Background and aims: This post hoc analysis assessed the efficacy and safety of upadacitinib in patients with moderately to severely active ulcerative colitis stratified by corticosteroid use from the ulcerative colitis Phase 3 clinical trial programme.
Methods: Patients were randomised [1:2] to 8 weeks' placebo or upadacitinib 45 mg once daily [QD]; Week 8 responders were re-randomised [1:1:1] to 52 weeks' placebo, or upadacitinib 15 or 30 mg QD. Corticosteroid dose was kept stable during induction but tapered according to a protocol-defined schedule [or investigator discretion] during maintenance Weeks 0-8. Efficacy outcomes and exposure-adjusted treatment-emergent adverse event [TEAE] rates were assessed for induction and maintenance stratified by corticosteroid use at induction baseline.
Results: Overall, 377/988 [38%] patients were receiving corticosteroids at induction baseline [placebo, n = 133; upadacitinib 45 mg, n = 244] and 252 [37%] of the 681 clinical responders who entered maintenance were on corticosteroids at induction baseline [n = 84 for each treatment]. Similar proportions of patients receiving upadacitinib achieved clinical remission per Adapted Mayo Score with/without corticosteroids at Weeks 8 and 52. The total proportion of patients re-initiating corticosteroids was higher with placebo [24/84 (29%)] vs UPA 15 mg [16/81 (20%)] and 30 mg [11/81 (14%)]. During induction, patients receiving corticosteroids at baseline had higher rates of TEAEs, serious TEAEs, and serious infections vs those not receiving corticosteroids; however, TEAE rates were similar during maintenance after corticosteroid withdrawal.
Conclusions: Upadacitinib is an effective steroid-sparing treatment in patients with moderately to severely active ulcerative colitis.
Keywords: Clinical trials.
© The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.