与单用改善病情抗风湿药（DMARD）治疗相比，依那西普联合DMARD治疗对拉丁美洲活动性类风湿关节炎患者维持低疾病活动度和缓解的作用：一项随机试验的亚组分析
Maintenance of low disease activity and remission with etanercept-disease-modifying antirheumatic drug (DMARD) combination therapy compared with treatment with DMARDs alone in Latin American patients with active rheumatoid arthritis: Subset analysis of a randomized trial.
作者信息
Zerbini Cristiano A F, Abud-Mendoza Carlos, Mendez-Patarroyo Paul, De Angelo Andrade Mauricio, Pedersen Ron, Vlahos Bonnie, Borlenghi Cecilia Elena
机构信息
Centro Paulista de Investigação Clínica, São Paulo, Brazil Hospital Central and Faculty of Medicine, Universidad Autónoma de San Luis Potosí, San Luis, Mexico Universidad de los Andes and Hospital Universitario Fundación Santafe de Bogotá, Bogotá, Colombia Pfizer, São Paulo, Brazil Pfizer, Collegeville, Pennsylvania, USA Pfizer, Buenos Aires, Argentina.
出版信息
Medicine (Baltimore). 2018 Sep;97(36):e11989. doi: 10.1097/MD.0000000000011989.
BACKGROUND
Current guidelines on the treatment of rheumatoid arthritis (RA) recommend early therapy targeting the achievement of low disease activity (LDA) or clinical remission. Little published information is available on the success of this treatment strategy in Latin America. In a subset analysis of patients from Latin America, we compared efficacy maintenance with etanercept 50 mg once weekly (ETN50) versus placebo (PBO), on a background of methotrexate (MTX) ± other non-biologic, disease-modifying antirheumatic drugs, in patients with moderate-to-severe RA who had achieved LDA with ETN50.
METHODS
In the Treat-to-Target trial, adult patients with active RA nonresponsive to MTX were treated with ETN50 for 24 weeks (Period 1). Patients achieving LDA were randomized to receive ETN50 or PBO for 28 additional weeks (Period 2). The proportion of patients maintaining LDA at week 52 and other efficacy and quality-of-life measures were assessed. Descriptive statistics are presented using last observation carried forward imputation of data.
RESULTS
Of the 64 patients from Latin America treated in Period 1, 61 (95.3%) achieved LDA. Among patients receiving ETN50, 13/34 remained in LDA and 6/14 maintained remission at week 52 versus 6/27 and 4/10 patients receiving PBO. The median time to flare was 113 days and 33 days for the ETN50 and PBO groups, respectively. In the overall population, adverse events were reported in 37% and 43%, serious adverse events in 1% and 4%, and serious infections in 0% and 2% of patients in the ETN50 and PBO groups, respectively.
CONCLUSIONS
In patients with RA from Latin America, continuing treatment with ETN50 after achieving LDA appears to result in a higher proportion of patients maintaining LDA and remission compared with switching to PBO. CLINICALTRIALS.
GOV REGISTRATION
NCT01578850.
背景
目前类风湿关节炎（RA）的治疗指南推荐早期治疗以实现低疾病活动度（LDA）或临床缓解为目标。关于这种治疗策略在拉丁美洲的成功情况，公开信息较少。在一项对拉丁美洲患者的亚组分析中，我们比较了在甲氨蝶呤（MTX）±其他非生物类改善病情抗风湿药物背景下，中度至重度RA患者在使用依那西普50mg每周一次（ETN50）实现LDA后，继续使用ETN50与使用安慰剂（PBO）维持疗效的情况。
方法
在达标治疗试验中，对MTX治疗无效的活动性RA成年患者使用ETN50治疗24周（第1阶段）。达到LDA的患者被随机分配接受ETN50或PBO再治疗28周（第2阶段）。评估了第52周时维持LDA的患者比例以及其他疗效和生活质量指标。使用末次观察结转法对数据进行描述性统计。
结果
在第1阶段接受治疗的64名拉丁美洲患者中，61名（95.3%）达到LDA。在接受ETN50的患者中，第52周时13/34维持LDA，6/14维持缓解，而接受PBO的患者分别为6/27和4/10。ETN50组和PBO组的中位复发时间分别为113天和33天。在总体人群中，ETN50组和PBO组分别有37%和43%的患者报告了不良事件，1%和4%的患者报告了严重不良事件，0%和2%的患者报告了严重感染。
结论
在拉丁美洲的RA患者中，与换用PBO相比，在达到LDA后继续使用ETN50治疗似乎能使更多患者维持LDA和缓解。临床试验。
政府注册编号
NCT01578850。
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