巴瑞替尼治疗类风湿关节炎患者的患者报告结局，这些患者既往无或有限的疾病修正抗风湿药物治疗。
Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment.
机构信息
University of Colorado School of Medicine, Denver, CO, 80045, USA.
Keio University, Tokyo, Japan.
出版信息
Arthritis Res Ther. 2017 Sep 18;19(1):208. doi: 10.1186/s13075-017-1410-1.
BACKGROUND
This study evaluates patient-reported outcomes (PROs) in a double-blind, phase III study of baricitinib as monotherapy or combined with methotrexate (MTX) in patients with active rheumatoid arthritis (RA) with no or minimal prior conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and naïve to biological DMARDs.
METHODS
Patients were randomized 4:3:4 to MTX administered once weekly (N = 210), baricitinib monotherapy (4 mg once daily (QD), N = 159), or combination of baricitinib (4 mg QD) and MTX (baricitinib + MTX, N = 215). PROs included the Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration of morning joint stiffness (MJS), worst joint pain, worst tiredness, Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA), Short Form 36 version 2, Acute (SF-36); and EuroQol 5-Dimensions (EQ-5D) Health State Profile. Comparisons were assessed with analysis of covariance (ANCOVA) and logistic regression models.
RESULTS
Compared to MTX, patients in both baricitinib groups reported greater improvement (p ≤ 0.01) in HAQ-DI, PtGA, pain, fatigue, worst join pain, SF-36 physical component score, and EQ-5D at weeks 24 and 52. For the SF-36 mental component score, patients in both baricitinib groups reported statistically significant improvements (p ≤ 0.01) at week 52 compared to MTX-treated patients. Statistically significant improvements (p ≤ 0.05) were observed with the WPAI-RA for the baricitinib groups vs. MTX at week 24 and for the WPAI-RA daily activity and work productivity measures for baricitinib + MTX at week 52.
CONCLUSIONS
In this study, baricitinib alone or in combination with MTX, when used as initial therapy, resulted in significant improvement compared to MTX in the majority of the pre-specified PRO measures.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT01711359 . Registered on 18 October 2012.
背景
本研究评估了巴利昔替尼单药或联合甲氨蝶呤（MTX）在既往接受传统合成改善病情抗风湿药物（csDMARDs）治疗最少或无治疗、且对生物 DMARDs 初治的活动期类风湿关节炎（RA）患者中的患者报告结局（PROs），这些患者为双盲、III 期研究的入组患者。
方法
患者按 4:3:4 的比例随机分配至每周一次接受 MTX 治疗（N=210）、巴利昔替尼单药治疗（4mg 每日一次（QD），N=159）或巴利昔替尼联合 MTX 治疗（巴利昔替尼+MTX，N=215）。PROs 包括患者的整体疾病活动评估（PtGA）、患者对疼痛的评估、健康评估问卷残疾指数（HAQ-DI）、慢性疾病治疗疲劳功能评估-疲乏量表（FACIT-F）、晨僵时间（MJS）、最严重关节痛、最严重疲乏、工作效率和活动障碍-类风湿关节炎量表（WPAI-RA）、简化 36 健康调查量表第 2 版（SF-36）；以及欧洲五维健康量表（EQ-5D）健康状态简表。采用协方差分析（ANCOVA）和逻辑回归模型进行比较。
结果
与 MTX 相比，两组巴利昔替尼治疗组患者在第 24 周和第 52 周时报告 HAQ-DI、PtGA、疼痛、疲劳、最严重关节痛、SF-36 生理成分评分和 EQ-5D 改善更显著（p≤0.01）。在第 52 周时，两组巴利昔替尼治疗组患者的 SF-36 心理成分评分较 MTX 治疗组显著改善（p≤0.01）。在第 24 周时，巴利昔替尼组患者的 WPAI-RA 中的工作效率和日常活动能力指标与 MTX 相比有统计学意义的改善（p≤0.05），在第 52 周时，巴利昔替尼+MTX 组患者的 WPAI-RA 工作效率和日常活动能力指标与 MTX 相比有统计学意义的改善（p≤0.05）。
结论
在这项研究中，巴利昔替尼单药或联合 MTX 作为初始治疗药物，与 MTX 相比，在大多数预先指定的 PRO 测量指标中均显著改善。
试验注册
ClinicalTrials.gov，NCT01711359。于 2012 年 10 月 18 日注册。
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