a “DOCtatorship.” Christina believes that a personalized approach to health works better than recipe medicine, meaning she’s passionate about finding the root cause of disease and improving underlying health and the body’s biochemistry by intervening at the level of the root cause, through a functional medicine approach. Before we dig into the amazing work she’s doing, let’s take a walk down memory lane to see how Christina got to the point where she is today.

Christina’s Journey with Crohn’s

A diagnosis of IBD in 1983 looked a lot different than present day—and not for the better. When she was 14 years old, Christina faced a near death experience from extensive bleeding and lesions from her mouth to her anus. Her gastroenterologist said she had one of the worst cases of IBD he had ever seen and shared her case at global medical conferences and in case studies. Christina was averse to undergoing a complete colectomy and colostomy, so she underwent six months of bowel rest (nothing by mouth). She received all hydration and nutrition through an IV in her veins around her heart called a Hickman catheter. At the time, the only medications available for Crohn’s were Sulfasalazine and Prednisone. Can you imagine?! 

Since her diagnosis, Christina has been on many different medications through the years (Asacol, Delzicol, Sulfasalazine, any number of antibiotics, steroids, Toradol, Tylenol, Tylenol #3, Vicodin, Percocet, Compazine, Phenergan, Tigan, Tagamet, Pepcid, Bentyl.) When the first biologic was approved for treatment of Crohn’s (Remicade in 1998), she was in remission and graduating from medical school.

“My personal story is fraught with difficulties and each of my struggles has blessed me with a deep understanding of others and the ability to empathize and connect with patients. I have learned how to listen and really hear what they are saying. I have learned the power of creating a therapeutic partnership. My goal for each of my health participants is to match their lifespan to their health span. Quality of life alongside quantity of life is key. My personal journey has taught me that it only takes one step in a new direction to change the entire path of one’s life. It has also shown me the power of understanding your personal timeline. Looking back at our past journey helps us to understand the path that has led us to where we are,” Christina explains.

The Power of Responding to the Root Cause

Before Christina knew how to treat root cause issues and was solely utilizing conventional medicine, she says her immune system remained dysregulated. She was treating her symptoms with medications that acted like band-aides without addressing the cause.

“My functional medicine training has taught me the value of information and the concept that many with the same diagnosis may have completely different root causes. Utilizing detailed functional labs to discover altered biochemistry is an incredible tool to getting things back on track. These labs are not used in conventional medicine where the focus is on illness, not on wellness. It is a completely different perspective, which makes all the difference in helping someone find not just improved health, but optimal wellness.”

When it comes to discovering optimal wellness, Christina says this includes investigating genetics, epigenetics, metabolomics, oxidative stress, cellular energy and mitochondrial health, detoxification pathways, gut health and microbiome imbalances, inflammatory factors, and so much more.

“Once we uncover this information, we can begin to make changes personalized to your life, your body, your biochemistry, your genetics, your mind, and your spirit. Patience and grace with oneself are paramount to health as are understanding and forgiveness.”

The Transcend 3-step signature program

Christina works with IBD patients through her 3-step signature process to discover the root cause of symptoms, intervene at that level, revitalize health, and teach people how to maintain and excel for the rest of their lives. She uses natural and lifestyle interventions to create a personalized program which improves the health participant’s innate healing abilities to reverse symptoms, decrease pain, and improve all aspects of their lives.

“My Transcend program is my signature 3-step process which guides you through your precision blueprint for regenerating a healthy, joyful, vital you! This program is the culmination of 23 + years of medical expertise and 40 years’ experience as a Crohn’s disease patient. It is my passion project to help as many IBD patients as I can! I am on a mission to change the medical approach to Crohn’s and UC leading to fewer surgeries, stopping the path to health decline and disability by finding and fixing the root cause. We will Transcend IBD together living healthy vibrant lives.”

The process begins with uncovering your health history and detailing your timeline. Next, Christina works with patients to order specialized cutting-edge functional lab studies to help pinpoint where the most critical areas of intervention are needed. The third step is the Excel phase where you learn how to maintain these changes and continue to progress over time.

Connect with Christina

Facebook: Naturally Free From IBD

Instagram: @dr.christinacampbell

Educational Videos on Christina’s YouTube Channel

Website expected to go live October 2021: www.NaturallyFreeFromIBD.com

Upcoming Webinar September 1

Christina is hosting an online Zoom webinar September 1 at 7pm EST. By attending this webinar, you will learn three secrets for managing IBD and have an opportunity to ask questions. Tickets are $9.95 and limited in number. Get your ticket today!

Ready to Make a Change?

Set up an initial consultation here for men and here for women. Use coupon code Natalie20 for 20% off any time in 2021. HSA/FSA are applicable. This consultation is the first step to discovery. During this consultation you will discuss your body’s problematic areas as well as the areas where you are succeeding based on extensive intake paperwork and a 60-minute consultation. Potential interventions will be discussed, labs will be ordered, and a personalized care plan will be created.

Christina says, “I provide options for anyone who meets with me. However, I do not invite everyone into my signature 3-step Transcend program. It is important that we both feel we are a fit to work together to make this program successful. You must be ready to make the necessary changes and be open to new information. You must focus on progress and commit to never letting your self-doubt stop you from having what you want. There is hope! You can change your health and life for the better.”

“My dad and husband are both GI’s and I have Crohn’s disease”

Imagine having a dad who’s a gastroenterologist and a husband who is a GI fellow… and having Crohn’s disease. For 32-year-old, Lauren Gregory, that’s her reality. She was diagnosed with Crohn’s in 2008. Lauren is also a doctor herself and an IBD mom! When she’s not taking care of pediatric patients in the hospital, she’s enjoying time at home with her husband, Martin, and 6-month-old son, Connor. In light of Father’s Day, this week on Lights, Camera, Crohn’s, we share about how the most important men in Lauren’s life have helped her cope and overcome challenges IBD has presented along the way.

Through the eyes of Lauren’s dad

Late one night during Lauren’s college sophomore Christmas vacation from college, her mom called her dad with words he will never forget. She said, “Lauren is having terrible abdominal pain and is on the floor.” After a quick exam and seeing how tender and distended her abdomen were, he knew it was time to head to the closest emergency room. A CT scan showed massive gastric dilation and small bowel thickening. The surgeon was called, and he agreed it was likely Crohn’s.

Lauren was discharged home on a liquid diet with outpatient GI follow up after New Year’s. Unfortunately, her concerning symptoms persisted and her dad called a friend who was a gastroenterologist. He directly admitted her.

“When Lauren was admitted to Barnes Jewish Hospital in St. Louis while in college at Wash U, her then boyfriend (now husband) sat by her bedside for days as she underwent scopes and a small bowel series. We knew he was a keeper then. As parents we always worry about our children. As a gastroenterologist, we may worry more when our children have GI issues. We are fortunate to have connections in GI which allowed Lauren to have prompt evaluation and ultimately a great outcome,” said Dr. Bruce Waldholtz.

Navigating love and IBD

Lauren met Martin in college. At the time, he knew he wanted to be a doctor, but he did not know what he wanted to specialize in. During internal medicine residency, Martin was torn between cardiology and gastroenterology. He ended up choosing GI and is about to start a one-year fellowship to get extra training in IBD and nutrition. (Small World Fun Fact: He is part of the same GI practice I go to in St. Louis!)

Martin says Lauren inspired him to choose gastroenterology and specifically focus on inflammatory bowel disease.

“Watching her go through what she did at such an important time in her life was inspiring. I was so grateful to her doctors taking such good care of her. I wanted to be like them.  I wanted to help people like her succeed in living a rich, enjoyable, and rewarding life. “

Lauren feels incredibly lucky to have found someone as supportive as her husband. A month after they started dating, she was hospitalized with a partial small bowel obstruction. The fact he didn’t leave her side throughout that vulnerable and scary experience meant a lot to her.

When Lauren was hospitalized for one week during her fourth year of medical school, Martin was going through his second year of internal medicine residency. They were married, but in a long-distance relationship at the time.

“During residency you can’t just take days off, and it is challenging to find coverage. Because of this I did not expect him to be able to visit, but he somehow did. This flare occurred as I was transitioning from Humira to Stelara. I have been extremely fortunate to have stayed in remission since then (2017).

How personal life impacts professional life

“Without question Lauren makes me a better doctor, especially with taking care of IBD patients. I can understand the anxiety behind the questions they have about medications and what to expect because we went through the same thing as a family,” said Martin.

Lauren says her IBD has given her a unique outlook in how she cares for patients as well.

“My experiences with Crohn’s have made me more empathetic towards my patients, and now that I am a mom, I have much for empathy for my patients’ parents. Spending extra time with patients is not always easy given that I work mostly in the emergency room, but I make a point to take the time to listen to my patients and their parents’ concerns and provide reassurance when appropriate. In my marriage, my husband answers my medical questions and has a realistic perspective of what patients go through.”

Gratitude for her dad and husband

“I realize how fortunate I am to have a father (and now a husband too) who is a gastroenterologist who can answer my questions and to help me navigate our healthcare system, especially insurance! When my gastroenterologist decided I needed to start a biologic, and recommended Remicade, my dad pushed for Humira so that I wouldn’t have to worry about scheduling infusions around my college class schedule or worrying about transportation when I didn’t have a car. At the time I had no understanding of how having a chronic disease would affect my life.”