Abstract Background Ulcerative colitis (UC) is a chronic, inflammatory condition of the rectum and colon of unknown aetiology. Risankizumab (RZB), an anti-interleukin 23p19 monoclonal antibody, demonstrated efficacy for moderately to severely active UC in the 12-week phase 2b/3 INSPIRE induction study. The aim of these analyses was to investigate the efficacy and safety of RZB in induction treatment for Chinese patients with moderate and severe UC. Methods These post hoc analyses for Chinese patients of pooled data from the 12-week phase 2b/3 INSPIRE induction study. Eligible patients (18-80 years) with moderately to severely active UC and an endoscopic sub score of 2-3 were enrolled. For the induction trial, patients were randomized 2:1 to receive 1200 mg of RZB or placebo administered intravenously at weeks 0, 4, and 8. The primary endpoint was clinical remission per Adapted Mayo Score (AMS) at week 12. Key ranked secondary endpoints included clinical response rates, endoscopic improvement, histological-endoscopic mucosal improvement, endoscopic remission, achievement of no nocturnal bowel movements, achievement of no tenesmus at week 12. Adverse events (AEs) assessment included patients received at least one dose of study drug. Results The 88 participants had a mean age of 43.0 years, mean disease duration of 4.6 years, mean AMS 6.8 and prior advanced therapies 21.6%. At week 12, the clinical remission rate (per AMS) was higher in RZB 1200 mg IV arm than the rate in placebo arm (26.3% vs. 6.5%, treatment difference 19.9% 5.5, 34.2, p 0.05). For ranked secondary endpoints, higher clinical response rates (per AMS at week 12: 71.9% vs. 38.7%, treatment difference 33.2% 12.5, 54.0 ,p0.01); achievement of endoscopic improvement at week 12: 42.1% vs. 9.7%, treatment difference 32.4%15.9, 48.9, p0.01), achievement of histological-endoscopic mucosal improvement at week 12 (26.3% vs. 3.2%, treatment difference 23.1% 10.1, 36.1 p 0.01)), were met for RZB vs. PBO, respectively. The endoscopic remission rate at week 12 was numerically higher in the RZB group compared to PBO (10.5% vs. 0%, treatment difference 10.5% 2.6, 18.5, p = 0.0862). Adverse event (AE) rates in RZB and PBO were 49.1% vs 51.6% for overall AEs; 3.5% vs 16.1% for serious AEs;7.0% vs 12.9% for severe AEs; 0% vs 3.2% for AEs leading to discontinuation of study drug, all numerically lower in the RZB arm. No deaths or safety concerns were observed for RZB 1200 mg IV arm. Conclusion In participants from China with moderately to severely active ulcerative colitis, RZB demonstrated greater clinical remission and secondary clinical, endoscopic, and endoscopic histologic endpoints compared to PBO. RZB was well-tolerated, and no new safety risks were observed. Reference: Louis E, et al. JAMA. 2024;332(11):881-897. Conflict of interest: Wu, Kaichun: No conflict of interest Cao, Qian: No conflict of interest An, Ping: No conflict of interest Ran, Zhihua: No conflict of interest Wang, Xin: No conflict of interest Zhang, Xiaolan: No conflict of interest Zhan, Qiang: No conflict of interest Zhang, Hu: No conflict of interest Gao, Xiang: No conflict of interest Yang, Shaoqi: No conflict of interest Hu, Naizhong: No conflict of interest Chen, Yan: No conflict of interest Zhong, Jie: No conflict of interest. Tang, Tongyu: No conflict of interest Zhang, Guoxin: No conflict of interest Zhang, Jie: No conflict of interest Chen, Youxiang: No conflict of interest Hou, Xiaohua: No conflict of interest Tian, De’an: No conflict of interest Liu, Fei: No conflict of interest Zou, Xiaoping: No conflict of interest Lu, Lungen: No conflict of interest Li, Yan: No conflict of interest Zhang, Yafei: An employee of AbbVie Kalabic, Jasmina: An employee of AbbVie Duan, W. Rachel: An employee of AbbVie
Wu et al. (Thu,) studied this question.