Journal Article

Outcomes of Pregnancies With Maternal/Paternal Exposure in the Tofacitinib Safety Databases for Ulcerative Colitis

Graham, Daniela, Jones, Thomas V, Mahadevan, Uma, Lawendy, Nervin, Clowse, Megan E B, Dubinsky, Marla C, Su, Chinyu, Zhang, Haiying, Baumgart, Daniel C, Feldman, Steven R, Marren, Amy

2018

Overview

Abstract Background Active inflammatory bowel disease increases the risk of adverse pregnancy outcomes. Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). As a small molecule, tofacitinib is likely to cross the placental barrier; however, information on the effects of tofacitinib on pregnancy outcomes is limited. We report pregnancy and newborn outcomes among patients in UC clinical studies with prenatal (maternal/paternal) exposure to tofacitinib. Methods Pregnancies with maternal/paternal exposure to tofacitinib were identified and outcomes reported in 5 tofacitinib UC interventional studies (up to March 2017). Outcomes from tofacitinib rheumatoid arthritis (RA), psoriasis, and psoriatic arthritis interventional studies, and RA noninterventional postapproval safety studies, spontaneous adverse event reporting, and registry data are also reported. Results Of 1157 patients enrolled in the UC interventional studies, 301 were women of childbearing age. Eleven cases of maternal exposure and 14 cases of paternal exposure to tofacitinib (doses of 5 mg or 10 mg twice daily) before/at the time of conception or during pregnancy were identified. Outcomes included 15 healthy newborns, no fetal deaths, no neonatal deaths, no congenital malformations, 2 spontaneous abortions, and 2 medical terminations. Outcomes across other tofacitinib studies and postmarketing cases were consistent, with a healthy newborn being the most common outcome and no fetal deaths. Conclusions Based on the limited data available, pregnancy and newborn outcomes among patients with prenatal (maternal/paternal) exposure to tofacitinib in UC studies appear similar to those reported for other tofacitinib clinical study populations and the general population.

• Publisher: Oxford University Press
• Subject: Abortion / Adult / Arthritis / Birth defects / Clinical trials / Colitis / Colitis, Ulcerative - drug therapy / Complications and side effects / Databases, Factual / Dosage and administration / Drug therapy / Female / Gastrointestinal diseases / Genetic disorders / Humans / IBD Live / Infant mortality / Infant, Newborn / Inflammatory bowel disease / Inflammatory bowel diseases / Janus Kinase Inhibitors - administration & dosage / Male / Maternal Exposure / Medical research / Newborn infants / Paternal Exposure / Piperidines - administration & dosage / Pregnancy / Pregnancy Outcome / Pregnant women / Prenatal drug exposure / Psoriasis / Psoriatic arthritis / Pyrimidines - administration & dosage / Pyrroles - administration & dosage / Randomized Controlled Trials as Topic / Rheumatoid factor / Risk factors / Tofacitinib / Ulcerative colitis / Young Adult