Efficacy and Safety of Ivarmacitinib, a Selective JAK1 Inhibitor, in Patients with Active Ankylosing Spondylitis: Results from an Adaptive Seamless Phase II/III Trial
机构：[1]Department of Rheumatology & Immunology, Peking University People's Hospital, Beijing, China[2]Department of Rheumatology & Immunology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China[3]Department of Rheumatology & Immunology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China[4]Department of Rheumatology & Immunology, Nanjing Drum Tower Hospital, Nanjing, China[5]Department of Rheumatology & Immunology, Zhengzhou Central Hospital, Zhengzhou, China[6]Department of Rheumatology & Immunology, Zhongda Hospital Southeast University, Nanjing, China[7]Department of Rheumatology & Immunology, The First Hospital Affiliated with Nanchang University, Nanchang, China[8]Department of Rheumatology & Immunology, First Hospital of Shanxi Medical University, Taiyuan, China[9]Department of Rheumatology & Immunology, Sichuan Provincial People's Hospital, Chengdu, China四川省人民医院[10]Department of Rheumatology & Immunology, The First Affiliated Hospital of Anhui Medical University, Hefei, China[11]Department of Clinical Immunology, The First Affiliated Hospital of the Fourth Military Medical University, Xi'an, China[12]Department of Rheumatology & Immunology, The Third Hospital of Hebei Medical University,Shijiazhuang, China[13]Department of Rheumatology & Immunology, The Second Hospital of Shanxi Medical University, Taiyuan, China[14]Department of Rheumatology & Immunology, The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China深圳市中医院深圳医学信息中心[15]Department of Rheumatology & Immunology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China浙江大学医学院附属第一医院[16]Department of Rheumatology & Immunology, Hainan Provincial People's Hospital, Haikou, China[17]Department of Rheumatology & Immunology, North Jiangsu People's Hospital, Yangzhou, China江苏省人民医院[18]Department of Rheumatology & Immunology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China广东省中医院[19]Internal Medicine - Immunology, QiLu Hospital of Shandong University, Jinan, China[20]Department of Rheumatology & Immunology, Zaozhuang Municipal Hospital, Zaozhuang, China[21]Department of Rheumatology & Immunology, The First Affiliated Hospital of Xiamen University, Xiamen, China[22]Department of Rheumatology & Immunology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China北京朝阳医院[23]Department of Rheumatology & Immunology, Xinxiang Central Hospital, Xinxiang, China[24]Department of Rheumatology & Immunology, The First Hospital of Jilin University, Changchun, China[25]Department of Rheumatology & Immunology, ShengJing Hospital of China Medical University, Shenyang, China中国医科大学附属盛京医院中国医科大学盛京医院[26]Department of Rheumatology & Immunology, Liuzhou Workers Hospital, Liuzhou, China[27]Department of Traditional Chinese Medicine and Rheumatology, First Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China[28]Department of Rheumatology, Immunology and Allergology, Xuanwu Hospital, Capital Medical University, Beijing, China首都医科大学宣武医院[29]Rheumatism Department, Shanghai Yueyang Integrated Traditional Chinese and Western Medicine Hospital, Shanghai, China[30]Department of Rheumatology & Immunology, Xiling Campus of Yichang Central People's Hospital, Yichang, China[31]Department of Rheumatology & Immunology, The First Affiliated Hospital and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, China[32]Department of Rheumatology & Immunology, The First Affiliated Hospital of Harbin Medical University, Harbin, China[33]Clinical Research and Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
This randomized, double-blind, adaptive phase II/III trial aimed to evaluate the efficacy and safety of ivarmacitinib, a novel selective JAK1 inhibitor, in patients with active ankylosing spondylitis (AS).In phase II, patients were randomized (1:1:1:1) to receive ivarmacitinib at doses of 2 mg, 4 mg, or 8 mg, or placebo once daily for 12 weeks. Based on interim analysis, ivarmacitinib 4 mg was selected as the recommended dose. In phase III, patients were randomized (1:1) to receive ivarmacitinib 4 mg or placebo for 12 weeks; from week 12 onward, all patients received ivarmacitinib 4 mg once daily through week 24. The primary endpoint was the proportion of patients achieving a ≥20% improvement in the Assessment of Spondyloarthritis International Society (ASAS20) response criteria at week 12.During the entire study, 504 patients were randomized (ivarmacitinib 4 mg, n=187; placebo, n=186). At week 12, the ASAS20 response rate was significantly higher in the ivarmacitinib 4 mg group compared to placebo (48.7% vs. 29.0%; one-sided P = 0.0001). The ASAS40 response rate (32.1% vs. 18.3%) and all other secondary endpoints also favored ivarmacitinib 4 mg. Efficacy was sustained through 24 weeks. During the placebo-controlled period, treatment-emergent adverse events occurred in 79.7% of the ivarmacitinib group and 65.6% of the placebo group.Ivarmacitinib 4 mg significantly improved the signs and symptoms of AS at week 12 compared to placebo, with sustained efficacy through 24 weeks and a tolerable safety profile. These findings support ivarmacitinib 4 mg as a new treatment option for active AS.This article is protected by copyright. All rights reserved.
基金：
We are grateful to all participants and their families and all members of the study group. Medical
writing support was provided by Lin Dong, PhD (a medical writer at Jiangsu Hengrui
Pharmaceuticals Co, Ltd) according to Good Publication Practice Guidelines.
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外文
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第一作者：
第一作者机构：[1]Department of Rheumatology & Immunology, Peking University People's Hospital, Beijing, China
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推荐引用方式(GB/T 7714)：
Liu Xu,Xu Liling,Zhao Cheng,et al.Efficacy and Safety of Ivarmacitinib, a Selective JAK1 Inhibitor, in Patients with Active Ankylosing Spondylitis: Results from an Adaptive Seamless Phase II/III Trial[J].Arthritis & Rheumatology (Hoboken, N.J.).2025,doi:10.1002/art.43238.
APA：
Liu Xu,Xu Liling,Zhao Cheng,Liu Shengyun,Sun Lingyun...&Li Zhanguo.(2025).Efficacy and Safety of Ivarmacitinib, a Selective JAK1 Inhibitor, in Patients with Active Ankylosing Spondylitis: Results from an Adaptive Seamless Phase II/III Trial.Arthritis & Rheumatology (Hoboken, N.J.),,
MLA：
Liu Xu,et al."Efficacy and Safety of Ivarmacitinib, a Selective JAK1 Inhibitor, in Patients with Active Ankylosing Spondylitis: Results from an Adaptive Seamless Phase II/III Trial".Arthritis & Rheumatology (Hoboken, N.J.) .(2025)
医学