Efficacy and safety of tripterygium wilfordii Hook F plus TNF inhibitor for active rheumatoid arthritis A multicentre, randomized, double-blind, triple-dummy controlled trial

Efficacy and safety of tripterygium wilfordii Hook F plus TNF inhibitor for active rheumatoid arthritis : A multicentre, randomized, double-blind, triple-dummy controlled trial

Copyright © 2023. Published by Elsevier Inc.

Bibliographische Detailangaben
Veröffentlicht in:Clinical immunology (Orlando, Fla.). - 1999. - 255(2023) vom: 30. Okt., Seite 109749
1. Verfasser: Zhang, Xuan (VerfasserIn)
Weitere Verfasser: Yang, Huaxia, Zuo, Xiaoxia, Wu, Lijun, Peng, Jiangyun, Li, Zhenbin, Li, Hongbin, Ji, Wei, Zhang, Liyun, Li, Xiaomei, Dai, Lie, Lu, Liangjing, Yang, Niansheng, Wei, Wei, Shuai, Zongwen, Jiang, Ying, Liu, Yudong, Lipsky, Peter E, Chen, Hua, YISTAR study group
Format: Online-Aufsatz
Sprache:English
Veröffentlicht: 2023
Zugriff auf das übergeordnete Werk:Clinical immunology (Orlando, Fla.)
Schlagworte:Journal Article Rheumatoid arthritis TNF receptor IgGFc fusion protein Tripterygium wilfordii Hook F
Beschreibung
Zusammenfassung:Copyright © 2023. Published by Elsevier Inc.
An investigator-initiated, multicentre, randomized, double-blind, triple-dummy, controlled trial was conducted at 14 tertiary rheumatology centers in China to evaluate the efficacy and safety of Tripterygium wilfordii Hook F (TwHF) with recombinant human TNF receptor IgGFc fusion protein (rhTNFR-Fc) in active Rheumatoid Arthritis (RA). Primary endpoint was the proportion of patients achieved a 50% improvement of American College of Rheumatology criteria (ACR50) in TwHF+rhTNFR-Fc vs. methotrexate (MTX) group at week 12. ACR50 was achieved in 57.1% (72/126), 41.3% (52/126), 23.0% (29/126), and 26.2% (33/126) patients receiving TwHF+rhTNFR-Fc, MTX + rhTNFR-Fc, TwHF and MTX monotherapy, respectively, at week 12 (TwHF+rhTNFR-Fc vs. other three groups, all p < 0.05). No statistical difference in serious adverse events or adverse events leading to discontinuation of study across all groups was documented. TwHF+rhTNFR-Fc was superior to MTX for active RA, and was more effective than MTX + rhTNFR-Fc on ACR50, with a similar safety profile. Trial registration:ClinicalTrials.govNCT03589833
Beschreibung:Date Revised 28.09.2023
published: Print-Electronic
ClinicalTrials.gov: NCT03589833
Citation Status Publisher
ISSN:1521-7035
DOI:10.1016/j.clim.2023.109749