Division of Rheumatology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Anam-dong 5-ga, Seongbuk-gu, Seoul 136-705, Korea.
Rheumatol Int. 2011 Nov;31(11):1493-9. doi: 10.1007/s00296-010-1526-y. Epub 2010 May 16.
The aims of this study were to assess the efficacy and safety of rituximab in patients with active rheumatoid arthritis (RA). The authors surveyed randomized controlled trials (RCTs) that examined the efficacy of rituximab in disease modifying anti-rheumatic drug (DMARD) (including methotrexate [MTX]) or tumor necrosis factor (TNF)-blocker-resistant or intolerant patients with active RA using Medline, the Cochrane Controlled Trials Register, and manual searches. Meta-analysis of RCTs was performed to determine the treatment efficacy and safety outcomes of rituximab (1 course, consisting of two infusions of 1,000 mg each) concomitant with MTX. The three RCTs included 938 DMARD or TNF-blocker-resistant or intolerant RA patients. Follow-up periods ranged from 24 to 48 weeks. American College of Rheumatology response (ACR) 20, ACR50, and ACR70 response rates were significantly higher for the rituximab plus MTX than for placebo controls (primary efficacy outcome, ACR50; risk ratio [RR] 3.648, 95% confidence interval [CI] 2.478-5.369, P < 0.001). For those treated with rituximab, the incidence adverse events of all systems were not higher than in those treated with placebo (RR 1.062, 95% CI 0.912-1.236, P = 0.438). With respect to the number of patients that experienced at least one serious adverse event, no significant difference was observed between patients treated with rituximab and placebo (RR 0.855, 95% CI 0.622-1.174, P = 0.333). A single course of rituximab with concomitant MTX therapy was found to be effective in DMARD or TNF-blocker-resistant or intolerant patients with active RA.
本研究旨在评估利妥昔单抗治疗活动期类风湿关节炎（RA）患者的疗效和安全性。作者检索了 Medline、Cochrane 对照试验注册库和手工检索，以评估利妥昔单抗治疗疾病修饰抗风湿药物（DMARD）（包括甲氨蝶呤[MTX]）或肿瘤坏死因子（TNF）-阻滞剂耐药或不耐受的活动期 RA 患者的疗效。对 RCT 进行荟萃分析，以确定利妥昔单抗（1 个疗程，包括 2 次各 1000mg 的输注）联合 MTX 的治疗效果和安全性结局。这 3 项 RCT 共纳入 938 例 DMARD 或 TNF-阻滞剂耐药或不耐受的 RA 患者。随访时间为 24 至 48 周。利妥昔单抗联合 MTX 组的美国风湿病学会（ACR）20、50 和 70 缓解率显著高于安慰剂对照组（主要疗效结局，ACR50；风险比[RR]3.648，95%置信区间[CI]2.478-5.369，P<0.001）。接受利妥昔单抗治疗的患者的所有系统不良反应发生率并不高于接受安慰剂治疗的患者（RR 1.062，95%CI 0.912-1.236，P=0.438）。对于至少发生 1 例严重不良事件的患者人数，接受利妥昔单抗和安慰剂治疗的患者之间未观察到显著差异（RR 0.855，95%CI 0.622-1.174，P=0.333）。在 DMARD 或 TNF-阻滞剂耐药或不耐受的活动期 RA 患者中，发现利妥昔单抗联合 MTX 治疗 1 个疗程是有效的。
