Zhang Chengyi, Liu Rui, Gao Bin, Li Ting, Wang Huabing, Song Tian, Ma Yuetao, Xu Wangshu, Liu Yun, Zhang Xinghu, Tian De-Cai, Yang Chunsheng, Shi Kaibin
Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China.
J Neuroimmunol. 2024 Feb 15;387:578285. doi: 10.1016/j.jneuroim.2024.578285. Epub 2024 Jan 8.
Rituximab effectively targets B cells and reduces relapses in neuromyelitis optica spectrum disorder (NMOSD). But the ideal dosage and treatment intervals remain unanswered. We aimed to assess the efficacy and safety of low and ultralow-dose rituximab in NMOSD.
We conducted a retrospective analysis of NMOSD patients treated with rituximab at two Chinese tertiary hospitals. Patients received either a low-dose regimen (500 mg reinfusion every 6 months) or an ultralow-dose regimen: 100 to 300 mg rituximab based on CD19B cells (100 mg for 1-1.5% of peripheral blood mononuclear cells, 200 mg for 1.5-5%, and 300 mg for over 5%).
We analyzed data from 136 patients (41 in the low-dose group, 95 in the ultralow-dose group) with median follow-up durations of 43 and 34.2 months, respectively. Both groups exhibited similar sex distribution, age at disease onset, annual relapse rate, and baseline disease duration. Survival analysis showed that ultralow-dose rituximab was noninferior to low-dose rituximab in preventing relapses. Infusion reactions occurred in 20 of 173 (11.6%) low-dose treatments and 9 of 533 (1.7%) ultralow-dose treatments. B-cell re-emergence was observed in 137 of 236 (58.1%) monitors in the low-dose group and 367 of 1136 (32.3%) monitors in the ultralow-dose group.
Ultralow dose rituximab was noninferior to low-dose rituximab in preventing NMOSD relapses. A randomized controlled trial is essential to validate these findings.
利妥昔单抗可有效靶向B细胞并减少视神经脊髓炎谱系障碍（NMOSD）的复发。但理想的剂量和治疗间隔仍未明确。我们旨在评估低剂量和超低剂量利妥昔单抗治疗NMOSD的疗效和安全性。
我们对两家中国三级医院接受利妥昔单抗治疗的NMOSD患者进行了回顾性分析。患者接受低剂量方案（每6个月重复输注500mg）或超低剂量方案：根据CD19+B细胞数量给予100至300mg利妥昔单抗（外周血单个核细胞的1%-1.5%给予100mg，1.5%-5%给予200mg，超过5%给予300mg）。
我们分析了136例患者的数据（低剂量组41例，超低剂量组95例），中位随访时间分别为43个月和34.2个月。两组的性别分布、发病年龄、年复发率和基线病程相似。生存分析表明，超低剂量利妥昔单抗在预防复发方面不劣于低剂量利妥昔单抗。低剂量治疗的173次中有20次（11.6%）发生输注反应，超低剂量治疗的533次中有9次（1.7%）发生输注反应。低剂量组236次监测中有137次（58.1%）观察到B细胞重新出现，超低剂量组1136次监测中有367次（32.3%）观察到B细胞重新出现。
超低剂量利妥昔单抗在预防NMOSD复发方面不劣于低剂量利妥昔单抗。有必要进行一项随机对照试验来验证这些发现。
