2. Academic Validation
  3. Xeligekimab, an Interleukin-17A Antagonist for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 48-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study

Xeligekimab, an Interleukin-17A Antagonist for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 48-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study

  • BioDrugs. 2026 Jan;40(1):151-162. doi: 10.1007/s40259-025-00750-0.
Shangzhu Zhang 1 2 3 4,  Dong Xu 1 2 3 4,  Shengyun Liu 5,  Shujie Li 6,  Xiaoxia Wang 7,  Fenghong Yuan 8,  Wei Gou 9,  Baijie Xu 10,  Lingyun Sun 11,  Jieruo Gu 12,  Dongmei Zhou 13,  Xiaomei Li 14,  Ning Kong 15,  Yi Zhao 16,  Jie Hao 17,  Tianwang Li 18,  Xiaoyun Fan 19,  Qiang Shu 20,  Hua Wei 21,  Tao Jiang 22,  Jing Yang 23,  Long Qian 24,  Hongsheng Sun 25,  Xiaoyan Cai 26,  Zhenyu Jiang 27,  Guohua Yuan 28,  Li Qin 29,  Min Yang 30,  Jian Xu 31,  Wenqiang Fan 32,  Li Sun 33,  Hua Zhang 34,  Chunyan Zhang 35,  Ning Zhang 36,  Zhanyun Da 37,  Jiankang Hu 38,  Jingchun Jin 39,  Ju Liu 40,  Lie Dai 41,  Lingli Dong 42,  Wei Wang 43,  Xiaofeng Zeng 44 45 46 47
Affiliations

Affiliations

  • 1 Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
  • 2 National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Ministry of Science and Technology, Beijing, China.
  • 3 State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Beijing, China.
  • 4 Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China.
  • 5 Department of Rheumatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
  • 6 Department of Rheumatology, Jining No. 1 People's Hospital, Jining, China.
  • 7 Department of Rheumatology, Second Hospital of Shanxi Medical University, Taiyuan, China.
  • 8 Rheumatism immunity branch, Wuxi People's Hospital, Wuxi, China.
  • 9 Department of Rheumatology, Hebei PetroChina Central Hospital, Langfang, China.
  • 10 Rheumatology and Immunology Department, Jieyang People's Hospital, Jieyang, China.
  • 11 Rheumatology and Immunology Department, Nanjing Drum Tower Hospital, Nanjing, China.
  • 12 Rheumatology and Immunology Department, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
  • 13 Department of Rheumatology and Immunology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
  • 14 Rheumatology and Immunology Department, Anhui Provincial Hospital, Hefei, China.
  • 15 Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai, China.
  • 16 Rheumatic Immunology Department, West China Hospital of Sichuan University, Chengdu, China.
  • 17 Department of Rheumatology, CANGZHOU People's Hospital, Cangzhou, China.
  • 18 Rheumatism Immunity Branch, Guangdong Second Provincial General Hospital, Guangzhou, China.
  • 19 Department of Rheumatology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
  • 20 Department of Rheumatology, Qilu Hospital of Shandong University, Jinan, China.
  • 21 Rheumatology and Immunology Department, North Jiangsu People's Hospital, Yangzhou, China.
  • 22 Department of Division of Rheumatology, Jilin Province People's Hospital, Changchun, China.
  • 23 Rheumatic Immunology Department, Mianyang Central Hospital, Mianyang, China.
  • 24 Rheumatology and Immunology Department, The Second Affiliated Hospital of Anhui Medical University, Hefei, China.
  • 25 Rheumatology and Immunology Department, Shandong First Medical University Affiliated Provincial Hospital, Jinan, China.
  • 26 Department of Rheumatology, Guangzhou First People's Hospital, Guangzhou, China.
  • 27 Rheumatology and Immunology Department, First Hospital of Jilin University, Changchun, China.
  • 28 Rheumatic Immunology Department, Affiliated Hospital of North Sichuan Medical College, Nanchong, China.
  • 29 Rheumatism Immunity Branch, Huzhou Third Municipal Hospital, Huzhou, China.
  • 30 Rheumatology Department, Nanfang Hospital of Southern Medical University, Guangzhou, China.
  • 31 Department of Rheumatology and Immunology, First Affiliated Hospital of Kunming Medical University, Kunming, China.
  • 32 Department of Rheumatology and Immunology, Xinxiang Central Hospital, Xinxiang, China.
  • 33 Rheumatology and Immunology Department, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
  • 34 Department of Rheumatology, Zaozhuang Municipal Hospital (Affiliated Hospital of Jining Medical College), Zaozhuang, China.
  • 35 Rheumatology Department, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
  • 36 Department of Rheumatology and Immunology, Shengjing Hospital of China Medical University, Shenyang, China.
  • 37 Rheumatism Immunity Branch, Affiliated Hospital of Nantong University, Nantong, China.
  • 38 Department of Rheumatology and Immunology, Pingxiang People's Hospital, Pingxiang, China.
  • 39 Rheumatology and Immunology Department, Yanbian University Hospital (Yanbian Hospital), Yanbian, China.
  • 40 Rheumatology and Immunology Department, Jiujiang First People's Hospital, Jiujiang, China.
  • 41 Rheumatism Immunity Branch, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
  • 42 Department of Rheumatology and Immunology, Tongji Medical College of HUST, Wuhan, China.
  • 43 Chongqing Genrix Biopharmaceutical Co., Ltd, Chongqing, China.
  • 44 Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China. [email protected].
  • 45 National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Ministry of Science and Technology, Beijing, China. [email protected].
  • 46 State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Beijing, China. [email protected].
  • 47 Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China. [email protected].
PMID: 41247398 DOI: 10.1007/s40259-025-00750-0
Abstract

Background: Xeligekimab is a novel immunoglobulin G4 (IgG4) monoclonal antibody targeting interleukin-17A (IL-17A). In a phase III trial in patients with plaque psoriasis, xeligekimab showed efficacy and safety consistent with other IL-17A inhibitors, supporting its potential application in the treatment of spondyloarthritis.

Objective: This phase III trial aimed to investigate the efficacy and safety of xeligekimab in patients with radiographic axial spondyloarthritis (r-axSpA).

Methods: This was a phase III study conducted at multiple centers in China. Eligible patients were randomly assigned (1:1:1) to receive xeligekimab 100 mg, xeligekimab 200 mg, or placebo. Randomization was stratified by medication history (biologic-experienced vs. biologic-naïve) and weight (≥ 70 kg vs. < 70 kg). The primary endpoint was the proportion of patients achieving an Assessment of SpondyloArthritis International Society 20 (ASAS20) response at week 16. A key secondary endpoint was the ASAS40 response rate at the same time point.

Results: A total of 465 patients were recruited. A significantly higher proportion of patients receiving xeligekimab 200 mg (n = 114 (74.0%); p < 0.001, 95% confidence interval (CI) 28.5-48.4) and xeligekimab 100 mg (n = 102 (65.8%); p < 0.001, 95% CI 19.4-41.0) achieved an ASAS20 response compared to the placebo group (n = 56 (35.9%)) at week 16. Similarly, a significantly higher ASAS40 response rate was observed in the xeligekimab 100 mg group (n = 62 (40.0%); p < 0.001) and the xeligekimab 200 mg group (n = 64 (41.6%); p < 0.001) compared to placebo. Adverse events were similar across all groups, with serious adverse events occurring in 1.6% of the treatment group during the core treatment period. No unexpected safety signals were reported through week 48.

Conclusion: Xeligekimab demonstrated significant efficacy in improving the signs and symptoms of active r-axSpA in Chinese patients at week 16, with sustained effects observed through week 48 and no new safety signals identified.

Trial registration: ClinicalTrials.gov identifier: NCT05881785 (Date: 21 May 2023).

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