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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Autor*in:	Xuefeng Xu [verfasserIn] Xiaohui Liu [verfasserIn] Wenjie Zheng [verfasserIn] Jihong Xiao [verfasserIn] Xiaozhong Li [verfasserIn] Ling Wu [verfasserIn] Lixia Zou [verfasserIn] Qian Ouyang [verfasserIn] Yaoyao Shangguan [verfasserIn] Kezhao Lin [verfasserIn] Xiaomei Dai [verfasserIn] Yuanling Chen [verfasserIn] Yiping Xu [verfasserIn] Jianqiang Wu [verfasserIn] Meiping Lu [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	juvenile idiopathic arthritis etanercept biosimilar disease activity efficacy safety

Übergeordnetes Werk:	In: Frontiers in Pediatrics - Frontiers Media S.A., 2013, 10(2022)
Übergeordnetes Werk:	volume:10 ; year:2022

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.3389/fped.2022.992932

Katalog-ID:	DOAJ084439653

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520			\|a 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.
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allfields	10.3389/fped.2022.992932 doi (DE-627)DOAJ084439653 (DE-599)DOAJ3b06fc655e954e5092ea55b0b8386fe9 DE-627 ger DE-627 rakwb eng RJ1-570 Xuefeng Xu verfasserin aut Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. juvenile idiopathic arthritis etanercept biosimilar disease activity efficacy safety Pediatrics Xiaohui Liu verfasserin aut Wenjie Zheng verfasserin aut Jihong Xiao verfasserin aut Xiaozhong Li verfasserin aut Ling Wu verfasserin aut Lixia Zou verfasserin aut Qian Ouyang verfasserin aut Yaoyao Shangguan verfasserin aut Kezhao Lin verfasserin aut Xiaomei Dai verfasserin aut Yuanling Chen verfasserin aut Yiping Xu verfasserin aut Jianqiang Wu verfasserin aut Meiping Lu verfasserin aut In Frontiers in Pediatrics Frontiers Media S.A., 2013 10(2022) (DE-627)742738744 (DE-600)2711999-3 22962360 nnns volume:10 year:2022 https://doi.org/10.3389/fped.2022.992932 kostenfrei https://doaj.org/article/3b06fc655e954e5092ea55b0b8386fe9 kostenfrei https://www.frontiersin.org/articles/10.3389/fped.2022.992932/full kostenfrei https://doaj.org/toc/2296-2360 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2022
spelling	10.3389/fped.2022.992932 doi (DE-627)DOAJ084439653 (DE-599)DOAJ3b06fc655e954e5092ea55b0b8386fe9 DE-627 ger DE-627 rakwb eng RJ1-570 Xuefeng Xu verfasserin aut Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. juvenile idiopathic arthritis etanercept biosimilar disease activity efficacy safety Pediatrics Xiaohui Liu verfasserin aut Wenjie Zheng verfasserin aut Jihong Xiao verfasserin aut Xiaozhong Li verfasserin aut Ling Wu verfasserin aut Lixia Zou verfasserin aut Qian Ouyang verfasserin aut Yaoyao Shangguan verfasserin aut Kezhao Lin verfasserin aut Xiaomei Dai verfasserin aut Yuanling Chen verfasserin aut Yiping Xu verfasserin aut Jianqiang Wu verfasserin aut Meiping Lu verfasserin aut In Frontiers in Pediatrics Frontiers Media S.A., 2013 10(2022) (DE-627)742738744 (DE-600)2711999-3 22962360 nnns volume:10 year:2022 https://doi.org/10.3389/fped.2022.992932 kostenfrei https://doaj.org/article/3b06fc655e954e5092ea55b0b8386fe9 kostenfrei https://www.frontiersin.org/articles/10.3389/fped.2022.992932/full kostenfrei https://doaj.org/toc/2296-2360 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2022
allfields_unstemmed	10.3389/fped.2022.992932 doi (DE-627)DOAJ084439653 (DE-599)DOAJ3b06fc655e954e5092ea55b0b8386fe9 DE-627 ger DE-627 rakwb eng RJ1-570 Xuefeng Xu verfasserin aut Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. juvenile idiopathic arthritis etanercept biosimilar disease activity efficacy safety Pediatrics Xiaohui Liu verfasserin aut Wenjie Zheng verfasserin aut Jihong Xiao verfasserin aut Xiaozhong Li verfasserin aut Ling Wu verfasserin aut Lixia Zou verfasserin aut Qian Ouyang verfasserin aut Yaoyao Shangguan verfasserin aut Kezhao Lin verfasserin aut Xiaomei Dai verfasserin aut Yuanling Chen verfasserin aut Yiping Xu verfasserin aut Jianqiang Wu verfasserin aut Meiping Lu verfasserin aut In Frontiers in Pediatrics Frontiers Media S.A., 2013 10(2022) (DE-627)742738744 (DE-600)2711999-3 22962360 nnns volume:10 year:2022 https://doi.org/10.3389/fped.2022.992932 kostenfrei https://doaj.org/article/3b06fc655e954e5092ea55b0b8386fe9 kostenfrei https://www.frontiersin.org/articles/10.3389/fped.2022.992932/full kostenfrei https://doaj.org/toc/2296-2360 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2022
allfieldsGer	10.3389/fped.2022.992932 doi (DE-627)DOAJ084439653 (DE-599)DOAJ3b06fc655e954e5092ea55b0b8386fe9 DE-627 ger DE-627 rakwb eng RJ1-570 Xuefeng Xu verfasserin aut Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. juvenile idiopathic arthritis etanercept biosimilar disease activity efficacy safety Pediatrics Xiaohui Liu verfasserin aut Wenjie Zheng verfasserin aut Jihong Xiao verfasserin aut Xiaozhong Li verfasserin aut Ling Wu verfasserin aut Lixia Zou verfasserin aut Qian Ouyang verfasserin aut Yaoyao Shangguan verfasserin aut Kezhao Lin verfasserin aut Xiaomei Dai verfasserin aut Yuanling Chen verfasserin aut Yiping Xu verfasserin aut Jianqiang Wu verfasserin aut Meiping Lu verfasserin aut In Frontiers in Pediatrics Frontiers Media S.A., 2013 10(2022) (DE-627)742738744 (DE-600)2711999-3 22962360 nnns volume:10 year:2022 https://doi.org/10.3389/fped.2022.992932 kostenfrei https://doaj.org/article/3b06fc655e954e5092ea55b0b8386fe9 kostenfrei https://www.frontiersin.org/articles/10.3389/fped.2022.992932/full kostenfrei https://doaj.org/toc/2296-2360 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2022
allfieldsSound	10.3389/fped.2022.992932 doi (DE-627)DOAJ084439653 (DE-599)DOAJ3b06fc655e954e5092ea55b0b8386fe9 DE-627 ger DE-627 rakwb eng RJ1-570 Xuefeng Xu verfasserin aut Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. juvenile idiopathic arthritis etanercept biosimilar disease activity efficacy safety Pediatrics Xiaohui Liu verfasserin aut Wenjie Zheng verfasserin aut Jihong Xiao verfasserin aut Xiaozhong Li verfasserin aut Ling Wu verfasserin aut Lixia Zou verfasserin aut Qian Ouyang verfasserin aut Yaoyao Shangguan verfasserin aut Kezhao Lin verfasserin aut Xiaomei Dai verfasserin aut Yuanling Chen verfasserin aut Yiping Xu verfasserin aut Jianqiang Wu verfasserin aut Meiping Lu verfasserin aut In Frontiers in Pediatrics Frontiers Media S.A., 2013 10(2022) (DE-627)742738744 (DE-600)2711999-3 22962360 nnns volume:10 year:2022 https://doi.org/10.3389/fped.2022.992932 kostenfrei https://doaj.org/article/3b06fc655e954e5092ea55b0b8386fe9 kostenfrei https://www.frontiersin.org/articles/10.3389/fped.2022.992932/full kostenfrei https://doaj.org/toc/2296-2360 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2022
language	English
source	In Frontiers in Pediatrics 10(2022) volume:10 year:2022
sourceStr	In Frontiers in Pediatrics 10(2022) volume:10 year:2022
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	juvenile idiopathic arthritis etanercept biosimilar disease activity efficacy safety Pediatrics
isfreeaccess_bool	true
container_title	Frontiers in Pediatrics
authorswithroles_txt_mv	Xuefeng Xu @@aut@@ Xiaohui Liu @@aut@@ Wenjie Zheng @@aut@@ Jihong Xiao @@aut@@ Xiaozhong Li @@aut@@ Ling Wu @@aut@@ Lixia Zou @@aut@@ Qian Ouyang @@aut@@ Yaoyao Shangguan @@aut@@ Kezhao Lin @@aut@@ Xiaomei Dai @@aut@@ Yuanling Chen @@aut@@ Yiping Xu @@aut@@ Jianqiang Wu @@aut@@ Meiping Lu @@aut@@
publishDateDaySort_date	2022-01-01T00:00:00Z
hierarchy_top_id	742738744
id	DOAJ084439653
language_de	englisch
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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 &lt; 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. 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callnumber-first	R - Medicine
author	Xuefeng Xu
spellingShingle	Xuefeng Xu misc RJ1-570 misc juvenile idiopathic arthritis misc etanercept biosimilar misc disease activity misc efficacy misc safety misc Pediatrics Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study
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topic_title	RJ1-570 Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study juvenile idiopathic arthritis etanercept biosimilar disease activity efficacy safety
topic	misc RJ1-570 misc juvenile idiopathic arthritis misc etanercept biosimilar misc disease activity misc efficacy misc safety misc Pediatrics
topic_unstemmed	misc RJ1-570 misc juvenile idiopathic arthritis misc etanercept biosimilar misc disease activity misc efficacy misc safety misc Pediatrics
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title	Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study
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title_full	Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study
author_sort	Xuefeng Xu
journal	Frontiers in Pediatrics
journalStr	Frontiers in Pediatrics
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author_browse	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
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doi_str_mv	10.3389/fped.2022.992932
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title_sort	efficacy and safety of etanercept biosimilar rhtnfr-fc in chinese patients with juvenile idiopathic arthritis: an open-label multicenter observational study
callnumber	RJ1-570
title_auth	Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study
abstract	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.
abstractGer	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.
abstract_unstemmed	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.
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title_short	Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study
url	https://doi.org/10.3389/fped.2022.992932 https://doaj.org/article/3b06fc655e954e5092ea55b0b8386fe9 https://www.frontiersin.org/articles/10.3389/fped.2022.992932/full https://doaj.org/toc/2296-2360
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author2	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
author2Str	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
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Efficacy and safety of etanercept biosimilar rhTNFR-Fc in Chinese patients with juvenile idiopathic arthritis: An open-label multicenter observational study

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