Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study.
Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study.
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DOI：
10.1136/ard.2008.099291
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发表时间：
2009-06
影响因子：
27.4
通讯作者：
Strand V
中科院分区：
文献类型：
--
作者：
Fleischmann R;Vencovsky J;van Vollenhoven RF;Borenstein D;Box J;Coteur G;Goel N;Brezinschek HP;Innes A;Strand V
肿瘤坏死因子α (TNFα)是一种参与类风湿关节炎（RA）发病的促炎细胞因子。TNFα抑制剂治疗可降低RA患者的疾病活动性并改善预后。该研究评估了certolizumab pegol 400mg作为活动性RA患者单药治疗的有效性和安全性，certolizumab pegol是一种新型聚乙二醇（PEG）酰化的无fc TNFα抑制剂。在这项为期24周的多中心，随机，双盲，安慰剂对照研究中，220名先前未能使用小于或等于1的疾病改善抗风湿药物（DMARD）的患者被1:1随机分配，每4周接受皮下certolizumab pegol 400 mg （n = 111）或安慰剂（n = 109）。根据美国风湿病学会标准（ACR20），主要终点是在第24周改善20%。次要终点包括ACR50/70反应、ACR成分评分、28关节疾病活动评分、红细胞沉降率3 （DAS28(ESR)3）、患者报告的结局（包括身体功能、健康相关生活质量（HRQoL）、疼痛和疲劳）和安全性。在第24周，certolizumab pegol 400mg / 4周组的ACR20缓解率为45.5%，而安慰剂组为9.3% （p<0.001）。certolizumab pegol与安慰剂在ACR20应答方面的差异早在第1周至第24周就有统计学意义（p<0.001）。在certolizumab pegol早期也观察到ACR50、ACR组分、DAS28(ESR)3和所有患者报告的结果的显著改善，并在整个研究中持续。大多数不良事件为轻度或中度，未报告死亡或结核病病例。与安慰剂相比，每4周使用certolizumab pegol 400 mg单药治疗有效地减少了先前失败大于或等于1 DMARD的患者的活动性RA的体征和症状，并证明了可接受的安全性。NCT00548834。
Tumour necrosis factor α (TNFα) is a proinflammatory cytokine involved in the pathogenesis of rheumatoid arthritis (RA). Treatment with TNFα inhibitors reduces disease activity and improves outcomes for patients with RA. This study evaluated the efficacy and safety of certolizumab pegol 400 mg, a novel, poly-(ethylene glycol) (PEG)ylated, Fc-free TNFα inhibitor, as monotherapy in patients with active RA. In this 24-week, multicentre, randomised, double-blind, placebo-controlled study, 220 patients previously failing ⩾1 disease-modifying antirheumatic drug (DMARD) were randomised 1:1 to receive subcutaneous certolizumab pegol 400 mg (n = 111) or placebo (n = 109) every 4 weeks. The primary endpoint was 20% improvement according to the American College of Rheumatology criteria (ACR20) at week 24. Secondary endpoints included ACR50/70 response, ACR component scores, 28-joint Disease Activity Score Erythrocyte Sedimentation Rate 3 (DAS28(ESR)3), patient-reported outcomes (including physical function, health-related quality of life (HRQoL), pain and fatigue) and safety. At week 24, the ACR20 response rates were 45.5% for certolizumab pegol 400 mg every 4 weeks vs 9.3% for placebo (p<0.001). Differences for certolizumab pegol vs placebo in the ACR20 response were statistically significant as early as week 1 through to week 24 (p<0.001). Significant improvements in ACR50, ACR components, DAS28(ESR)3 and all patient-reported outcomes were also observed early with certolizumab pegol and were sustained throughout the study. Most adverse events were mild or moderate and no deaths or cases of tuberculosis were reported. Treatment with certolizumab pegol 400 mg monotherapy every 4 weeks effectively reduced the signs and symptoms of active RA in patients previously failing ⩾1 DMARD compared with placebo, and demonstrated an acceptable safety profile. NCT00548834.
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