Mahadevan, Uma

INTRODUCTION: Long-term data are needed for offspring exposed in utero to medications for inflammatory bowel disease (IBD). METHODS: We used a prospective cohort of pregnant women with IBD and their offspring (Pregnancy in IBD and Neonatal Outcomes) to compare rates of serious infection, congenital malformations, and developmental delay by medication exposures. RESULTS: We included 438 offspring with at least 4 years of follow-up. No differences in adverse outcomes were observed by medication. Preterm birth, but not specific drug exposure, was associated with infection risk. Breastfeeding was not associated with serious infection differences. DISCUSSION: These findings support the use of effective IBD therapies throughout pregnancy.

Abstract Background Upadacitinib is a selective Janus kinase inhibitor approved for the management of ulcerative colitis and is under evaluation for the management of Crohn’s disease [CD] in Phase 3 clinical trials. Aims Our goal was to describe our real-world experience with upadacitinib in CD. Methods This is a two-centre retrospective cohort study of adult patients with moderate to severe CD on upadacitinib. The primary outcome was clinical response and remission as determined by stool frequency and abdominal pain scores. Secondary endpoints included endoscopic response and remission as determined by change in Simple Endoscopic Score for CD. Outcomes were assessed at 3 months after starting upadacitinib and at the patient’s most recent follow-up. We further evaluated adverse events and dose-related response. Results A total of 45 CD patients received upadacitinib and were included in the safety analysis. Thirty-six patients received upadacitinib for CD, whereas nine received it for inflammatory arthritis [n = 8] or pyoderma [n = 1]. Thirty-three patients received upadacitinib for 3 months or longer and were included in the efficacy analysis. At the 3-month follow-up, 21 patients achieved clinical response [63.6%] and nine achieved clinical remission [27.2%]. At time of last follow-up, 23 patients had clinical response [69.7%], ten achieved clinical remission [30.3%] and four [28.6%] achieved endoscopic remission. Adverse events occurred in 12 patients [26.7%]. Two patients had a serious adverse event [4.5%] without associated mortality. Conclusion In this real-world cohort of highly refractory CD patients, upadacitinib was effective in inducing remission and had an acceptable safety profile.