Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial.
Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial.
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DOI：
10.1136/annrheumdis-2016-210310
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发表时间：
2017-05
影响因子：
27.4
通讯作者：
Lee EB
中科院分区：
文献类型：
--
作者：
Burmester GR;Lin Y;Patel R;van Adelsberg J;Mangan EK;Graham NM;van Hoogstraten H;Bauer D;Ignacio Vargas J;Lee EB
比较sar单药治疗与阿达木单抗单药治疗因不耐受或疗效不充分而不应继续接受甲氨蝶呤（MTX）治疗的活动性类风湿关节炎（RA）患者的疗效和安全性。MONTAGE是一项随机、活性对照、双盲、双模拟、III期优效性试验。患者接受sar（200 mg每2周一次（q2 w））或阿达木单抗（40 mg q2 w）单药治疗24周。 主要终点是第24周时使用红细胞沉降率（DAS 28-ESR）进行的28关节疾病活动度评分较基线的变化。在DAS 28-ESR较基线变化的主要终点方面，Sar优于阿达木单抗（上级）（−3.28 vs −2.20; p<0.0001）。Sar单抗治疗患者的美国流变学学会20/50/70缓解率显著更高（Sar：71.7%/45.7%/23.4%;阿达木单抗：58.4%/29.7%/11.9%;所有p≤0.0074），健康评估量表-残疾指数显著改善（p=0.0037）。重要的是，在第24周，与阿达木单抗相比，更多接受sar治疗的患者达到临床疾病活动指数缓解（7.1% vs 2.7%;标称p=0.0468）和低疾病活动（41.8% vs 24.9%;标称p=0.0005，补充分析）。63.6%（阿达木单抗）和64.1%（sar）的患者发生不良事件，最常见的是中性粒细胞减少和注射部位反应（sar）以及头痛和RA恶化（阿达木单抗）。尽管中性粒细胞减少存在差异，但感染（sar：28.8%;阿达木单抗：27.7%）和严重感染（1.1%，两组）的发生率相似。Sar单药治疗通过改善无法继续MTX治疗的RA患者的体征和症状以及身体功能，证明了优于阿达木单抗单药治疗。两种治疗的安全性特征与预期的类效应一致。NCT02332590。
To compare efficacy and safety of sarilumab monotherapy with adalimumab monotherapy in patients with active rheumatoid arthritis (RA) who should not continue treatment with methotrexate (MTX) due to intolerance or inadequate response. MONARCH was a randomised, active-controlled, double-blind, double-dummy, phase III superiority trial. Patients received sarilumab (200 mg every 2 weeks (q2w)) or adalimumab (40 mg q2w) monotherapy for 24 weeks. The primary end point was change from baseline in 28-joint disease activity score using erythrocyte sedimentation rate (DAS28-ESR) at week 24. Sarilumab was superior to adalimumab in the primary end point of change from baseline in DAS28-ESR (−3.28 vs −2.20; p<0.0001). Sarilumab-treated patients achieved significantly higher American College of Rheumatology 20/50/70 response rates (sarilumab: 71.7%/45.7%/23.4%; adalimumab: 58.4%/29.7%/11.9%; all p≤0.0074) and had significantly greater improvement in Health Assessment Questionnaire-Disability Index (p=0.0037). Importantly, at week 24, more patients receiving sarilumab compared with adalimumab achieved Clinical Disease Activity Index remission (7.1% vs 2.7%; nominal p=0.0468) and low disease activity (41.8% vs 24.9%; nominal p=0.0005, supplemental analysis). Adverse events occurred in 63.6% (adalimumab) and 64.1% (sarilumab) of patients, the most common being neutropenia and injection site reactions (sarilumab) and headache and worsening RA (adalimumab). Incidences of infections (sarilumab: 28.8%; adalimumab: 27.7%) and serious infections (1.1%, both groups) were similar, despite neutropenia differences. Sarilumab monotherapy demonstrated superiority to adalimumab monotherapy by improving the signs and symptoms and physical functions in patients with RA who were unable to continue MTX treatment. The safety profiles of both therapies were consistent with anticipated class effects. NCT02332590.
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作者：
Keystone, EC;Kavanaugh, AF;Chartash, EK
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