Department of Medicine, Section of Rheumatology, Cardiff University School of Medicine, Heath Park, Cardiff CF14 4XN, UK.
Rheumatology (Oxford). 2012 Jul;51(7):1226-34. doi: 10.1093/rheumatology/ker519. Epub 2012 Feb 16.
Certolizumab pegol (CZP) is known to be effective as monotherapy at a dosage of 400 mg every 4 weeks in patients with active RA who have failed DMARDs. The aim of this study was to investigate every 4-week CZP in addition to continued MTX therapy in patients with an inadequate response to MTX alone.
Patients with active RA with inadequate response to MTX, on background MTX, were randomized to double-blind treatment with CZP 400 mg or placebo every 4 weeks for 24 weeks (NCT00544154). The primary efficacy end-point was the ACR 20% improvement criteria (ACR20) response rate at Week 24. Other end-points included ACR50 and ACR70 response rates, ACR core components, 28-joint DAS (ESR) with three variables (DAS28-3) and health-related quality-of-life outcomes in addition to safety.
Of 247 randomized patients, 126 received CZP and 121 received placebo, in addition to MTX. ACR20 response rates were 45.9 vs 22.9%, respectively [P < 0.001 analysed by the Cochran-Mantel-Haenszel (CMH) method], with improvements being apparent from Week 1. Statistically significant improvements over placebo were seen with CZP for ACR50, ACR core components, DAS28-3 and physical functioning. Rates of treatment-related adverse events were similar between groups (25.0 vs 27.7%), and there were no deaths or serious opportunistic infections.
CZP 400 mg every 4 weeks plus MTX demonstrated a favourable risk-benefit profile with rapid onset of action in RA patients with an inadequate response to an earlier MTX therapy.
在对 DMARDs 治疗反应不佳的活动期类风湿关节炎（RA）患者中，培塞利珠单抗（CZP）作为单药治疗，每 4 周给药 400mg 时，具有显著疗效。本研究旨在评估在对甲氨蝶呤（MTX）单药治疗反应不足的患者中，每 4 周给予 CZP 联合 MTX 治疗的疗效。
在 MTX 治疗反应不足的活动期 RA 患者中，在 MTX 背景治疗下，患者随机接受 CZP 400mg 或安慰剂每 4 周一次的双盲治疗，共 24 周（NCT00544154）。主要疗效终点为第 24 周时 ACR20 缓解率。其他终点包括 ACR50 和 ACR70 缓解率、ACR 核心指标、28 关节疾病活动度（DAS）（红细胞沉降率）（ESR）三个变量（DAS28-3）和健康相关生活质量。
在 247 例随机患者中，126 例患者接受 CZP 治疗，121 例患者接受安慰剂治疗，同时接受 MTX 治疗。ACR20 缓解率分别为 45.9%和 22.9%[Cochran-Mantel-Haenszel（CMH）分析，P＜0.001]，从第 1 周开始就有明显改善。与安慰剂相比，CZP 可显著改善 ACR50、ACR 核心指标、DAS28-3 和躯体功能。两组治疗相关不良事件发生率相似（25.0%和 27.7%），无死亡或严重机会性感染。
培塞利珠单抗 400mg 每 4 周一次联合 MTX 治疗，对 MTX 治疗反应不足的 RA 患者具有良好的风险效益比，起效迅速。
