Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study
BackgroundEtanercept biosimilar recombinant human TNF-α receptor II: IgG Fc fusion protein (rhTNFR-Fc) has showed its efficacy and safety in Chinese patients with rheumatoid arthritis. However, data on rhTNFR-Fc's application in juvenile idiopathic arthritis (JIA) is limited.MethodsA prospectiv...
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Frontiers Media S.A.
2022-10-01
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| Series: | Frontiers in Pediatrics |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fped.2022.992932/full |
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| author | Xuefeng Xu Xiaohui Liu Wenjie Zheng Jihong Xiao Xiaozhong Li Ling Wu Lixia Zou Qian Ouyang Yaoyao Shangguan Kezhao Lin Xiaomei Dai Yuanling Chen Yiping Xu Jianqiang Wu Meiping Lu |
| author_facet | Xuefeng Xu Xiaohui Liu Wenjie Zheng Jihong Xiao Xiaozhong Li Ling Wu Lixia Zou Qian Ouyang Yaoyao Shangguan Kezhao Lin Xiaomei Dai Yuanling Chen Yiping Xu Jianqiang Wu Meiping Lu |
| author_sort | Xuefeng Xu |
| collection | DOAJ |
| description | BackgroundEtanercept biosimilar recombinant human TNF-α receptor II: IgG Fc fusion protein (rhTNFR-Fc) has showed its efficacy and safety in Chinese patients with rheumatoid arthritis. However, data on rhTNFR-Fc's application in juvenile idiopathic arthritis (JIA) is limited.MethodsA prospective, observational, multicenter study was performed at 6 institutes in China from July 2020 to December 2021. In a 24-week follow-up, patients with JIA including polyarticular JIA and enthesitis related arthritis received rhTNFR-Fc plus methotrexate (MTX) treatment. The primary outcome parameters were improvements of cJADAS-10 (clinical Juvenile Arthritis Disease Activity Score), and the secondary outcome parameter was an inactive disease.Results60 patients completed at least 12-week follow-up, and 57 completed 24-week follow-up. They had high C reactive protein values (11.6 mg/L) and cJADAS-10 (14.6) at baseline. Thirteen patients had morning stiffness. 33 patients showed synovial thickening, and 34 showed bone marrow edemas on MRI. Ultrasonography demonstrated significant joint effusions in 43 patients. The cJADAS-10 sharply decreased from 14.66 at the baseline to 2.4 at 24 weeks of rhTNFR-Fc therapy, respectively (P < 0.01). About half of patients achieved inactive disease at 24 weeks of therapy. Compared with the baseline, the number of patients with morning stiffness, joint effusions, bone marrow edema and synovial thickening on MRI significantly decreased at 24 weeks. Adverse events were consistent with known side effects of biologic agents.ConclusionsThe present study indicated that the combination of rhTNFR-Fc and MTX significantly improve symptoms and disease activity of children with JIA. This study suggests etanercept biosimilar rhTNFR-Fc as an effective and safe therapy for children with JIA. |
| first_indexed | 2024-04-11T10:06:04Z |
| format | Article |
| id | doaj.art-3b06fc655e954e5092ea55b0b8386fe9 |
| institution | Directory Open Access Journal |
| issn | 2296-2360 |
| language | English |
| last_indexed | 2024-04-11T10:06:04Z |
| publishDate | 2022-10-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pediatrics |
| spelling | doaj.art-3b06fc655e954e5092ea55b0b8386fe92022-12-22T04:30:14ZengFrontiers Media S.A.Frontiers in Pediatrics2296-23602022-10-011010.3389/fped.2022.992932992932Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational studyXuefeng Xu0Xiaohui Liu1Wenjie Zheng2Jihong Xiao3Xiaozhong Li4Ling Wu5Lixia Zou6Qian Ouyang7Yaoyao Shangguan8Kezhao Lin9Xiaomei Dai10Yuanling Chen11Yiping Xu12Jianqiang Wu13Meiping Lu14Department of Rheumatology Immunology / Allergy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, ChinaDepartment of Rheumatology and Immunology, Jiangxi Provincial Children's Hospital, Nanchang, ChinaDepartment of Paediatric Rheumatology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, ChinaDepartment of Rheumatology and Immunology, Xiamen University Affiliated First Hospital, Xiamen, ChinaDepartment of Rheumatology and Immunology, Soochow University Children's Hospital, Suzhou, ChinaDepartment of Rheumatology and Immunology, Ningbo Women and Children's Hospital, Ningbo, ChinaDepartment of Rheumatology Immunology / Allergy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, ChinaDepartment of Rheumatology and Immunology, Jiangxi Provincial Children's Hospital, Nanchang, ChinaDepartment of Paediatric Rheumatology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, ChinaDepartment of Rheumatology and Immunology, Xiamen University Affiliated First Hospital, Xiamen, ChinaDepartment of Rheumatology and Immunology, Soochow University Children's Hospital, Suzhou, ChinaDepartment of Rheumatology and Immunology, Ningbo Women and Children's Hospital, Ningbo, ChinaDepartment of Rheumatology Immunology / Allergy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, ChinaDepartment of Rheumatology Immunology / Allergy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, ChinaDepartment of Rheumatology Immunology / Allergy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, ChinaBackgroundEtanercept biosimilar recombinant human TNF-α receptor II: IgG Fc fusion protein (rhTNFR-Fc) has showed its efficacy and safety in Chinese patients with rheumatoid arthritis. However, data on rhTNFR-Fc's application in juvenile idiopathic arthritis (JIA) is limited.MethodsA prospective, observational, multicenter study was performed at 6 institutes in China from July 2020 to December 2021. In a 24-week follow-up, patients with JIA including polyarticular JIA and enthesitis related arthritis received rhTNFR-Fc plus methotrexate (MTX) treatment. The primary outcome parameters were improvements of cJADAS-10 (clinical Juvenile Arthritis Disease Activity Score), and the secondary outcome parameter was an inactive disease.Results60 patients completed at least 12-week follow-up, and 57 completed 24-week follow-up. They had high C reactive protein values (11.6 mg/L) and cJADAS-10 (14.6) at baseline. Thirteen patients had morning stiffness. 33 patients showed synovial thickening, and 34 showed bone marrow edemas on MRI. Ultrasonography demonstrated significant joint effusions in 43 patients. The cJADAS-10 sharply decreased from 14.66 at the baseline to 2.4 at 24 weeks of rhTNFR-Fc therapy, respectively (P < 0.01). About half of patients achieved inactive disease at 24 weeks of therapy. Compared with the baseline, the number of patients with morning stiffness, joint effusions, bone marrow edema and synovial thickening on MRI significantly decreased at 24 weeks. Adverse events were consistent with known side effects of biologic agents.ConclusionsThe present study indicated that the combination of rhTNFR-Fc and MTX significantly improve symptoms and disease activity of children with JIA. This study suggests etanercept biosimilar rhTNFR-Fc as an effective and safe therapy for children with JIA.https://www.frontiersin.org/articles/10.3389/fped.2022.992932/fulljuvenile idiopathic arthritisetanercept biosimilardisease activityefficacysafety |
| spellingShingle | Xuefeng Xu Xiaohui Liu Wenjie Zheng Jihong Xiao Xiaozhong Li Ling Wu Lixia Zou Qian Ouyang Yaoyao Shangguan Kezhao Lin Xiaomei Dai Yuanling Chen Yiping Xu Jianqiang Wu Meiping Lu Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study Frontiers in Pediatrics juvenile idiopathic arthritis etanercept biosimilar disease activity efficacy safety |
| title | Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study |
| title_full | Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study |
| title_fullStr | Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study |
| title_full_unstemmed | Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study |
| title_short | Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study |
| title_sort | efficacy and safety of etanercept biosimilar rhtnfr fc in chinese patients with juvenile idiopathic arthritis an open label multicenter observational study |
| topic | juvenile idiopathic arthritis etanercept biosimilar disease activity efficacy safety |
| url | https://www.frontiersin.org/articles/10.3389/fped.2022.992932/full |
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