Efficacy and Safety of Risankizumab Among Patients With Ulcerative Colitis in East Asia: A Post Hoc Analysis of Two Randomized Clinical Trials
In brief
Risankizumab brought 22% of East Asian patients with ulcerative colitis into remission
In this post hoc analysis of phase 3 trials, 21.7% of East Asian patients receiving risankizumab were in clinical remission after 12 weeks, compared with 5.8% on placebo. At 52 weeks, remission rates were 36.9% and 58.0% with two maintenance doses, versus 26.7% after treatment withdrawal; adverse event rates were similar. These regional findings support benefit, but the analysis was not designed specifically to compare East Asian patients.
- Journal
- Journal of gastroenterology and hepatology (Q1)
- Published
- 21 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Ken Takeuchi, Qian Cao, Keiji Ozeki, Sang-Bum Kang, Jen-Wei Chou, Madhuja Mallick, et al.
- PMID
- 42908036
- DOI
- 10.1111/jgh.70800
Why clinicians should know about it
- Picked for Gastroenterology (paper of the day, 23 October 2026): Post hoc analysis, risankizumab effective in ulcerative colitis
Abstract
BACKGROUND AND AIM: Risankizumab, a monoclonal interleukin 23p19 antibody, is a treatment for ulcerative colitis. This post hoc analysis reports the efficacy and safety of risankizumab for ulcerative colitis in patients in East Asia from the global phase 3 clinical trials. METHODS: In the 12-week, phase 2b/3 induction study (NCT03398148), adults with moderately to severely active ulcerative colitis were randomized 2:1 to intravenous risankizumab 1200 mg or placebo at Weeks 0, 4, and 8. Patients with clinical response to 12 weeks of intravenous risankizumab induction therapy were randomized 1:1:1 to subcutaneous risankizumab 180 mg, risankizumab 360 mg, or placebo (risankizumab withdrawal) every 8 weeks in the 52-week phase 3 maintenance study (NCT03398135). This post hoc analysis evaluated data from patients in China, Japan, South Korea, and Taiwan. RESULTS: Data from 256 and 130 East Asian patients in the induction and maintenance studies, respectively, were analyzed. Clinical remission per Adapted Mayo score was achieved at higher rates with risankizumab vs. placebo at induction Week 12 (risankizumab 1200 mg, 21.7%; placebo, 5.8%) and maintenance Week 52 (risankizumab 180 mg, 36.9%; risankizumab 360 mg, 58.0%; placebo [withdrawal], 26.7%). Clinical, endoscopic, and histologic outcomes were achieved at higher rates with risankizumab vs. placebo induction and maintenance therapy. Treatment-emergent adverse event rates were similar between treatment groups in induction and maintenance studies with no new safety signals identified. CONCLUSION: Risankizumab improved disease outcomes among patients with moderately to severely active ulcerative colitis in East Asian countries, with a safety profile consistent with the global study.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.