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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

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-mo...

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Autores principales: Zhou, Yang-zhong, Zhao, Li-dan, Chen, Hua, Zhang, Yan, Wang, Dan-feng, Huang, Lin-fang, Lv, Qian-wen, Liu, Bin, Li, Zhenbin, Wei, Wei, Li, Hongbin, Liao, Xiangping, Liu, Hui, Liu, Xiumei, Jin, Hongtao, Wang, Junxiang, Fei, Yun-yun, Wu, Qing-jun, Zhang, Wen, Shi, Qun, Zheng, Wen-jie, Zhang, Feng-chun, Tang, Fu-lin, Lipsky, Peter E., Zhang, Xuan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5894170/
https://www.ncbi.nlm.nih.gov/pubmed/29636089
http://dx.doi.org/10.1186/s13075-018-1563-6
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author Zhou, Yang-zhong
Zhao, Li-dan
Chen, Hua
Zhang, Yan
Wang, Dan-feng
Huang, Lin-fang
Lv, Qian-wen
Liu, Bin
Li, Zhenbin
Wei, Wei
Li, Hongbin
Liao, Xiangping
Liu, Hui
Liu, Xiumei
Jin, Hongtao
Wang, Junxiang
Fei, Yun-yun
Wu, Qing-jun
Zhang, Wen
Shi, Qun
Zheng, Wen-jie
Zhang, Feng-chun
Tang, Fu-lin
Lipsky, Peter E.
Zhang, Xuan
author_facet Zhou, Yang-zhong
Zhao, Li-dan
Chen, Hua
Zhang, Yan
Wang, Dan-feng
Huang, Lin-fang
Lv, Qian-wen
Liu, Bin
Li, Zhenbin
Wei, Wei
Li, Hongbin
Liao, Xiangping
Liu, Hui
Liu, Xiumei
Jin, Hongtao
Wang, Junxiang
Fei, Yun-yun
Wu, Qing-jun
Zhang, Wen
Shi, Qun
Zheng, Wen-jie
Zhang, Feng-chun
Tang, Fu-lin
Lipsky, Peter E.
Zhang, Xuan
author_sort Zhou, Yang-zhong
collection PubMed
description 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, remission rate and low disease activity rate at year 2. The results of the PP analysis agreed with those in the ITT analysis. The changes in total Sharp scores and joint erosion and joint space narrowing during the 2 years were associated with changes in disease activity measured by the 28-joint count Disease Activity Score and were comparable among the three groups (p > 0.05). Adverse events were similar in the three treatment groups. CONCLUSIONS: During the 2-year therapy period, TwHF monotherapy was not inferior to MTX monotherapy in controlling disease activity and retarding radiological progression in patients with active RA. TRIAL REGISTRATION: This is a follow-up study. Original trial registration: ClinicalTrials.gov, NCT01613079. Registered on 4 June 2012.
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spelling pubmed-58941702018-04-12 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 Zhou, Yang-zhong Zhao, Li-dan Chen, Hua Zhang, Yan Wang, Dan-feng Huang, Lin-fang Lv, Qian-wen Liu, Bin Li, Zhenbin Wei, Wei Li, Hongbin Liao, Xiangping Liu, Hui Liu, Xiumei Jin, Hongtao Wang, Junxiang Fei, Yun-yun Wu, Qing-jun Zhang, Wen Shi, Qun Zheng, Wen-jie Zhang, Feng-chun Tang, Fu-lin Lipsky, Peter E. Zhang, Xuan Arthritis Res Ther Research Article 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, remission rate and low disease activity rate at year 2. The results of the PP analysis agreed with those in the ITT analysis. The changes in total Sharp scores and joint erosion and joint space narrowing during the 2 years were associated with changes in disease activity measured by the 28-joint count Disease Activity Score and were comparable among the three groups (p > 0.05). Adverse events were similar in the three treatment groups. CONCLUSIONS: During the 2-year therapy period, TwHF monotherapy was not inferior to MTX monotherapy in controlling disease activity and retarding radiological progression in patients with active RA. TRIAL REGISTRATION: This is a follow-up study. Original trial registration: ClinicalTrials.gov, NCT01613079. Registered on 4 June 2012. BioMed Central 2018-04-10 2018 /pmc/articles/PMC5894170/ /pubmed/29636089 http://dx.doi.org/10.1186/s13075-018-1563-6 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Zhou, Yang-zhong
Zhao, Li-dan
Chen, Hua
Zhang, Yan
Wang, Dan-feng
Huang, Lin-fang
Lv, Qian-wen
Liu, Bin
Li, Zhenbin
Wei, Wei
Li, Hongbin
Liao, Xiangping
Liu, Hui
Liu, Xiumei
Jin, Hongtao
Wang, Junxiang
Fei, Yun-yun
Wu, Qing-jun
Zhang, Wen
Shi, Qun
Zheng, Wen-jie
Zhang, Feng-chun
Tang, Fu-lin
Lipsky, Peter E.
Zhang, Xuan
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5894170/
https://www.ncbi.nlm.nih.gov/pubmed/29636089
http://dx.doi.org/10.1186/s13075-018-1563-6
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