Non-TNF-Targeted Biologic vs a Second Anti-TNF Drug to Treat Rheumatoid Arthritis in Patients With Insufficient Response to a First Anti-TNF Drug A Randomized Clinical Trial
Non-TNF-Targeted Biologic vs a Second Anti-TNF Drug to Treat Rheumatoid Arthritis in Patients With Insufficient Response to a First Anti-TNF Drug A Randomized Clinical Trial
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DOI：
10.1001/jama.2016.13512
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发表时间：
2016-09-20
影响因子：
120.7
通讯作者：
Ravaud, Philippe
中科院分区：
文献类型：
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作者：
Gottenberg, Jacques-Eric;Brocq, Olivier;Ravaud, Philippe
三分之一的类风湿关节炎患者对肿瘤坏死因子α反应不足（TNF-α）抑制剂;对选择下一种治疗方法的指导很少。目的比较非TNF靶向生物制剂（非TNF）与第二种抗TNF药物对TNF抑制剂反应不足的患者的疗效。设计，设置，共300名患者（2009-2012年期间进行）患有类风湿性关节炎，具有持续性疾病活动（28个关节的疾病活动性评分-红细胞沉降率[DAS 28-ESR] >= 3.2 [范围，0-9.3]）和对抗TNF治疗反应不足的患者纳入一项为期52周的多中心、实用、开放标签随机临床试验。最终随访日期为2013年8月。干预患者被随机分配（1：1）接受非TNF靶向生物制剂或与既往治疗不同的抗TNF。每个随机分组内的生物处方的选择留给治疗clinics.Main结局和措施的主要结局是良好或中度反应的患者的比例，根据欧洲反风湿联盟（EULAR）规模在第24周。次要结局包括第12周和第52周的EULAR应答;第12周、第24周和第52周的EULAR应答; DAS 28 ESR，低疾病活动度（DAS 28
IMPORTANCE One-third of patients with rheumatoid arthritis show inadequate response to tumor necrosis factor alpha (TNF-alpha) inhibitors; little guidance on choosing the next treatment exists.OBJECTIVE To compare the efficacy of a non-TNF-targeted biologic (non-TNF) vs a second anti-TNF drug for patients with insufficient response to a TNF inhibitor.DESIGN, SETTING, AND PARTICIPANTS A total of 300 patients (conducted between 2009-2012) with rheumatoid arthritis, with persistent disease activity (disease activity score in 28 joints-erythrocyte sedimentation rate [DAS28-ESR] >= 3.2 [range, 0-9.3]) and an insufficient response to anti-TNF therapy were included in a 52-week multicenter, pragmatic, open-label randomized clinical trial. The final follow-up date was in August 2013.INTERVENTIONS Patients were randomly assigned (1: 1) to receive a non-TNF-targeted biologic agent or an anti-TNF that differed from their previous treatment. The choice of the biologic prescribed within each randomized group was left to the treating clinician.MAIN OUTCOMES AND MEASURES The primary outcome was the proportion of patients with good or moderate response according to the European League Against Rheumatism (EULAR) scale at week 24. Secondary outcomes included the EULAR response at weeks 12 and 52; at weeks 12, 24, and 52; DAS28ESR, low disease activity (DAS28