Hu Shengfei, Liao Ziyu, Wang Rui, Zhang Milan, Zeng Qiuming, Zhao Zhihua, Wang Xi, Zhou Hongyu, Li Wei, Lu Yaxin, Yang Huan, Qiu Wei, Li Rui
Department of Neurology, Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou, 510630, Guangdong Province, China.
Department of Neurology, West China Hospital of Sichuan University, Chengdu, China.
J Neurol. 2025 May 10;272(6):387. doi: 10.1007/s00415-025-13125-w.
We aimed to evaluate the association between rituximab (RTX) treatment duration and relapse risk, and explore clinical outcomes following treatment discontinuation in neuromyelitis optica spectrum disorder (NMOSD).
We retrospectively collected data from rituximab-treated patients (>1-year follow-up after treatment initiation) with NMOSD at five major clinical centers in China between 2016 and 2023. The main outcome measures were changes in relapse risk based on the RTX treatment duration and clinical outcomes following relapse after RTX discontinuation. The Andersen-Gill model was used to analyze treatment duration-relapse risk associations.
In total, 106 rituximab-treated patients were included (40 patients discontinued and 66 continued RTX). Longer RTX treatment significantly reduced relapse risk (hazard ratio [HR]=0.43, P < 0.001). Among 28 patients who discontinued RTX and were followed-up for >1 year after drug withdrawal, 53.6% (15/28) relapsed at a median interval of 14 months. Patients with >2 years of RTX treatment exhibited lower annual relapse rate (ARR) (mean ARR: 0.97 vs. 0.28, P = 0.020) and less severe relapses (mean ΔEDSS score: 1.42 vs. 0.50, P = 0.021) after discontinuation, compared to pre-treatment levels. Only one of four (25%) longer-treated and clinically stable patients (≥2 years of RTX treatment and no relapses ≥2 years before discontinuation) experienced a non-severe relapse by 50 months. Patients aged >55 years in the discontinuation group had the lowest post-discontinuation relapse rate.
RTX treatment duration strongly correlated with reduced relapse risk in NMOSD patients. Relapse risk after RTX discontinuation was lower than that after discontinuing traditional oral immunosuppressants, particularly in patients with longer treatment and clinical stability.
我们旨在评估利妥昔单抗（RTX）治疗时长与复发风险之间的关联，并探讨视神经脊髓炎谱系障碍（NMOSD）患者停药后的临床结局。
我们回顾性收集了2016年至2023年期间在中国五个主要临床中心接受RTX治疗（治疗开始后随访>1年）的NMOSD患者的数据。主要结局指标是基于RTX治疗时长的复发风险变化以及RTX停药后复发后的临床结局。采用安德森-吉尔模型分析治疗时长与复发风险的关联。
共纳入106例接受RTX治疗的患者（40例停药，66例继续使用RTX）。更长的RTX治疗显著降低了复发风险（风险比[HR]=0.43，P<0.001）。在28例停用RTX且停药后随访>1年的患者中，53.6%（15/28）复发，中位复发间隔为14个月。与治疗前水平相比，接受RTX治疗>2年的患者停药后年复发率（ARR）较低（平均ARR：0.97对0.28，P=0.020），复发程度较轻（平均扩展残疾状态量表[EDSS]评分变化：1.42对0.50，P=0.021）。在接受更长时间治疗且临床稳定的患者（RTX治疗≥2年且停药前≥2年无复发）中，四分之一（25%）的患者在50个月时仅发生了一次非严重复发。停药组中年龄>55岁的患者停药后复发率最低。
RTX治疗时长与NMOSD患者复发风险降低密切相关。RTX停药后的复发风险低于停用传统口服免疫抑制剂后的复发风险，尤其是在治疗时间较长且临床稳定的患者中。
