Upadacitinib shows promise as maintenance therapy for active ulcerative colitis
Upadacitinib, an oral JAK inhibitor, has shown significant efficacy as a maintenance therapy for patients with moderately to severely active ulcerative colitis, according to a study.
The study demonstrated that both maintenance doses of upadacitinib led to a higher proportion of patients achieving clinical remission compared to placebo.
In this phase 3 U-ACHIEVE Maintenance study, the efficacy and safety of upadacitinib as a maintenance therapy were evaluated in 987 patients. Out of these, 681 patients demonstrated a clinical response and were subsequently included in the U-ACHIEVE Maintenance analysis. The primary endpoint, clinical remission per adapted Mayo score, was achieved by a significantly higher proportion of patients in the upadacitinib groups (15 mg: 40.4%, 30 mg: 53.6%) compared to placebo (10.8%).
Safety was assessed through exposure-adjusted event rates (EAERs) and indicated a favorable safety profile for upadacitinib. Notable adverse events included worsening of ulcerative colitis, COVID-19 pneumonia, and cryptococcal pneumonia. Higher EAERs for certain events of special interest, such as herpes zoster, hepatic disorders, creatine phosphokinase elevation, and neutropenia, were observed with upadacitinib compared to placebo. In addition, adjudicated major adverse cardiovascular events and venous thromboembolic events occurred infrequently and were largely associated with patients who had known relevant risk factors.
Vermeire S, Danese S, Zhou W, et al. Efficacy and safety of upadacitinib maintenance therapy for moderately to severely active ulcerative colitis in patients responding to 8 week induction therapy (U-ACHIEVE Maintenance): overall results from the randomised, placebo-controlled, double-blind, phase 3 maintenance study. Lancet Gastroenterol Hepatol. 2023;S2468-1253(23)00208-X. doi: 10.1016/S2468-1253(23)00208-X. Epub ahead of print. PMID: 37683686.