Comparative Safety Profiles of Ocrelizumab and Rituximab in Multiple Sclerosis Treatment Using Real-World Evidence.

IF 7.7 1区医学 Q1 CLINICAL NEUROLOGY

Annals of Neurology Pub Date : 2025-09-08 DOI:10.1002/ana.78033

Gabriel Cerono, Bruce A C Cree, Stephen L Hauser, Sergio E Baranzini

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引用次数: 0

Abstract

Objective: The objective of this study was to compare the long-term safety profiles of ocrelizumab and rituximab in persons with multiple sclerosis (MS).

Methods: Using retrospective data from the University of California (UC) Health System, we simulated a target clinical trial. The primary cohort from UC San Francisco (UCSF) and a validation cohort from 5 other UC Medical Centers were analyzed. After applying exclusion criteria and propensity score matching based on disease characteristics, demographics, and socioeconomic factors, we compared UCSF patients receiving ocrelizumab (n = 542) and rituximab (n = 271)and validated in the UC-wide MS population (n = 486 and n = 162 patients, respectively). The primary outcome was an all-cause hospitalization rate; secondary outcomes included hypogammaglobulinemia development and infection incidence.

Results: Rituximab showed higher all-cause hospitalization rates compared to ocrelizumab in both UCSF (incidence rate ratio [IRR] = 2.29, 95% confidence interval [CI] = 1.37-3.82, p = 0.001) and UC-wide cohorts (IRR = 4.54, 95% CI = 4.30-7.61, p < 0.001). Cumulative hazard ratios (HRs) were similarly elevated with rituximab at UCSF (HR = 2.27, 95% CI = 1.37-3.75, p = 0.001) and UC-wide (HR = 4.01, 95% CI = 2.25-6.32, p < 0.001). The risk of developing hypogammaglobulinemia was higher with rituximab at both UCSF (HR = 2.72, 95% CI = 1.18-6.29, p = 0.003) and UC-wide (HR = 4.79, 95% CI = 2.04-11.25, p < 0.001).

Interpretation: A more favorable safety profile was observed for ocrelizumab, with lower rates of hospitalization and hypogammaglobulinemia across 2 independent cohorts. These findings may help guide treatment strategies in persons with MS. ANN NEUROL 2025.

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Ocrelizumab和Rituximab在多发性硬化症治疗中的安全性比较

目的：本研究的目的是比较ocrelizumab和rituximab在多发性硬化症（MS）患者中的长期安全性。方法：利用加利福尼亚大学（UC）卫生系统的回顾性数据，我们模拟了一项目标临床试验。对来自加州大学旧金山分校（UCSF）的主要队列和来自其他5个加州大学医学中心的验证队列进行分析。在应用基于疾病特征、人口统计学和社会经济因素的排除标准和倾向评分匹配后，我们比较了接受ocrelizumab （n = 542）和利妥昔单抗（n = 271）的UCSF患者，并在uc范围内的MS人群中进行了验证（分别为n = 486和n = 162）。主要结局是全因住院率；次要结局包括低丙种球蛋白血症的发展和感染发生率。结果：利妥昔单抗在UCSF（发病率比[IRR] = 2.29, 95%可信区间[CI] = 1.37-3.82, p = 0.001）和uc全队列（IRR = 4.54, 95% CI = 4.30-7.61, p）中均显示出比奥克雷珠单抗更高的全因住院率。解释：在2个独立队列中，观察到奥克雷珠单抗更有利的安全性，住院率和低γ球蛋白血症率更低。这些发现可能有助于指导MS. ANN NEUROL 2025患者的治疗策略。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of Neurology 医学-临床神经学

CiteScore

18.00

自引率

1.80%

发文量

270

审稿时长

3-8 weeks

期刊介绍： Annals of Neurology publishes original articles with potential for high impact in understanding the pathogenesis, clinical and laboratory features, diagnosis, treatment, outcomes and science underlying diseases of the human nervous system. Articles should ideally be of broad interest to the academic neurological community rather than solely to subspecialists in a particular field. Studies involving experimental model system, including those in cell and organ cultures and animals, of direct translational relevance to the understanding of neurological disease are also encouraged.