Emery Paul, Blanco Ricardo, Maldonado Cocco Jose, Chen Ying-Chou, Gaich Carol L, DeLozier Amy M, de Bono Stephanie, Liu Jiajun, Rooney Terence, Chang Cecile Hsiao-Chun, Dougados Maxime
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds , Leeds , UK.
Department of Rheumatology , Hospital Universitario Marqués de Valdecilla, IDIVAL , Santander, Cantabria , Spain.
RMD Open. 2017 Mar 21;3(1):e000410. doi: 10.1136/rmdopen-2016-000410. eCollection 2017.
To evaluate the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis (RA) and an inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs.
In this phase III study, patients were randomised 1:1:1 to placebo (N=228), baricitinib 2 mg once daily (QD, N=229) or baricitinib 4 mg QD (N=227). PROs included the Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, measures from patient electronic daily diaries (duration and severity of morning joint stiffness (MJS), Worst Tiredness, Worst Joint Pain), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), SF-36, EuroQol 5-D index scores and visual analogue scales (VAS) and the Work Productivity and Activity Impairment Questionnaire-RA. The primary time point for the study was week 12. Treatment comparisons were assessed with logistic regression for categorical measures and analysis of covariance for continuous variables.
Statistically significant improvements were observed for both baricitinib groups versus placebo in HAQ-DI, PtGA, pain, daily diary measures, EuroQoL index scores and SF-36 physical component score at week 12 and for those measures when assessed at week 24. Baricitinib 2 mg and baricitinib 4 mg were statistically significantly improved versus placebo for the EuroQoL VAS and FACIT-F, respectively, at week 24.
Baricitinib 2 or 4 mg provided significant improvement versus placebo in PROs across different domains of RA, including physical function, MJS, fatigue, pain and quality of life.
NCT01721057; Results.
评估巴瑞替尼对活动性类风湿关节炎（RA）患者且对传统合成改善病情抗风湿药物反应不足或不耐受的患者报告结局（PROs）的影响。
在这项III期研究中，患者按1:1:1随机分组至安慰剂组（N = 228）、巴瑞替尼2mg每日一次（QD，N = 229）或巴瑞替尼4mg QD（N = 227）。PROs包括健康评估问卷残疾指数（HAQ-DI）、患者对疾病活动的整体评估（PtGA）、患者对疼痛的评估、患者电子日记中的测量指标（晨僵（MJS）的持续时间和严重程度、最严重疲劳、最严重关节疼痛）、慢性病治疗功能评估-疲劳（FACIT-F）、SF-36、欧洲五维健康量表指数评分和视觉模拟量表（VAS）以及工作效率和活动障碍问卷-RA。研究的主要时间点为第12周。采用逻辑回归分析分类指标的治疗组间差异，采用协方差分析连续变量的治疗组间差异。
在第12周时，巴瑞替尼两个治疗组在HAQ-DI、PtGA、疼痛、日记测量指标、欧洲五维健康量表指数评分和SF-36身体成分评分方面与安慰剂组相比均有统计学意义的改善，在第24周评估这些指标时同样如此。在第24周时，巴瑞替尼2mg组和巴瑞替尼4mg组在欧洲五维健康量表VAS和FACIT-F方面分别与安慰剂组相比有统计学意义的改善。
2mg或4mg巴瑞替尼与安慰剂相比，在RA的不同领域的PROs方面有显著改善，包括身体功能、MJS、疲劳、疼痛和生活质量。
NCT01721057；结果
