Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial
Objective The objective of this study is to evaluate the efficacy and safety of jaktinib hydrochloride tablets (jaktinib), a Janus kinase inhibitor, in patients with active radiographic axial spondyloarthritis (r-axSpA).Methods Adults with active r-axSpA who met modified New York criteria and had an...
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BMJ Publishing Group
2025-01-01
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| author | Xiaomei Li Xiaoxia Wang Jian Wu Xiao Zhang Chunde Bao Shengqian Xu Lingyun Sun Juan Wang Guixiu Shi Xiaofei Wang Qing Dai Antao Xu Huaxiang Wu YongQing Wang Yan Ye Yongfu Wang Huaxiang Liu Chenyin Lv Jun Miao Weiqi Min Kuanting Wang Luan Xue Shanhui Ye |
| author_facet | Xiaomei Li Xiaoxia Wang Jian Wu Xiao Zhang Chunde Bao Shengqian Xu Lingyun Sun Juan Wang Guixiu Shi Xiaofei Wang Qing Dai Antao Xu Huaxiang Wu YongQing Wang Yan Ye Yongfu Wang Huaxiang Liu Chenyin Lv Jun Miao Weiqi Min Kuanting Wang Luan Xue Shanhui Ye |
| author_sort | Xiaomei Li |
| collection | DOAJ |
| description | Objective The objective of this study is to evaluate the efficacy and safety of jaktinib hydrochloride tablets (jaktinib), a Janus kinase inhibitor, in patients with active radiographic axial spondyloarthritis (r-axSpA).Methods Adults with active r-axSpA who met modified New York criteria and had an inadequate response to non-steroidal anti-inflammatory drugs were randomised 1:1:1 to receive jaktinib 75 mg two times per day, 100 mg two times per day, or placebo. The primary and key secondary endpoints were Assessment of SpondyloArthritis international Society 20 (ASAS 20) and ASAS 40 responses, respectively, at week 16. Safety was evaluated by analysing adverse events.Results A total of 107 patients with active r-axSpA were randomised (jaktinib 75 mg two times per day, n=35; jaktinib 100 mg two times per day, n=36; placebo, n=36). In the ASAS20 response rates, the 100 mg two times per day group had the highest response at 61.1%, followed by the 75 mg two times per day group at 57.1%, and the placebo group had the lowest at 33.3% for the 16 weeks of treatment. The ASAS40 response rates were significantly higher with jaktinib (100 mg two times per day group: 47.2%, 75 mg two times per day group: 37.1%) compared with placebo (13.9%). The incidence of treatment-emergent adverse events in the 75 mg two times per day, 100 mg two times per day and placebo groups was 88.6% versus 94.4% versus 86.1%, respectively, with no statistically significant difference among the three groups. No major adverse cardiovascular events, malignancy, thromboembolism or deaths were reported.Conclusions Jaktinib showed good efficacy and tolerability in the treatment of active r-axSpA, with the 100 mg two times per day showing a trend towards better efficacy.Trial registration number NCT04507659. |
| format | Article |
| id | doaj-art-2fa2cea6d6374d20ba9893e298a0dbc7 |
| institution | Kabale University |
| issn | 2056-5933 |
| language | English |
| publishDate | 2025-01-01 |
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| spelling | doaj-art-2fa2cea6d6374d20ba9893e298a0dbc72025-01-20T10:05:10ZengBMJ Publishing GroupRMD Open2056-59332025-01-0111110.1136/rmdopen-2024-004865Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trialXiaomei Li0Xiaoxia Wang1Jian Wu2Xiao Zhang3Chunde Bao4Shengqian Xu5Lingyun Sun6Juan Wang7Guixiu Shi8Xiaofei Wang9Qing Dai10Antao Xu11Huaxiang Wu12YongQing Wang13Yan Ye14Yongfu Wang15Huaxiang Liu16Chenyin Lv17Jun Miao18Weiqi Min19Kuanting Wang20Luan Xue21Shanhui Ye22Department of Rheumatology, The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Hefei, China21 Department of Rheumatology and Immunology, Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, ChinaDepartment of Cardiology, the Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China1 Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xian, ChinaDepartment of Rheumatology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaRheumatology and Immunology Department, The First Affiliated Hospital of Anhui Medical University, Hefei, ChinaDepartment of Rheumatology and Immunology, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, ChinaDepartment of Rheumatology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China2the First Affiliated Hospital of Xiamen University, Xiamen, ChinaBeijing Advanced Innovation Center for Biomedical Engineering, Key Laboratory for Biomechanics and Mechanobiology of Ministry of Education, School of Biological Science and Medical Engineering, Beihang University, Beijing, ChinaDepartment of Rheumatology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Rheumatology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Rheumatology, The Second Affiliated hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, ChinaDepartment of Liver Disease, No.88 Hospital of the Chinese People’s Liberation Army, Tai’an, Shandong, ChinaDepartment of Rheumatology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Rheumatology and Immunology, Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, ChinaRheumatology Department, Qilu Hospital of Shandong University, Jinan, ChinaDepartment of Rheumatology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, ChinaDepartment of Spinal Surgery, Tianjin Hospital, Tianjin, ChinaDepartment of Rheumatology and Immunology, Heze Municipal Hospital, Heze, Shandong Province, ChinaDepartment of Rheumatology and Immunology, Peking University Shougang Hospital, Beijing, ChinaDepartment of Rheumatology and Immunology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaDepartment of Rheumatology and Immunology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, ChinaObjective The objective of this study is to evaluate the efficacy and safety of jaktinib hydrochloride tablets (jaktinib), a Janus kinase inhibitor, in patients with active radiographic axial spondyloarthritis (r-axSpA).Methods Adults with active r-axSpA who met modified New York criteria and had an inadequate response to non-steroidal anti-inflammatory drugs were randomised 1:1:1 to receive jaktinib 75 mg two times per day, 100 mg two times per day, or placebo. The primary and key secondary endpoints were Assessment of SpondyloArthritis international Society 20 (ASAS 20) and ASAS 40 responses, respectively, at week 16. Safety was evaluated by analysing adverse events.Results A total of 107 patients with active r-axSpA were randomised (jaktinib 75 mg two times per day, n=35; jaktinib 100 mg two times per day, n=36; placebo, n=36). In the ASAS20 response rates, the 100 mg two times per day group had the highest response at 61.1%, followed by the 75 mg two times per day group at 57.1%, and the placebo group had the lowest at 33.3% for the 16 weeks of treatment. The ASAS40 response rates were significantly higher with jaktinib (100 mg two times per day group: 47.2%, 75 mg two times per day group: 37.1%) compared with placebo (13.9%). The incidence of treatment-emergent adverse events in the 75 mg two times per day, 100 mg two times per day and placebo groups was 88.6% versus 94.4% versus 86.1%, respectively, with no statistically significant difference among the three groups. No major adverse cardiovascular events, malignancy, thromboembolism or deaths were reported.Conclusions Jaktinib showed good efficacy and tolerability in the treatment of active r-axSpA, with the 100 mg two times per day showing a trend towards better efficacy.Trial registration number NCT04507659.https://rmdopen.bmj.com/content/11/1/e004865.full |
| spellingShingle | Xiaomei Li Xiaoxia Wang Jian Wu Xiao Zhang Chunde Bao Shengqian Xu Lingyun Sun Juan Wang Guixiu Shi Xiaofei Wang Qing Dai Antao Xu Huaxiang Wu YongQing Wang Yan Ye Yongfu Wang Huaxiang Liu Chenyin Lv Jun Miao Weiqi Min Kuanting Wang Luan Xue Shanhui Ye Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial RMD Open |
| title | Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial |
| title_full | Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial |
| title_fullStr | Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial |
| title_full_unstemmed | Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial |
| title_short | Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial |
| title_sort | efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis a multicentre randomised double blind placebo controlled phase ii clinical trial |
| url | https://rmdopen.bmj.com/content/11/1/e004865.full |
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