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
  • 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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