Long-term Safety of Upadacitinib in Patients with Inflammatory Bowel Disease: Integrated Analysis of Phase 2/3 Studies - PubMed
5 hours ago
- #Upadacitinib
- #JAK inhibitor
- #Inflammatory Bowel Disease
- Upadacitinib (UPA) is an oral Janus kinase inhibitor approved for treating ulcerative colitis (UC) and Crohn's disease (CD).
- The study assessed long-term safety of UPA in inflammatory bowel disease (IBD) through integrated analysis of 6 UC/CD trials.
- Patients received UPA 45 mg induction, UPA 15/30 mg maintenance, or placebo, with cumulative exposure of 5149.3 patient-years.
- Adverse event (AE) incidence was comparable between UPA and placebo, with lower rates of severe AEs and discontinuations in UPA groups.
- Rates of serious AEs like venous thromboembolic events, gastrointestinal perforations, and deaths were low across UPA doses.
- Herpes zoster, neutropenia, lymphopenia, and COVID-19 were more common in UPA groups compared to placebo.
- UPA demonstrated a favorable long-term safety profile, supporting its use in IBD treatment.