Pregnancy and Maternal Outcomes After Exposure to Risankizumab During Pregnancy: A Multi-Center Experience in the United States

Lay Summary There are limited data regarding pregnancy outcomes with maternal exposure to risankizumab, an anti–interleukin 23 (IL-23) medication approved for Crohn disease and ulcerative colitis. In this multicenter study we analyzed maternal and pregnancy outcomes among women exposed to risankizumab prior to and during pregnancy. Among 444 women exposed to risankizumab, fewer than 10 patients had adverse pregnancy outcomes, including abortion or miscarriage, small for gestational age, stillbirth, gestational hypertension, preeclampsia, placenta previa, cesarean delivery, postpartum hemorrhage, or preterm prelabor rupture of membranes. There were zero cases of preterm birth across all subgroups. This is the largest known sample evaluating outcomes of risankizumab-exposed pregnancies, and the data are reassuring that risankizumab is safe to administer prior to and during pregnancy, though additional longitudinal studies are warranted to further assess the safety profile of risankizumab in pregnant patients.