Risankizumab in a Japanese Real‐World Crohn's Disease Cohort: Clinical Effectiveness in Moderate‐to‐Severely Active Disease, Endoscopic Outcomes, and Persistence
Yoshihiro Yokoyama, Hiroki Tanaka, Maki Miyakawa, Masanao Nasuno, Takahiro Ito, Atsuo Maemoto, Takehiko Katsurada, Katsuyoshi Ando, Aki Sakatani, Nobuhiro Ueno, Tomoe Kazama, Daisuke Hirayama, Shigeru Furukawa, Toshihisa Kobayashi, Satoshi Motoya, Tomofumi Ashida, Mikihiro Fujiya, Hiroshi NakaseABSTRACT
Background and Aims
Risankizumab, an interleukin‐23p19 antibody, is effective for Crohn's disease in trials; however, Japanese real‐world data remain limited. We assessed its clinical effectiveness, endoscopic outcomes, treatment persistence, and safety in a multicenter cohort.
Methods
We retrospectively included patients with Crohn's disease treated with risankizumab (September 2022–February 2025) across eight centers. The CDAI‐based effectiveness analysis was restricted to patients with moderate‐to‐severely active disease at baseline (CDAI ≥ 220). Primary endpoints were corticosteroid‐free clinical remission at Weeks 12 and 52. Secondary endpoints included clinical remission and response, endoscopic response and remission, Kaplan–Meier analysis of treatment persistence, adverse events, and subgroup outcomes by prior advanced therapy and ustekinumab exposure. Segment‐based scores compared ileal and colonic outcomes at the first on‐treatment endoscopy in paired cases.
Results
Among 180 patients, 51 had moderate‐to‐severely active disease at baseline and comprised the primary effectiveness population. Among evaluable patients in this population, corticosteroid‐free clinical remission rates were 31% (15/48), 52% (22/42), and 57% (16/28) at Weeks 12, 28, and 52, respectively; clinical remission rates were 40%, 55%, and 61%, respectively. Overall endoscopic response and remission rates were 58% (26/45) and 29% (13/45), respectively. Colonic endoscopic improvement outcomes favored the naïve subgroups (advanced therapy–naïve vs. advanced therapy–exposed: response 100% vs. 60%, p = 0.017; remission 80% vs. 26.7%, p = 0.009; ustekinumab‐naïve vs. ustekinumab‐exposed: response 95.2% vs. 44.4%, p = 0.005; remission 71.4% vs. 11.1%, p = 0.004). Ileal endoscopic improvement showed a similar trend but was not statistically significant. The Week 52 persistence rate was 87%; adverse events occurred in 12% of patients, with no discontinuations related to adverse events.
Conclusions
Risankizumab was associated with corticosteroid‐free clinical remission among patients with moderate‐to‐severely active Crohn's disease included in the primary effectiveness analysis, together with endoscopic improvement in the paired‐endoscopy cohort. Clinical and endoscopic outcomes, as well as treatment persistence, were generally more favorable in advanced therapy‐ and ustekinumab‐naïve patients.