Mount Sinai Hospital, 60 Murray Street, Toronto, ON, Canada.
Rheumatology (Oxford). 2012 Sep;51(9):1628-38. doi: 10.1093/rheumatology/kes082. Epub 2012 May 16.
To evaluate the safety and efficacy of 2-year administration of certolizumab pegol (CZP) + MTX in patients with active RA.
Patients completing 52 weeks in the Rheumatoid Arthritis Prevention of Structural Damage (RAPID) 1 trial (52-week completers), or withdrawing at week 16 due to lack of ACR20 response were eligible for open-label treatment (CZP 400 mg every other week + MTX). After 2 years' treatment, HAQ-Disability Index response, ACR20/50/70 responses, DAS-28 and radiographic progression were assessed in 52-week completers. ACR20/50/70 and DAS-28 were also calculated for the intent-to-treat (ITT) population. Adverse events were assessed in patients who received one or more CZP doses during the study.
At week 100, 88.9% (n = 216) of 52-week completers who originally received CZP 200 mg + MTX and open-label treatment remained in the study. In this group, ACR20/50/70 at week 100 were 68.2, 55.2 and 35.6%, respectively. HAQ-DI and DAS-28 improvements were sustained throughout the open-label extension (mean change -0.79 and -3.5 at week 100, respectively). A total of 46.7% (n = 113) of CZP 200 mg + MTX 52-week completers achieved low disease activity by week 100. Inhibition of radiographic progression was maintained. Similar findings were observed in 52-week completers who originally received CZP 400 mg + MTX and in the ITT population. Rates of serious infection or malignancies did not increase over time and no new safety signals were observed.
CZP + MTX provided sustained, 2-year inhibition of radiographic progression and sustained improvements in RA clinical signs and symptoms, with no new safety signals observed in patients who completed 2 years of treatment.
clinicaltrials.gov, http://www.clinicaltrials.gov, NCT00175877.
评估培塞利珠单抗（CZP）联合甲氨蝶呤（MTX）治疗 2 年对活动性类风湿关节炎（RA）患者的安全性和疗效。
完成类风湿关节炎结构损伤预防（RAPID）1 期试验 52 周（52 周完成者）的患者，或因 ACR20 应答不足而在第 16 周退出的患者，有资格接受开放标签治疗（CZP 400mg 每 2 周 1 次联合 MTX）。在 2 年治疗后，在 52 周完成者中评估了 HAQ 残疾指数应答、ACR20/50/70 应答、DAS-28 和放射影像学进展。ACR20/50/70 和 DAS-28 也在意向治疗（ITT）人群中进行了计算。在研究期间接受过 1 次或多次 CZP 剂量的患者中评估了不良事件。
在最初接受 CZP 200mg+MTX 和开放标签治疗的 52 周完成者中，有 88.9%（n=216）在第 100 周仍在研究中。在该组中，第 100 周时 ACR20/50/70 分别为 68.2%、55.2%和 35.6%。在开放标签延伸期间，HAQ-DI 和 DAS-28 改善得以持续（第 100 周时平均变化分别为-0.79 和-3.5）。共有 46.7%（n=113）的 CZP 200mg+MTX 52 周完成者在第 100 周达到低疾病活动度。放射影像学进展抑制得以维持。在最初接受 CZP 400mg+MTX 和 ITT 人群的 52 周完成者中也观察到了类似的发现。严重感染或恶性肿瘤的发生率没有随时间增加，也没有观察到新的安全信号。
在完成 2 年治疗的患者中，CZP+MTX 持续 2 年抑制放射影像学进展，并持续改善 RA 的临床症状和体征，未观察到新的安全信号。
clinicaltrials.gov，网址：http://www.clinicaltrials.gov，NCT00175877。
