Efficacy of different rituximab therapeutic strategies in patients with neuromyelitis optica spectrum disorders
Efficacy of different rituximab therapeutic strategies in patients with neuromyelitis optica spectrum disorders
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DOI：
10.1016/j.msard.2019.101430
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发表时间：
2019-11-01
影响因子：
4
通讯作者：
Gobbi, Claudio
中科院分区：
文献类型：
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作者：
Novi, Giovanni;Bovis, Francesca;Gobbi, Claudio
目的：在NMOSD患者的多中心真实数据集中，根据利妥昔单抗(RTX)诱导和维持方案评估疾病活动性。方法：这是一项包括21个意大利中心和1个瑞士中心使用RTX治疗的NMOSD患者的观察性-回溯性多中心研究。根据诱导策略(IND-A，每周输注375 mg/m2，间隔15天(IND-A)，持续1个月)和维持治疗(A方案(M-A)和B方案(M-B)，根据CD19+B细胞(M-B1)或CD27+记忆B细胞(M-B2)监测进一步细分)，总结人口统计学、复发率和随访期间的不良事件。结果：131名受试者中，127名患者完成了诱导方案，119名患者至少进行了一次随访，并进入了结果分析。中位随访期为1.7年(0.1~11.6)。RTX开始前一年的年化复发率(ARR)为1.7，随访时降至0.19。ARR和首次复发时间(RAR)分析显示，IND-B和M-A的疾病活动性有增加的趋势。在随访期间，MT-B2患者均未复发。在多变量分析中，在RTX开始前一年内接受过治疗的复发次数与较高的ARR和较低的TTFR显著相关。解释：我们确认RTX在NMOSD患者中的疗效。为了促进RTX疗效并降低成本和副作用，有必要使用特定的诱导和维护方案。
Objective: To evaluate disease activity according to rituximab (RTX) induction and maintenance regimens in a multicenter real-life dataset of NMOSD patients.Methods: This is an observational-retrospective multicentre study including patients with NMOSD treated with RTX in 21 Italian and 1 Swiss centers. Demographics, relapse rate and adverse events over the follow-up were summarized taking into account induction strategy (two-1 g infusions at a 15-day interval (IND-A) vs. 375 mg/m2/week infusions for one month (IND-B)) and maintenance therapy (regimen A (M-A) with fixed time-points infusions vs. regimen B (M-B) based on cytofluorimetric driven reinfusion regimens, the least further subdivided according to CD19 + B cells (M-B1) or CD27 + memory B cells (M-B2) monitoring).Results: 131 subjects were enrolled, 127 patients completed the induction regimen and 119 patients had at least one follow-up visit and were included in the outcome analysis. Median follow-up was 1.7 years (range 0.1-11.6). Annualized relapse rate (ARR) was 1.7 in the year before RTX start and decreased to 0.19 during the follow-up. Both ARR and Time to first relapse ( raR) analysis showed a trend toward an increased disease activity for IND-B and M-A. No patients with MT-B2 experienced relapses during the follow-up. Number of relapses in the year before RTX initiation and having received a previous treatment were significantly associated with higher ARR and reduced TTFR in the multivariate analysis.Interpretation: We confirm RTX efficacy in NMOSD patients. Use of specific induction and maintenance protocols is warranted in order to foster RTX efficacy and to reduce costs and side effects.