AbstractBackgroundRisankizumab (RZB) is an interleukin 23p19 inhibitor approved for adults with moderately to severely active CD. In phase 3 trials, greater proportions of patients with CD achieved clinical remission and endoscopic response with RZB therapy vs placebo (PBO). This post hoc subanalysis evaluates the efficacy and safety of RZB therapy in Chinese patients from the induction and maintenance studies.MethodsADVANCE and MOTIVATE were randomized, double-blind, PBO-controlled, phase 3 induction studies. Patients with intolerance/inadequate response to biologic and/or conventional therapy were randomized to receive intravenous (IV) RZB (600 or 1200 mg) or PBO at weeks 0, 4, and 8. Clinical responders to IV RZB could enter the phase 3, randomized, double-blind, PBO-controlled maintenance withdrawal study (FORTIFY). Patients were rerandomized to receive subcutaneous (SC) RZB (180 or 360 mg) or PBO (withdrawal) every 8 weeks for 52 weeks. Stool frequency (SF)/abdominal pain score (APS) clinical remission (average daily SF ≤2.8 plus average daily APS ≤1, and both not worse than induction baseline) and endoscopic response (>50% decrease in Simple Endoscopic Score for Crohn’s Disease [SES-CD] from baseline [or ≥2-point reduction from baseline for patients with isolated ileal disease and a baseline SES-CD of 4]) were evaluated.ResultsThis analysis evaluated 75 Chinese patients in the induction studies. Demographic and baseline disease characteristics were generally similar across treatment groups (Table 1).At week 12 of induction, a numerically greater proportion of patients treated with RZB compared with PBO achieved, with percentages of 56.7% and 53.3% for the RZB 600 mg group, 64.7% and 44.1% for the RZB 1200 mg group, and 27.3% and 18.2% for the PBO group, respectively (Figure 1).Among the 50 patients who entered the maintenance study, a numerically greater proportion of patients treated with RZB compared with PBO achieved SF/APS clinical remission and endoscopic response at week 52. with percentages of 73.3% and 66.7% for the RZB 180 mg group, 83.3% and 72.2% for the RZB 360 mg group, and 64.7% and 41.2% for the PBO group, respectively.Similarly, at both week 12 and week 52, patients in the RZB groups achieved numerically greater proportions of Crohn’s Disease Activity Index (CDAI )clinical remission, CDAI clinical response, and endoscopic remission compared to the PBO group.RZB IV and SC doses were well-tolerated in the Chinese patients.ConclusionConsistent with global population results, Chinese patients with moderately to severely active CD treated with RZB achieved clinical and endoscopic outcomes at higher rates than did patients receiving PBO, with a tolerable safety profile.References1. D’Haens G, et al. Lancet. 2022;399:2015–30. 2.Ferrante M, et al. Lancet. 2022;399:2031–46.