Sorbonne University, Pierre Louis Institute for Epidemiology and Public Health; Assistance Publique Hopitaux de Paris, Pitie-Salpetriere University Hospital, Rheumatology Dept, Paris, France.
Eli Lilly and Company, Indianapolis, Indiana, USA.
RMD Open. 2020 Apr;6(1). doi: 10.1136/rmdopen-2019-001131.
To compare improvement in pain and physical function for patients treated with baricitinib, adalimumab, tocilizumab and tofacitinib monotherapy from randomised, methotrexate (MTX)-controlled trials in conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)/biologic (bDMARD)-naïve RA patients using matching-adjusted indirect comparisons (MAICs).
Data were from Phase III trials on patients receiving monotherapy baricitinib, tocilizumab, adalimumab, tofacitinib or MTX. Pain was assessed using a visual analogue scale (0-100 mm) and physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI). An MAIC based on treatment-arm matching, an MAIC with study-level matching and Bucher's method without matching compared change in outcomes between therapies. Matching variables included age, gender, baseline disease activity and baseline value of outcome measure.
With all methods, greater improvements were observed in pain and HAQ-DI at 6 months for baricitinib compared with adalimumab and tocilizumab (<0.05). Differences in treatment effects (TEs) favouring baricitinib for pain VAS for treatment-arm matching, study-level matching and Bucher's method, respectively, were -12, -12 and -12 for baricitinib versus adalimumab and -7, -7 and -9 for baricitinib versus tocilizumab; the difference in TEs for HAQ-DI was -0.28, -0.28 and -0.30 for adalimumab and -0.23, -0.23 and -0.26 for tocilizumab. For baricitinib versus tofacitinib, no statistically significant differences for pain improvement were observed except with one of the three methods (Bucher method) and none for HAQ-DI.
Results suggest greater pain reduction and improved physical function for baricitinib monotherapy compared with tocilizumab and adalimumab monotherapy. No statistically significant differences in pain reduction and improved physical function were observed between baricitinib and tofacitinib with the MAIC analyses.
通过匹配调整间接比较（MAIC），比较在接受巴利昔单抗、阿达木单抗、托珠单抗和托法替布单药治疗的随机、甲氨蝶呤（MTX）对照试验中，与传统合成改善病情抗风湿药（csDMARDs）/生物制剂（bDMARD）初治 RA 患者的疼痛改善和身体功能。
数据来自接受巴利昔单抗、托珠单抗、阿达木单抗、托法替布或 MTX 单药治疗的 III 期试验。疼痛采用视觉模拟量表（0-100mm）评估，身体功能采用健康评估问卷残疾指数（HAQ-DI）。基于治疗臂匹配的 MAIC、基于研究水平匹配的 MAIC 和 Bucher 法无匹配比较治疗之间结局的变化。匹配变量包括年龄、性别、基线疾病活动度和基线结局测量值。
采用所有方法，与阿达木单抗和托珠单抗相比，巴利昔单抗在 6 个月时疼痛和 HAQ-DI 改善更大（<0.05）。治疗效果（TE）有利于巴利昔单抗的差异，在治疗臂匹配、研究水平匹配和 Bucher 法中，巴利昔单抗与阿达木单抗的分别为-12、-12 和-12，巴利昔单抗与托珠单抗的分别为-7、-7 和-9；阿达木单抗与托珠单抗的分别为-0.28、-0.28 和-0.30，托珠单抗与托法替布的分别为-0.23、-0.23 和-0.26。对于巴利昔单抗与托法替布，除一种方法（Bucher 法）外，疼痛改善无统计学差异，HAQ-DI 也无统计学差异。
结果表明，与托珠单抗和阿达木单抗单药治疗相比，巴利昔单抗单药治疗可显著减轻疼痛，改善身体功能。MAIC 分析显示，巴利昔单抗与托法替布在疼痛减轻和身体功能改善方面无统计学差异。
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