Can Methotrexate Monotherapy Achieve Clinical Remission in Patients with Active Rheumatoid Arthritis? A Model-Based Meta-Analysis.

IF 2.9 4区 医学
Shengyang Chen, Yangrui Wu, Wei Huang, Jianxing Zhou, Zipeng Wei, Xuemei Wu
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Abstract

This study utilized model-based meta-analysis (MBMA) to systematically assess the efficacy of methotrexate (MTX) monotherapy in improving rheumatoid arthritis (RA) symptoms and function. The assessment was based on indicators such as Disease Activity Score 28 (DAS28), Health Assessment Questionnaire, and American College of Rheumatology (ACR) criteria. Additionally, the study investigated the impact of dosage, disease duration, and serum markers-C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)-on treatment efficacy. A systematic review of randomized controlled trials yielded data from 69 studies involving 7999 patients. Efficacy models for DAS28, ACR20, and ACR50 were developed to explore the impact of time and dosage, with simulations conducted to predict outcomes at 12 weeks. Results showed that the maximum reduction in DAS28 (Emax) was -54.90% (RSE: 13%), with an ET50 of 20.6 weeks (RSE: 26%). For ACR20 and ACR50, Emax values were 70.3% (RSE: 3%) and 49.4% (RSE: 24%), with ET50s of 6.69 (RSE: 7%) and 27.3 (RSE: 37%) weeks, respectively. Neither dosage nor patient-specific factors like disease duration, CRP, or ESR significantly influenced efficacy. MTX is effective in the early treatment of RA but often fails to achieve remission in patients.

甲氨蝶呤单药治疗活动性类风湿关节炎能否获得临床缓解?基于模型的元分析。
本研究利用基于模型的荟萃分析(MBMA)系统评估甲氨蝶呤(MTX)单药治疗改善类风湿性关节炎(RA)症状和功能的疗效。评估基于疾病活动评分28 (DAS28)、健康评估问卷和美国风湿病学会(ACR)标准等指标。此外,研究还探讨了剂量、病程、血清标志物- c反应蛋白(CRP)和红细胞沉降率(ESR)对治疗效果的影响。一项对随机对照试验的系统回顾得出了涉及7999名患者的69项研究的数据。建立了DAS28、ACR20和ACR50的疗效模型,以探讨时间和剂量的影响,并进行了模拟以预测12周的结果。结果显示,DAS28 (Emax)的最大降幅为-54.90% (RSE: 13%), ET50为20.6周(RSE: 26%)。ACR20和ACR50的Emax值分别为70.3% (RSE: 3%)和49.4% (RSE: 24%), et50分别为6.69 (RSE: 7%)和27.3 (RSE: 37%)周。剂量和患者特异性因素如病程、CRP或ESR均未显著影响疗效。甲氨蝶呤是有效的早期治疗类风湿性关节炎,但往往不能达到缓解患者。
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来源期刊
Journal of Clinical Pharmacology
Journal of Clinical Pharmacology PHARMACOLOGY & PHARMACY-
自引率
3.40%
发文量
0
期刊介绍: The Journal of Clinical Pharmacology (JCP) is a Human Pharmacology journal designed to provide physicians, pharmacists, research scientists, regulatory scientists, drug developers and academic colleagues a forum to present research in all aspects of Clinical Pharmacology. This includes original research in pharmacokinetics, pharmacogenetics/pharmacogenomics, pharmacometrics, physiologic based pharmacokinetic modeling, drug interactions, therapeutic drug monitoring, regulatory sciences (including unique methods of data analysis), special population studies, drug development, pharmacovigilance, womens’ health, pediatric pharmacology, and pharmacodynamics. Additionally, JCP publishes review articles, commentaries and educational manuscripts. The Journal also serves as an instrument to disseminate Public Policy statements from the American College of Clinical Pharmacology.
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