Tag: Dr. Uma Mahadevan

PIANO 2.0: What women with IBD need to know about the latest pregnancy and postpartum research 

Leave a comment

When the Pregnancy Inflammatory Bowel Disease and Neonatal Outcomes (PIANO) study first launched in 2007 the main goal was to understand the safety of anti-TNF biologics like Humira and Remicade, and thiopurines for women throughout pregnancy and postpartum. As an IBD mom of three, I was able to participate with my youngest who is nearly 16 months old. The experience was something I am extremely grateful for. This incredible research for our community that is going on daily, helps guide decision making for treatment, while easing our fears as we embark on motherhood while managing IBD.

PIANO 2.0 is now underway and this week on Lights, Camera, Crohn’s I share everything you need to know about the updates to the ongoing research project, how you can participate, what the findings have shown thus far, and the goals for the future. Esteemed gastroenterologist, Dr. Uma Mahadevan, continues to lead the charge and help pave the way by sharing discoveries and findings.

“With new funding from the Helmsley Charitable Trust, we are really able to transform PIANO and try to reach a broader group of patients and answer more challenging questions. These questions include the safety of small molecules (tofacitinib, upadacitinib, ozanimod) and the newer biologics (ustekinumab, vedolizumab, risankizumab) as well as expand into studying the placenta and the impact of IBD, the response to COVID vaccine in pregnant IBD patients, and following children out to 18 years of age to look at long term safety and outcomes. The more you know, the more questions that come up.”

What’s new with PIANO

All women with IBD who are pregnant in the United States are invited to enroll. Specific interest in enrolling women on newer biologics (Stelara, Skyrizi, Entyvio, biosimilars) and small molecules (Xeljanz, Rinvoq, Zeposia) even if it was within 3 months of your last menstrual period but not during pregnancy. PIANO 2.0 is also expanding to look at the safety of aspirin in pregnancy (to reduce the pre-eclampsia rate) and well as how IBD women heal after a c-section and vaginal delivery.

There are new and improved patient and site interaction updates as well. There’s now a patient portal that enables women to enter their data directly, a Twitter page (@PIANOIBD) for research findings and updates, and a website with outcome data right at your fingertips.

The medical sites participating have also expanded to include USC, University of Miami, and the University of Maryland. Dr. Mahadevan says they realized most patients in PIANO were Caucasian and of higher socioeconomic status.

“We know pregnancy outcomes differ by race and socioeconomic status and we need to understand if that also applied to IBD pregnancies – does it make those differences more extreme or is there no impact? By expanding to sites with a far more diverse population, we will be able to better answer those questions.”

As far as the Patient Portal, rather than filling out paperwork and participating in phone interviews, now women simply answer questionnaires on the portal when they enter the study, every trimester, after delivery, at months 4, 9, and 12 of baby’s life and then once a year thereafter. Thanks to the Patient Portal, women can enroll remotely across the United States and don’t have to be at an IBD Center to participate.

Pushing the research further

The overarching goal with PIANO 2.0 is to gather data points from newer biologics and biosimilars and look at the safety of small molecules. So far, 2,012 women with IBD have participated in PIANO. The hope is to have at least 150 newly pregnant women participate each year. 

So grateful I was able to participate in the PIANO study during this pregnancy, with my youngest child, who is nearly 16 months.

“With biologics we generally feel they are all low risk as they won’t cross the placenta in the first trimester when the baby’s organs are forming. Small molecules, however, are more concerning as they will cross during that key period of organogenesis. However, for some women that is the only therapy that works, and they must make difficult decisions,” explained Dr. Mahadevan.

Once the baby is born, the research will look at if the child develops any infection issues, malignancies, neurological issues, and immune diseases like IBD. There are some questions about basic diet as well. Having long-term data and a fuller picture of the future for IBD moms is priceless. By participating we’re truly paving the way for IBD moms now and in the future.

Dr. Rishika Chugh recently shared a presentation at the American College of Gastroenterology conference that Dr. Mahadevan co-authored that looked at data on 47 women on Stelara (ustekinumab) and 66 on Entyvio (vedolizumab). Those women were compared to moms not on biologics/thiopurines and those on anti-TNF therapies. 

 “There was no increase in harm from being on Stelara or Entyvio compared to those groups. Interestingly, those on Stelara had lower rates of preterm birth and C section. Numerically, there were also less infections on Stelara though that was not statistically significant.”

Participate in a Townhall Discussion with Dr. Mahadevan: Starting a Family with IBD: What Men and Women with IBD Should Know about Conception and Pregnancy

Save the date for a discussion taking place Thursday, December 15 at 6:30 pm Pacific Time. Click here to register for the free event.

Click here to enroll in PIANO 2.0

Follow the latest on PIANO 2.0 on Twitter.

Check out the new website. 

I’m excited to be serving as one of the IBD patient advisors on the project, alongside fellow IBD moms Jessica Caron, Brooke Abbott and Amber Tresca (from IBD moms). We’re looking forward to providing the patient perspective and helping to guide the conversation. Jess and I were on biologics in pregnancy and have previously participated in PIANO. I had the opportunity to participate in IBD research studies with all three of my kids and it’s extremely empowering to know you are helping to change the future of care for women in our community and providing women with the added support we need while navigating pregnancy and motherhood with a chronic illness.

Participating in PIANO: Why I choose to be a part of research while pregnant and beyond

Leave a comment

As an IBD mom I see it as a responsibility and an opportunity to participate in research studies while I am pregnant and as my children grow. I’m currently 20 weeks pregnant (tomorrow!) with my third baby and this time around I’m enrolled in the Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes (PIANO) study. The project was conceived, lead, and executed by Dr. Uma Mahadevan, Professor of Medicine at the University of California San Francisco in 2007.

Since the project launched, more than 1,800 women have participated in the registry. Of that number, over 900 stayed on biologics throughout their pregnancies. I’m thrilled to be a part of this initiative. If my pregnancies and children can provide clarity for a future generation of IBD moms, the extra effort on my part is more than worth it. Thanks to women before me who have been on a biologic and been a part of research while pregnant, I have peace of mind knowing that staying on my Humira is best for me and for baby.

Without studies that indicate how babies in utero respond to medication exposures we would be in the dark about what is best for mom and baby not only during pregnancy, but with breastfeeding.

“There is so much misinformation about pregnancy and IBD including being told not to conceive at all or to stop medication. This is incorrect and dangerous. PIANO was started to provide reliable data for women with IBD considering pregnancy so they and their providers can make an informed choice for themselves and their babies,” said Dr. Mahadevan. “Every pregnant woman with IBD has benefited from the generosity of PIANO moms who contributed their outcomes, good or bad, to the pool of knowledge we have. Every PIANO mom who contributes benefits not herself, but future mothers with IBD. It is an invaluable and precious gift.”

What PIANO measures

There are four main areas the PIANO study looks at:

  1. Whether the level of biologic drug transferred across the placenta to the infant by the time of birth predicts the risk of infection or other adverse outcomes
  2. Whether the achievement of developmental milestones is affected by medication exposure
  3. Whether the rates of birth defects, adverse pregnancy outcomes and complications of labor and delivery are affected by IBD medications
  4. Whether second trimester drug levels can be used to adjust drug and minimize transfer across the placenta to the baby

Since I am just now reaching the halfway point of my pregnancy, I have only had to fill out questionnaires. You are required to do so during each trimester, at the end of your pregnancy, and then at 4, 9, and 12 months post-delivery. Along with that, you can provide follow up until your child is 18, once a year. During this trimester I will also provide blood work and a fecal calprotectin. On delivery day, bloodwork will be taken from me, my baby, and my umbilical cord. Depending on my son’s blood work at delivery, I may be asked for more when he’s 3 and 6 months. If at any time I am not comfortable with him getting his blood drawn, I can always opt out. The cord blood is similar to the baby blood at birth so that is adequate. I can also choose to stop the annual questionnaire at any time.

If a woman receives the COVID-19 vaccine during pregnancy, the PIANO study is also measuring the antibody levels found in the cord blood (on the day of birth) to confirm that the benefit transfers to the baby. Breastmilk will also be measured for the transfer of protective antibody against COVID.

The Findings Thus Far

In a presentation this past fall, Dr. Mahadevan shared findings from PIANO.

“We looked at pregnancy, birth and developmental outcomes in the infants at one year, based on exposure to drug, and found no increase in negative outcomes and no reduction in developmental milestones. Biologic‑exposed infants did have some statistically increased improvement in developmental milestones compared to the unexposed group. Overall, what this study suggests is that women with inflammatory bowel disease should continue their biologics and thiopurines throughout pregnancy to maintain remission, given no evidence of harm, and evidence that  disease activity can increase miscarriage.”

The study also found that disease activity can increase preterm labor and birth, all the more reason for women to stay on their medication and not try and go med-free while pregnant.

Looking to the Future

Currently, there is no end date for the study. As long as there is funding, the project will continue. Dr. Mahadevan says with all the new medications coming down the pipeline there is a need for safety data. She says, “The infrastructure of PIANO allows us to study new medications as they come to market, even before they are approved for IBD.”

To participate in the study women must have IBD and live in the United States. Interested in learning more or getting enrolled? Email PIANO@ucsf.edu or call 415-885-3734.