P546 Comparative efficacy and safety of upadacitinib versus ustekinumab as induction therapy in patients with moderately to severely active ulcerative colitis: A matching-adjusted indirect comparison
Abstract
Upadacitinib (UPA), an oral Janus kinase inhibitor, and ustekinumab (UST), a parenteral IL-12/23 inhibitor, are approved therapies for patients (pts) with moderately to severely active Ulcerative Colitis (UC). In the absence of head-to-head data, we conducted a placebo (PBO)-anchored matching-adjusted indirect comparison (MAIC) to compare efficacy and safety of UPA vs UST during induction.
Pts received UPA 45 mg oral, once daily for 8 weeks or PBO in the phase 3 studies U-ACHIEVE (NCT02819635) and U-ACCOMPLISH (NCT03653026), and UST 6 mg/kg IV at week 0 with 8-week follow up or PBO in the phase 3 study UNIFI (NCT02407236). Efficacy outcomes were stratified by previous biologic exposure (ie, no prior exposure [bio-naïve] or inadequate response, loss of response, or intolerance to biologics [bio-failed]). Baseline characteristics for age, gender, extent and duration of disease, total Inflammatory Bowel Disease Questionnaire score, total Mayo score, high-sensitivity CRP, faecal calprotectin levels, weight, and UC medication use from the UPA trials were weighted to match the UNIFI trial. Efficacy outcomes at Week 8 were clinical remission per full Mayo score (FMS; FMS ≤2 with no subscore >1), clinical response (decrease in FMS ≥3 points and ≥30%, plus a decrease in rectal bleeding score [RBS] of ≥1 or an absolute RBS of 0 or 1), endoscopic improvement (endoscopic subscore 0 or 1), and histologic-endoscopic mucosal improvement (HEMI). Safety outcomes evaluated in the overall…
Read the paper
Related studies
- Meta-analysis and the science of research synthesis
- Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial
- Cluster Randomized Controlled Trial
- Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial
- Disease Free Survival and Local Recurrence for Laparoscopic Resection Compared to Open Resection of Stage II-III Rectal Cancer: Follow up Results of the ACOSOG Z6051 Randomized Controlled Trial
- The effects of a course of intranasal oxytocin on social behaviors in youth diagnosed with autism spectrum disorders: a randomized controlled trial
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.