Patient Selection and Safety With TNF Inhibitors - Episode 13
Marla Dubinsky, MD: Research in the area of pregnancy and IBD [inflammatory bowel disease] is really exciting. One of the most important studies ever—and it will probably remain so—is something called the PIANO study, which is being led by Uma Mahadevan, MD, of UCSF [University of California, San Francisco] and is being funded through the Crohn’s & Colitis Foundation. This follows women who are pregnant and looks at the medications that they have received throughout pregnancy, even if they stopped treatment. The study looks at blood levels in the cord blood and in the serum of babies, as well as breast milk information, and it basically tracks the safety of medications for both the baby and the mom throughout pregnancy and during the postpartum period. I think that’s where we’ve gotten some relief of our anxieties. This has provided a lot of helpful information to the community at large, including patients.
Control of inflammation is important because disease activities probably affect a lot of outcomes, such as being worried about being small for gestational age, if they haven’t grown during pregnancy, and preterm labor. We’re looking at cesarean delivery versus vaginal delivery. We are looking at wound repair after cesarean delivery or vaginal delivery. Across the board, and even with exposure in the third trimester, which is the big question, disease does not determine outcomes of infection, which is probably the most important factor that everyone is really worried about—infections in the babies who are born exposed to these drugs that are, again, measurable in the cord blood.
There’s no denying that these drugs are measurable, except certolizumab. This has shown us that we could administer these drugs and keep women under good control during pregnancy. That’s a priority. We compared women who were exposed to biologics in the third trimester versus not. We saw the same outcomes. But the No 1 risk factor is flaring in the mother. If we go back to the common theme, if the mom flares, she has inflammation. That affects the baby.
We also showed that the development and the vaccine responses were not affected by exposure in the third trimester. If anything, those babies who were exposed to biologics actually had a slight point increasing the developmental milestone. I’m not saying these drugs make you smarter. It goes back, again, to the fact that control of inflammation is important.