Efficacy and safety of rituximab given at 1,000 mg on days 1 and 15 compared to the standard regimen to treat adult immune thrombocytopenia

Efficacy and safety of rituximab given at 1,000 mg on days 1 and 15 compared to the standard regimen to treat adult immune thrombocytopenia
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DOI:
10.1002/ajh.23518
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发表时间:
2013-10-01
影响因子:
12.8
通讯作者:
Michel, Marc
Michel, Marc
中科院分区:
医学1区
文献类型:
--
作者:
Mahevas, Matthieu;Ebbo, Mikael;Michel, Marc

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利妥昔单抗 (RTX) 被用于治疗免疫性血小板减少症 (ITP),但目前常用于类风湿性关节炎的治疗方案尚未在 ITP 中进行评估。这项大型法国多中心回顾性研究的目的是比较两种 RTX 方案治疗成人 ITP 的有效性和安全性。比较了两种 (RTX) 方案治疗 ITP 的疗效:标准疗法为每周 375 mg/m(2),持续 4 周,而类风湿性关节炎 (RA) 方案为第 1 天和第 15 天 1,000 mg,用于治疗 ITP。我们纳入了既往患有原发性 ITP 并接受 RTX 治疗的成年患者,而不是接受治疗的原发性 ITP。 (CR) 定义为血小板计数 >100 x 10(9)/L,反应 (R) 为血小板计数 >30 x 10(9)/L,且至少为基线值的两倍。在 107 名患者中,61 名 (57%) 接受标准治疗方案,46 名 (43%) 接受 RA 治疗方案。各组之间 3 个月 (M3) 和 12 个月 (M12) 的基线特征和总体缓解率没有显着差异。在 M12 时,接受标准方案治疗的 22/61 名患者 (36%) 和接受 RA 方案治疗的 23/46 名患者 (50%) 取得了总体缓解 (R + CR)。两组中 M3 处的初始响应模式与 M12 处的后续响应模式相关。在多变量分析中,年龄较小和既往治疗次数较少与 M12 总体缓解的可能性较高相关。两组之间的耐受性良好且具有可比性。 RA 方案是治疗成人 ITP 的标准方案的有效且安全的替代方案。是。 J.赫马托尔。 88:858-861,2013 年。(c) 2013 年 Wiley 期刊公司。
Rituximab (RTX) is used off-label to treat immune thrombocytopenia (ITP) but the regimen now commonly used in rheumatoid arthritis has not been evaluated in ITP. The aim of this large French multicenter retrospective study was to compare the efficacy and safety of two RTX regimens in adult's ITP. The efficacy of two (RTX) regimens: standard therapy of 375 mg/m(2) weekly for 4 weeks vs. a rheumatoid arthritis (RA) regimen of 1,000 mg on days 1 and 15, to treat ITP was compared. We included adults patients with previously primary ITP treated with RTX instead of treated primary ITP. (CR) was defined as a platelet count >100 x 10(9)/L, and a response (R) by a platelet count of >30 x 10(9)/L with a least a doubling of the baseline value. Of the 107 patients included, 61 (57%) received the standard regimen and 46 (43%) the RA regimen. Baseline characteristics and overall response rates at 3 month (M3) and 12 months (M12) were not significantly different between the groups. At M12, 22/61 patients (36%) treated with the standard regimen and 23/46 (50%) with the RA regimen achieved an overall response (R + CR). The initial pattern of response at M3 was associated with a later pattern of response by M12 in both groups. In multivariate analysis, both a younger age and a low number of previous therapies were associated with a higher likelihood of overall response at M12. Tolerance was good and comparable between the two groups. The RA regimen is an effective and safe alternative to the standard regimen to treat adults with ITP. Am. J. Hematol. 88:858-861, 2013. (c) 2013 Wiley Periodicals, Inc.