Tag: IBD advocate

My Key Takeaways from the FDA Workshop: “Evaluating Immunosuppressive Effects of In Utero Exposure to Drugs and Biologic Products”

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More than 4 million babies are born in the United States each year, many to mothers who live with chronic illness. Historically, pregnant women are excluded from research, consequently there is limited to no safety data at the time of drug approval. Enormous gaps remain regarding the clinical impact of exposure to biologics and medications when so much is at stake for both mom and baby. July 11-12th the Food and Drug Administration (FDA) hosted a public workshop entitled, “Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products.”

As a patient leader in the IBD community and mom of three children who were all exposed to anti-TNF medication in pregnancy, I was invited to provide the patient voice during this two-day discussion. I spoke on three different panels to share my perspective. This week on Lights, Camera, Crohn’s I’ll share what I learned and what I heard from top researchers and doctors at the workshop. The key overall message—healthy moms lead to healthy babies and a healthy society. Healthy meaning—having disease well-controlled in pregnancy so flares don’t lead to adverse outcomes for both mom and baby.

Pregnant women and lack of research

Often due to ethics, pregnant women have been omitted from research and clinical trials. The absence of human involvement in pharmacology studies can lead to uncertainty about what is deemed “low risk” and “safe” to the fetus, and the impact medications have on the placenta. Women who become pregnant must drop out of clinical studies, even if the drug class has known safety or is deemed low risk (anti-TNF, IL-23s).

According to study entitled, “Medication use during pregnancy with a particular focus on prescription drugs”, Pregnant women report taking an average of 2.6 medications at any time during pregnancy. Medication use may expose the fetus and infant to the medication through placental transfer.

It’s clear that reducing or stopping medications can put mothers at risk for flares, which in turn can lead to adverse effects in pregnancy. With my own children, I stayed on Humira until 39 weeks with my oldest (who is now 7), and 37 weeks with my other two children (who are now 5 and 3). All three of my children were a part of pregnancy studies (MotherToBaby and PIANO). My youngest will be followed until age 18! My oldest was followed through kindergarten. The current recommendation, globally (which has changed since I had my children) is to keep women on biologics throughout the entire pregnancy.

One of the key areas of discussion is whether animal data from research ever tells us the whole story about the safety and efficacy of medications—the answer is no. There is no substitute for a human placenta, but the challenge and dilemma are what can be done to get this human data. Approaching clinical trials in pregnant women is challenging and takes time to develop. Currently, animals are the best tool we have for educated guesses.

The benefit vs. risk discussion for Mom and Baby

Oftentimes decision making with chronic illness is a risk versus benefit thought process, whether you are pregnant or plan to carry a baby in the future or not. During the FDA workshop, there was an incredible presentation that really resonated with me about the multiple decisions women have to make for both themselves and their unborn children. The discussion highlighted the complexity and why it’s not a black and white decision. These series of decisions are nested in each other and revolve around the decision maker (Mom/Dad) and medical providers.

Key considerations we deal with as IBD moms:

Continue or discontinue medication?

Should we breastfeed on medication?

Should we give an attenuated live vaccine as scheduled or delay?

When making these decisions it’s imperative that patients feel heard and that communication take place between the parents and medical providers (gastroenterologist, maternal fetal medicine, and OBGYN). Knowledge is power and educating yourself going into these conversations and before and during pregnancy can make you feel more empowered in your decisions.

The power of the placenta

There were placentalogists at the workshop—yes, those exist!! And it was amazing to learn how dynamic the placenta is and how it changes throughout pregnancy. The placenta is not just a conduit, its function changes across gestation and with fetal sex and medical condition. It serves as the endocrine function, lungs, pituitary, drug processing center, neuro connections, and growth factors for the baby…to name a few.

For instance, according to this study, there are differing levels of placental chemokines and cytokines and even reduction of placental antibody transfer in male placentas.

Once the placenta is impacted it effects the fetus. There was also discussion about how Inflammatory Bowel Disease impacts placenta—and the possibility of looking at the placenta of an IBD women at delivery to compare them to women without the disease. Even when a woman has well-controlled disease or is in remission, it’s believed our placentas may appear differently at delivery due to the inflammatory nature of our disease. I joked during on one of the speaking panels that I would have gladly given all my placentas to research upon delivery! It’s  win-win for researchers and patients alike to do so.

Medication safety in pregnancy

There was also discussion about the importance of developing medications that are safer in pregnancy, much like children’s medications are created with a different formulation.

Prednisone causes minimal fetal exposure. Solumedrol at infusions is fine, and it’s ok to breastfeed on steroids, but high dose daily oral steroid can cause cleft palate and cleft lip.

Azathioprine has also been found to have no impact on breastfeeding, babies born to moms on Azathioprine have normal development and they do not have increased susceptibility to infection.

A graph outlined a study that looked at 107 pregnant women with IBD on Infliximab/Adalimumab:

Detectable anti-TNF levels after birth:

3 months of age—94%

6 months of age—23%

9 months of age—7%

12 months of age—3%

This illustrates why babies exposed to anti-TNF after believed to be immunocompromised until 6 months of age.

Vaccine response and impact of immunosuppressive medications

It is believed that women on immunomodulating medication who get the TDAP vaccination in pregnancy have the same immune response as healthy controls and that the baby receives the same benefits.

The recommendation for Rotavirus (which is the only live vaccine given the first 6 months of a baby’s life), is now to give this vaccine to babies. This updated guidance also applies even when babies are exposed to anti-TNF or immunosuppressive medications in pregnancy.

There’s no difference in vaccine response for babies across different biologics.

Limiting the burden on mom and baby in pregnancy and postpartum studies

Once babies are born and they are part of research studies to measure how their exposure in utero impacts or does not impact their future health, there’s often a burden on the mother about following up. As an IBD mom myself, I wasn’t big on having my babies get blood draws for medical studies—but that data is paramount in helping further that research. And knowing what I know now, I wish I would have been more willing to do so.

So how can studies ease this burden and stress on families?

This can be done by having well-trained phlebotomists who have experience working with children and using techniques to optimize venipuncture success to limit discomfort and pain. By timing blood draws for research at the same time of doctor’s appointments, it reduces the number of needle sticks and blood draws.

Dr. Mahadevan’s Presentation at the workshop

One of my favorite presentations was given by Dr. Uma Mahadevan. She is the key investigator of the PIANO (Pregnancy Inflammatory bowel disease and Neonatal Outcomes), and a well-respected gastroenterologist at UCSF. PIANO started in 2007 and looks at the safety of IBD medications on the pregnancy and short-and-long term outcomes of children. My youngest son is part of PIANO. We participated throughout pregnancy, provided cord blood from delivery, as well as blood draws. I just submitted his 3-year forms online.

I recorded Dr. Mahadevan’s presentation and have transcribed everything she said below so you could hear her expertise firsthand:

“Women of childbearing age—women of reproductive potential are not given JAK inhibitors—even though it may be the most effective medication for them. This is a result of fear—that maybe they’ll get pregnant and maybe there will be some harm. Medications with well-established safety records like anti-TNFs are discontinued in pregnancy now—68% of women who go off their anti-TNF did so from the advice for their rheumatologist, so these are the doctors telling them to do this.

What’s the importance of treating immune mediated disease in pregnancy?

Disease activity is the biggest driver of adverse outcomes in pregnancy. Women with IBD compared to general population have an increased risk of spontaneous abortion, pre-term birth, small for gestational age, hypertensive disorders of pregnancy including preeclampsia , post-partum hemorrhage, and 44% rate of C-section, most of them elective out of fear of disease.

Stopping the biologic which again is out of fear—you’re on a biologic, it’s stopped in pregnancy, still is in many rheumatology and psoriasis cases, less so with IBD, but when you stop it…reducing or stopping leads to an increase of disease flare.

Many of my colleagues who are rheumatologists say “oh many with rheumatoid arthritis get better in pregnancy…there is not a single study that shows that. In fact, this study from The National Inpatient Samples shows women with rheumatoid arthritis were more likely to develop complications of pregnancy both during pregnancy, but also in post-partum and in their neonates.

The American College of Rheumatology conditionally recommended continuing anti-TNF during pregnancy despite the available safety data and the voting panel agreed that if the patient’s disease is under control these medicines can be discontinued. This is happening now.

In this article from a prospective registry from Sweden and Denmark that looked at 1700 patients with RA, there was increase in pre-term birth and small for gestational age in RA compared to the general population and that odds ratio increased to three-fold with active disease.

So, there is data that it increases harm in not just IBD but RA as well. We know there’s a strong role for inflammation in pregnancy and in pregnancy outcomes. So, the significant increase in pregnancy and neonatal complications is closely linked to disease activity and inflammation and stopping these low-risk meds and steroid sparing therapies lead to increased suffering for the mother, and post-partum flares and worst outcomes for the infant.

Healthy mother=Healthy Baby

So, what are some of the study designs and limitations-these have been brought up before. Pregnant women are not included in clinical trials. There’s unmeasured confounding in uncontrolled studies. Disease activity impacts the decision to continue or discontinue therapy. It’s not random. The choice of therapy is not random it is linked to their disease severity and what they have.

If you have a series of 100 patients or 1000 patients or 10,000 patients, you may not pick up the signal. The types of studies that are used for the most part are large data sets, so birds eye view and the highest quality study are large population studies from countries in Scandinavia usually where they have longitudinal assessment, parent-child linkage, and a good assessment of diagnosis in pregnancy outcomes. However, these are limited by a fair assessment of medication because they can only measure prescription and not whether the patient is actually taking the medicine. At a very poor assessment of disease activity and very granular data.

People are more likely to report a complication than a healthy pregnancy—incomplete info.

Let me tell you about PIANO—this is a prospective national registry of pregnant women with IBD started in 2007. PIANO divides people into four groups:

  • The unexposed—which could include people on steroids, 5 ASAS, antibiotics.
  • Thiopurines: Azathioprine, 6-mercaptop, urine
  • Biologics: Infliximab, Adalimumab, Certolizumab, Natalizumab
  • Combination Therapy: Azathioprine + Biologic

We define exposure as anytime within 3 months of conception through pregnancy. We compare the offspring of women exposed to a medication to offspring of women with IBD who have not been exposed. We looked at multiple different outcomes including pregnancy and neonatal outcomes , we administered questionnaires each trimester of pregnancy, three times in the first year of birth and then annually and we continue to follow these patients out to age 18.

So, here’s some of the data that has been published:

Corticosteroids –I often hear from providers, “oh I’ll just stop their medication and if they flare, we’ll give them steroids.” This actually leads to increase rates of pre-term birth, low birth weight, and NICU admission. Of course, the use of steroids is mostly tied to disease activity. It’s hard to separate the two. But the whole point is that you don’t want disease activity, you don’t want steroid use, you want them to be on a steroid sparring effective therapy.

The primary results of PIANO were published in 2021 in Gastro. We looked at 1,400 IBD pregnancies, 379 were not on drugs, 242 were on thiopurine, 642 were on biologics (Primarily anti-TNF), and 227 were on both biologic and thiopurines so about 1,000 biologic exposed pregnancies. We found no increase in birth defects, spontaneous abortion, preterm birth, low birth weight, or infections in the first year of life. We saw an increase in spontaneous abortion with disease activity and we used the Ages and Stages questionnaires to look at developmental milestones and saw no reduction.

We measured placental transfer and we measured maternal and cord blood for inflammation on day of birth. The highest transfer was with infliximab—the lowest was certolizumab, which doesn’t have the FC portion. Vedolizumab had a lower level in the infant than the mother. When this data first came out the first reaction was – “oh we should stop the biologic early”…so in Europe they have more of a glass is half empty look at medications in pregnancy…US tends to be glass is half full. So, they decided to stop at 22 weeks and that was in their official guidance. And it was not until 2 years ago that that was changed to match US recommendations because their own data showed an increase in disease activity and worse outcomes with doing that.

The concern was if you have this placental transfer, if you have therapeutic drug levels in the infant for several months after birth, do they have higher rates of infection? And we showed in PIANO there is no increase in infection at 4 months of age and at 1 year and we looked at if infection rates were relative to the level of drug in the infant at the time of birth, and there was no association to drug level at birth and recent infection.

So based on that now, we don’t stop the biologic at all during pregnancy, we continue it throughout. A systematic review and meta-analysis looking at 8,000 women with IBD who were exposed to biologics showed no increase in infant infections, antibiotic—- showing that biologics do not cause harm.

This data from Antoine Meyer who uses a French patient sample looked at women on anti-TNF and thiopurines and showed no increase in the risk of early life malignancy in children.

We ask about infection—we ask about immune suppression—we ask about malignancy and so far in these 3700 thiopurines and 3400 anti-TNFs from 3 years of age going out to 11 years of age, no increase. Very reassuring data.

PIANO looks at developmental milestones—out to 12 months and up to 4 years—shows no decline, we actually showed patients on TNF had statistically superior developmental milestones in every category compared to the national average and even within PIANO—not to say that TNF’s make your kid smarter…but the whole idea of controlling inflammation is what allows these kids to lay down their neural pathways.

What about the newer biologics?

Ustekinumab and Vedolizumab—again showing no increase in harm for both pregnancy and infant outcomes.

Antoine Meyer again from the French database looked at 398 vedolizumab pregnancies, 464 Ustekinumab pregnancies…again, no increase in harm for all these important outcomes.

It’s not just congenital malformations, what else can happen with these medications?

We’re working with Susan Fisher who is a placental scientist at UCSF, a question was raised about Vedolizumab inhibits alpha 4 beta 7, which can inhibit MAdCAM, which is involved in the process of plasmatation—so if you inhibit MAdCAM are you going to have issues in plasmatation. This was just a pilot study. The first one here the patient also had pulmonary hypertension—this is a normal placental at birth…you can see how this looks distinctly abnormal. The second patient was born 39 weeks, mother was completely healthy with her UC had no other issues during pregnancy. Compared to normal placenta…so are there other things we are missing here?

We are conducting a larger study now with multiple biologics the question is it’s not the Vedolizumab is my hypothesis, it’s more a result of inflammation, having IBD…but it will be interesting to see what these placentas look like when we finish. But maybe this is why these patients have higher rates of preeclampsia, higher rates of hypertensive disorders in pregnancy, and preterm birth. It may be related to the impact of inflammation on the placenta.

Small molecules—I feel very comfortable when a new biologic comes out to continue in pregnancy, I feel reassured by the minimal to lack of transfer in the first 14-16 weeks of gestation, with small molecules—they will transfer and Tofacitinib showed teratogenicity at super therapeutic doses, Upadacitinib showed teratogenicity at the doses we use in humans at 30 mg daily—so that does raise concern. There is now some data, again from clinical programs—no increase in birth defects, in pregnancy loss.

Same for –in press—looking at Upadacitinib …128 maternal exposed pregnancies, 80 of which were in clinical trials…similar rates of live births, spontaneous abortion, compared to what is expected.

What about breastmilk? In PIANO, we do collect samples and found the amount of transfer was really miniscule. But all biologics had transfer—we found no increase rates of infection or impact on developmental milestones with patients who were breastfed while the mother was on an immunomodulator.

We talked about vaccines—if these patients had detectable level of biologics—the first 6 months of life will they have normal response to vaccines? We looked at Tetanus — and found the rates of response were similar to infants of mothers who were not exposed to biologics…that was reassuring. We had 40 inadvertent Rotavirus exposures in our TNF babies, they did just fine. This has also been shown in European data as well. And I want to make sure you are all aware of the study from Lancet looking at Rotavirus vaccine—this was a prospective study looking at infants exposed to biologics, they gave 168 biologic exposed infants Rotavirus vaccine—can only be given the first 3-4 months of life, after 6 months it’s not given—so if you say no in the first 6 months, baby never gets it. They found no harm—at this point, we are letting patients on TNF get Rotavirus vaccine, you can argue the US and most areas because of herd immunity, Rotavirus may not be that important, but in other parts of the world it is—and it’s fine to give to patients exposed.

BCG vaccine is different—especially in an anti-TNF exposed baby, it does have a higher rate of TB, having to do with mechanism. There was one death in a European study given vaccine at 1 month of age. BCG can be given after 6 months of age. So Rotavirus is fine within 6 months, but BCG is still recommended after 6 months.

MMR in high-risk populations can be given at 6 months—why did the Europeans, Asians, and Americans have such different guidelines? This May (2024) we all got together for the Global Consensus Conference to create one standard for pregnant women globally and to help spread the word.

Our recommendations are to continue 5ASA, continue sulfasalazine, continue steroids when necessary, stop methotrexate, and continue thiopurine, continue anti-TNF therapy. The US and Europe agree we will not be stopping TNF early, we will continue it on schedule. We’ll continue vedolizumab and ustekinumabon on schedule, and it’s ok to start these medications in the middle of pregnancy.

Biosimilars have equal safety as originator. The Europeans didn’t understand why we wanted to include this, but this is a common question that comes up in the US. We consider biosimilars safety to be equal to the originator drug.

IL-23 therapies… even though not well studied, we feel based on mechanism they can be continued.

Small molecules should be discontinued—but particularly for the JAKS though, unless there is no effective alternative, they can stay on them. I have had patients where they have to stay on Tofacitinib and Upadacitinib because there was nothing else that worked for them.

Inactive vaccines should be given on schedule. we suggest live rotavirus can be given to children exposed to anti-TNF and recommend BCG be avoided in the first six months.

Final thoughts

A recording of this two-day FDA workshop will be available online in the next two weeks. I will share the link as soon as it becomes available. on my Instagram (natalieannhayden). There were fantastic discussions and as an IBD mom who has gone through pregnancies while on a biologic I am grateful for the consideration and the research that’s going on to help couples feel more confident and at ease about bringing life into this world while juggling complicated health conditions. The conversations and presentations at the workshop were extremely complex, I did my best to translate the information, so the patient community has a better grasp of where we stand about IBD pregnancy research.

If you have IBD and are planning to be a mom or if you are currently pregnant, please consider joining the PIANO study and being a part of this life-changing research for our community.

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

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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

12 years on a biologic: What I’ve learned along the way

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It’s been 12 years since I apprehensively went to my GI’s office with my mom, trembling in fear about the what ifs and worrying about the pain of the injection and how my body would respond. One dozen years ago I threw caution to the wind and knew I needed to take the leap. I trusted my physician. There was no other choice. I knew I needed more to control my Crohn’s. I realized my quality of life depended on it. My present life and my future deserved more. IMG-4785

I wish I could tell that frightened 24-year-old girl that a biologic would enable her to fulfill her dream of working full-time in television, that she would go years between hospitalizations, that she would meet the love of her life, travel out of the country, and have two healthy children…all while on a biologic.

This week—I share my 12 tips for navigating life on a biologic and what I wish I knew 12 years ago today.

  1. Needing medication is not a failure. Not everyone has the luxury of being able to “heal their gut” solely with food and that is ok. You are not less than because you need to be on a biologic. You are not giving up or taking the easy way out.
  2. Side effects are unique to each person. Just because one person responded beautifully to a biologic, doesn’t mean that you will. The same goes with horrible side effects. One person’s experience has nothing to do with yours. IBD is unique in each one of us. While some people get a “Humira hangover” and are in pain leading up to their injection, others like me, deal with no side effects whatsoever. Don’t base your experience off anyone but your own and remember to consider the benefit vs. the risk.
  3. Google is not your friend. Prior to starting a biologic or when you are on one, it does you no good to Google and read all the doomsday laundry lists of “what ifs” and horror stories. If you want to educate yourself and truly learn more, communicate with your physicians and connect with fellow IBD patients who understand your reality.
  4. The drug fails you; you don’t fail the drug. Time and time again, I see patients say… “I failed Remicade. I failed Stelara. I failed Entyvio. I failed Humira.” You did not fail anything. This is not a blame game and how your body responds to biologics is completely out of your hands. If a drug doesn’t help limit inflammation and control disease progression, it fails you and you move on to the next.
  5. Have a routine and be compliant. Life gets hectic and being on a biologic must become a part of your routine. It’s helpful to keep track on a calendar or to set up an alert on your phone. I’m old school and write R or L in my day planner…meaning “Right Leg” or “Left Leg”…you’d be surprised, you won’t remember which leg you last injected two weeks ago. I’ve done my Humira injections on Mondays since 2008. I’ve always liked that day of the week because it doesn’t interfere with the weekend and I get it out of the way. No one likes Mondays anyways. Biologics aren’t just something you skip or can forget like a daily multivitamin. For the drug to work you must be compliant and stay on schedule.
  6. You can get pregnant and breastfeed while on a biologic. The most common question I receive from women with IBD is “can I get pregnant on my biologic?” and “can I breastfeed?” …the answer to both of those is a resounding YES. To safely bring a baby into this world, the mama’s health must come first. You need to be a safe haven for your baby and keep your IBD well-managed. By going off your medication, you put yourself at much greater risk for flaring while pregnant and after you deliver. I was on Humira until 39 weeks with my son and 37 weeks with my daughter. To learn more about biologics and family planning check out the IBD Parenthood Project and IBD Moms. IMG_6037
  7. Communicate openly with your GI. Check trough levels every now and then, especially when you’re feeling symptomatic to see if your drug level is therapeutic, if your dose needs to be increased, or if you’ve built up antibodies and need to possibly start a different biologic.
  8. Think about your lifestyle if you’re having trouble deciding which biologic to try. Back when I started Humira in 2008, there were only two biologics for IBD on the market: Remicade and Humira. At the time, I was a morning news anchor and did not share my Crohn’s disease with the public—so choosing to do an injection in the comfort of my home vs. being in public getting an infusion was a no-brainer. Now as a mom of two, I’m grateful for that choice. You can’t beat the convenience of being able to do a 10 second injection on your couch. I have so many friends who spend hours upon hours getting an infusion—having the stress of lining up childcare and allocating that much time and resources to get my medication would be a struggle for me. Let alone needing to get an IV…I know I’m not alone when it comes to having bad veins! I understand you need to go with what your body responds best to and what your physician recommends for treatment…but if the decision rests on your shoulders, I would absolutely choose injection over infusion.

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    Injections at home make chronic illness mom life a bit easier.

  9. Consider yourself “lucky” if you’re starting Humira now. The first 10+ years I was on Humira the injection was very painful. I know of people who had to take anti-anxiety meds just to feel comfortable receiving the injection. In 2018, the Citrate-free (pain free) version was released in the United States. Click here to watch my emotional experience doing an injection with the pain-free formula for the first time, while pregnant. This has been a game-changer for everyone on Humira, young and old. Self-injecting takes some getting used to, but it’s a hell of a lot easier now that you don’t have to deal with any pain. Chalk this up as a big win for the patient community—and if you haven’t made the switch to Citrate-free yet, make sure you do now!
  10. Drown out the Debbie Downers and the naysayers. You are going to come across friends and family who most likely have good intentions…but will question your decision to be on a biologic and offer useless, worrisome advice or stories of their friend’s friend who died from lymphoma or their boyfriend’s dad who had a bad reaction. I remember people questioning me about being on Humira when we were starting our family. We’re already worried enough, having to deal with the background noise can be the biggest pain of all.
  11. Be inspired by the possibilities. We’re all quick to expect the worse or struggle to imagine a life that doesn’t involve daily setbacks. Think of all the good that can come of this and the quality of life the medication can afford you with. Be patient with your body. Be patient with the drug. Be patient with yourself on this journey.
  12. Get preventative screenings. Stay on top of your appointments outside of your gastroenterologist. See your Ob-Gyn and get annual pap smears. See your dentist every six months. See a dermatologist and get an annual full body screening. Talk with your GI about getting “safety labs” every three months to keep a close eye on your results and make sure nothing is out of whack. See an eye doctor annually, even if you think you have perfect vision. Steroids can cause cataracts and IBD can cause inflammation around the eye. If your child has IBD, make sure to stay on top of pediatrician appointments. Being well-informed about all aspects of your health helps protect you from falling victim to any serious side effects.

BONUS: Reward yourself. Let’s face it. Giving yourself an injection or getting an infusion is not the most enjoyable experience. Think about how you can treat yourself when it’s over. Get some ice cream. Get a manicure. Order that cute pajama set online. Lord knows, you’ve earned it. If you struggle self-injecting, stare at a photo of a family member or friend that exudes strength and resilience, they will inspire you to be strong.

I’m not sure what the next 12 years will bring. Will Humira continue to be my go-to? Will there be a different treatment option? Only time will tell, but for now, I’m incredibly grateful that I’ve been able to stay on the same course of treatment for this long and I don’t plan on doing anything to rock the boat. My wish for you is that you’ll find a treatment that works its magic and shows you all that you’re capable of, despite your IBD.