Comparison of the impact of Tripterygium wilfordii Hook F and Methotrexate treatment on radiological progression in active rheumatoid arthritis: 2-year follow up of a randomized, non-blinded, controlled study

作者：Yangzhong Zhou, Lidan Zhao, Hua Chen, Yan Zhang, Danfeng Wang, Linfang Huang, Qianwen Lv, Bin Liu, Zhenbin Li, Wei Wei, Hongbin Li, Xiangping Liao, Hui Liu, Xiumei Liu, Hongtao Jin, Junxiang Wang, Yun-yun Fei, Qingjun Wu, Wen Zhang, Qun Shi, Wenjie Zheng, Fengchun Zhang, Fu-lin Tang, Peter E. Lipsky, Xuan Zhang · 发表于：Arthritis Research & Therapy · 年份：2018 · DOI：10.1186/s13075-018-1563-6 · 被引用次数：77 · 研究领域：Natural Compounds in Disease Treatment、Rheumatoid Arthritis Research and Therapies、Autoimmune and Inflammatory Disorders Research

BACKGROUND: Tripterygium wilfordii Hook F (TwHF) alone or in combination with methotrexate (MTX) has been shown to be more effective than MTX monotherapy in controlling the manifestations in subjects with disease-modifying antirheumatic drug (DMARD)-naïve active rheumatoid arthritis (RA) over a 6-month period. The long-term impact of these therapies on disease activity and radiographic progression in RA has not been examined. METHODS: Patients with DMARD-naïve RA enrolled in the "Comparison of Tripterygium wilfordii Hook F with methotrexate in the Treatment of Active Rheumatoid Arthritis" (TRIFRA) study were randomly allocated into three arms with TwHF or MTX or the two in combination. Clinical indexes and radiographic data at baseline and year 2 was collected and compared using an intent-to-treat (ITT) and a per-protocol (PP) analysis. Two radiologists blinded to the treatment scored the images independently. RESULTS: Of 207 subjects 109 completed the 2-year follow up. The number of subjects withdrawing from the study and the number adhering to the initial regimens were similar among the three groups (p > = 0.05). In the ITT analysis, proportions of patients reaching American College of Rheumatology 50% (ACR50) response criteria were 46.4%, 58.0% and 50.7% in the MTX, TwHF and MTX + TwHF groups (TwHF vs MTX monotherapy, p = 0.004). Similar patterns were found in ACR20, ACR70, Clinical Disease Activity Index good responses, European League Against Rheumatism good response, re...