Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Siriraj Neuroimmunology Center, Division of Neurology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Ann Clin Transl Neurol. 2024 Oct;11(10):2707-2718. doi: 10.1002/acn3.52186. Epub 2024 Aug 26.
To evaluate the efficacy of rituximab (RTX) in stabilizing disability progression in secondary progressive multiple sclerosis (SPMS).
A systematic review was conducted, encompassing studies from inception to April 2023, utilizing the MEDLINE and EMBASE databases. Inclusion criteria comprised studies with a minimum of 3 SPMS patients receiving intravenous RTX in at least one infusion, with a follow-up duration of at least 6 months. Primary outcome measures included changes in Expanded Disability Status Scale (EDSS) scores. Mean differences in pre- and post-RTX EDSS scores were analyzed using a random-effects model. Meta-regression examined age at RTX initiation, pre-RTX EDSS scores, disease duration, and outcome reported time as variables. Secondary outcomes assessed changes in the annualized relapse rate (ARR).
Thirteen studies, involving 604 SPMS patients, met the inclusion criteria. Following a mean follow-up of 2 years, the mean difference in EDSS scores (ΔEDSS = EDSS - EDSS) was -0.21 (95% CI -0.51 to 0.08, p = 0.16), indicating no significant variation. Multivariable meta-regression identified significant associations between EDSS score mean difference and pre-RTX EDSS scores, disease duration at RTX initiation, and outcome reported time. However, age at RTX initiation showed no significant association. Pre- and post-RTX ARR data were available for 245 out of 604 SPMS patients across seven studies, revealing a mean difference in ARR (ΔARR = ARR - ARR) of 0.74 (95% CI 0.19-1.29, p = 0.008).
RTX demonstrates efficacy in reducing relapse frequency and exhibits potential in stabilizing disability progression over a 2-year follow-up, particularly among individuals with shorter disease duration.
评估利妥昔单抗（RTX）在稳定继发进展型多发性硬化症（SPMS）患者残疾进展中的疗效。
进行了系统评价，检索了从建库至 2023 年 4 月的 MEDLINE 和 EMBASE 数据库，纳入至少有 3 例 SPMS 患者接受至少 1 次静脉输注 RTX，随访时间至少 6 个月的研究。主要结局指标为扩展残疾状况量表（EDSS）评分变化。采用随机效应模型分析 RTX 前后 EDSS 评分的平均差异。采用元回归分析 RTX 起始年龄、RTX 前 EDSS 评分、疾病病程和报告结局时间等变量。次要结局评估年复发率（ARR）的变化。
符合纳入标准的 13 项研究共纳入 604 例 SPMS 患者。在平均 2 年的随访后，EDSS 评分的平均差异（ΔEDSS=EDSS-EDSS）为-0.21（95%CI-0.51 至 0.08，p=0.16），表明无显著差异。多变量元回归分析发现 EDSS 评分平均差异与 RTX 起始时的 EDSS 评分、疾病病程和报告结局时间有关，而 RTX 起始年龄与 EDSS 评分平均差异无关。245 例 SPMS 患者（7 项研究）有 RTX 前后的 ARR 数据，ARR 的平均差异（ΔARR=ARR-ARR）为 0.74（95%CI0.19 至 1.29，p=0.008）。
RTX 可降低复发频率，在 2 年随访中具有稳定残疾进展的潜力，尤其是在疾病病程较短的患者中。
