Efficacy and Safety of Risankizumab Among Patients With Ulcerative Colitis in East Asia: A Post Hoc Analysis of Two Randomized Clinical Trials
Ken Takeuchi, Qian Cao, Keiji Ozeki, Sang‐Bum Kang, Jen‐Wei Chou, Madhuja Mallick, Tomoko Matsuda, Pierre A. Morisset, Jasmina Kalabic, Ronilda D'Cunha, Yuji Ogawa, Yafei Zhang, W. Rachel Duan, Yuh‐Ying Yeh, Tadakazu HisamatsuABSTRACT
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.