Seattle Rheumatology Associates, Swedish Medical Center, Seattle, WA 98104, USA.
J Rheumatol. 2010 May;37(5):917-27. doi: 10.3899/jrheum.090442. Epub 2010 Mar 1.
To assess the efficacy and safety of 1 versus 2 courses of rituximab over 48 weeks in patients with rheumatoid arthritis (RA).
Adult patients taking methotrexate with a previous inadequate response to > or = 1 tumor necrosis factor inhibitor received 1 course of open-label rituximab (2 x 1000 mg IV) at baseline. From Week 24, patients were randomized to receive an additional course of retreatment with rituximab or placebo. Efficacy responses at Week 48 relative to baseline were assessed.
Of 559 patients who received the open-label first course of rituximab, 475 patients were randomized to a second course (rituximab retreatment: n = 318, placebo retreatment: n = 157). Relative to baseline, patients who took rituximab during retreatment had significantly improved efficacy at Week 48 compared to patients who took a placebo during retreatment [American College of Rheumatology (ACR20) criteria, 54% vs 45%, p = 0.02; change in Disease Activity Score-28 mean -1.9 vs -1.5, p = 0.006]. Differences in efficacy between groups were first observed following Weeks 28-32. Worsening of most components of the ACR core set occurred in the placebo-retreated patients with relative maintenance of these measures in rituximab-retreated patients. Randomized patients who had achieved week 24 ACR responses following the first course had greater odds of losing response if retreated with placebo (odds ratios for ACR20, ACR50, ACR70: 2.09, 2.03, and 4.09, respectively). Following retreatment, the proportion of patients experiencing any adverse events (AE), serious AE, infections, and serious infections were comparable between the rituximab and placebo retreatment groups.
Two courses of rituximab about 6 months apart resulted in improved and sustained efficacy at 1 year, compared with 1 course, with a similar safety profile.
评估在类风湿关节炎（RA）患者中，48 周内接受 1 个疗程或 2 个疗程利妥昔单抗治疗的疗效和安全性。
正在接受甲氨蝶呤治疗且先前对 >或= 1 种肿瘤坏死因子抑制剂反应不足的成年患者，在基线时接受 1 个疗程的开放性利妥昔单抗（2×1000mg IV）治疗。从第 24 周开始，患者被随机分配接受额外的利妥昔单抗或安慰剂再治疗。在第 48 周时评估相对于基线的疗效反应。
在接受开放性第 1 个疗程利妥昔单抗治疗的 559 例患者中，有 475 例患者被随机分配至第 2 个疗程（利妥昔单抗再治疗：n=318，安慰剂再治疗：n=157）。与基线相比，在再治疗时接受利妥昔单抗治疗的患者在第 48 周时的疗效明显优于在再治疗时接受安慰剂治疗的患者[美国风湿病学会（ACR）20 标准，54%比 45%，p=0.02；疾病活动评分-28 的均值变化-1.9 比-1.5，p=0.006]。两组之间的疗效差异在第 28-32 周时首次观察到。在接受安慰剂再治疗的患者中，大多数 ACR 核心指标的恶化情况加重，而在接受利妥昔单抗再治疗的患者中，这些指标相对维持。在第 1 个疗程后已达到第 24 周 ACR 反应的随机患者，如果用安慰剂再治疗，其失去反应的可能性更大（ACR20、ACR50、ACR70 的比值比分别为 2.09、2.03 和 4.09）。再治疗后，利妥昔单抗再治疗组和安慰剂再治疗组的任何不良事件（AE）、严重 AE、感染和严重感染的发生率相似。
与 1 个疗程相比，6 个月间隔的 2 个疗程利妥昔单抗治疗在 1 年时可改善并维持疗效，且安全性相似。
