Inflammatory bowel disease (IBD)—including Crohn’s disease, ulcerative colitis, and indeterminate or unclassifiable colitis—is a condition characterized by inflammation of the intestine of unknown cause. IBD is often diagnosed during the reproductive years; therefore, it is important for physicians caring for these patients to be able to adequately address questions regarding the potential risks that medications used to treat IBD may pose to the child’s development.
In general, most drugs used to treat IBD, such as corticosteroids or aminosalicylates, are not associated with risks to the child. However, the safety of administering other medications during pregnancy is more controversial. In particular, the safety of newer biologic agents (mainly vedolizumab, ustekinumab, risankizumab, mirikizumab, and guselkumab, among others) and small molecules (tofacitinib, filgotinib, upadacitinib, ozanimod, and etrasimod) has been little studied.
Through the present study, we aim to assess pregnancy outcomes and the development of children up to 4 years of age according to the medications received by the mother.
STUDY DESIGN:
This is an observational, multicenter, non-interventional study evaluating the safety of newly approved treatments for IBD during pregnancy, breastfeeding, and the first 4 years of the child’s life.
OBJECTIVES:
Primary objective:
To evaluate the safety of new treatments used to treat IBD (non–anti-TNF therapies and small molecules) during pregnancy and the first 4 years of the newborn’s life, focusing on the risk of developing severe infections.
Secondary objectives:
To determine the risk of serious adverse events during pregnancy and delivery associated with new therapies used to treat IBD.
To evaluate the development of children born to mothers exposed to new treatments during the first 4 years of life.
To compare the relative risk of serious adverse events in children born to mothers exposed in utero to new treatments with that of children not.