Marla Dubinsky, MD, on the PIANO Study of Pregnancy in IBD

Dr Dubinsky discusses the findings of the PIANO study confirming that control of inflammatory bowel disease in pregnancy is the key to optimal outcomes. She presented this talk at the Advances in Inflammatory Bowel Diseases 2021 virtual regional meeting on March 6.

Marla Dubinsky, MD, is a professor and codirector of the Susan and Leonard Feinstein IBD Center at the Icahn School of Medicine at Mount Sinai in New York City.

Hello, I'm Dr. Marla Dubinsky, and I had the pleasure of speaking about the lessons we learned from the PIANO study at the Advances in Inflammatory Bowel Disease meeting today. I wanted to talk to you about all the amazing stuff we've learned through the PIANO study.

We know that we needed good prospective information so that we can educate physicians and patients on the outcomes of babies born to moms who were exposed to different IBD therapies.

There's always the two biggest fears that we get asked a lot of questions around from patients is, "Will my medications impact my baby? Is it safe for me to be on these therapies during pregnancy? Conversely, what if I flare during pregnancy, and how that will affect my pregnancy and my baby's outcome?"

I want to remind everybody that PIANO, which has over 1,000 women that were prospectively followed, were essentially grouped into those women who were exposed to biologics, either as monotherapy or in combination with immunomodulator, or an immunomodulator alone, versus women who were not exposed to either the biologics or immunomodulators.

There were about 379 women in the nonexposed group, 242 in the immunomodulators alone, 642 in the biologics alone, and 227 in the combination of the biologic with an immunomodulator.

The most important thing and the message I wanted to get across today was that being exposed to any of these therapies did not increase the risk of infections in the babies, did not increase or have any impact on congenital malformations, did not increase spontaneous abortions.

We did not see an increased rate of preterm birth, and we did see increase in infections only in those babies that were actually preterm.

One thing that is very important to understand is that the key message was that uncontrolled disease activity, which often would come from stopping therapies, for example, or being too scared for patients to continue on these therapies, and then women would be flaring.

The presence of disease activity was one of the most important things to come out is that that was associated with an increased rate of spontaneous abortion. We also saw that exposure to these therapies was not associated with developmental milestones as measured at 12 months.

Their developmental skills were not impacted by exposure. At the end of the day, the important thing to remember is that if the mom is good, meaning her inflammation is well-controlled and she is doing well on these therapies, it is very important that we do not stop these therapies.

Now our recommendations are that you could treat straight through into the third trimester.

Now recognizing you'll hear a lot of different information that some of us are stopping it around week 30, week 32, if we had the luxury of having every-8-week infusions, for example, we would time it that they would get it immediately after delivery, so that you can have that 8-week period in the last trimester, where the mom is not coming in for therapies.

If a mother is on every 4 weeks, or she's on an every 2-week injection, or an every week injection, for example, it's important that the mom is treated. I think first and foremost is take care of the mother.

We do not have evidence to suggest that exposure is impacting the baby's outcomes. If anything, it's the converse that if the mom has increased disease activity, she actually has a higher rate of spontaneous abortion.

My takeaway is that I was very excited to see the prospect of data that we have from PIANO, and it provided some good reassurance for both us as providers and to patients. Thank you.