Different Treatment Outcomes of Multiple Sclerosis Patients Receiving Ocrelizumab or Ofatumumab

IF 8.1 1区医学 Q1 CLINICAL NEUROLOGY Annals of Neurology Pub Date : 2024-11-25 DOI:10.1002/ana.27143

Sven G. Meuth MD, PhD, Stephanie Wolff MD, Anna Mück MD, Alice Willison MD, Konstanze Kleinschnitz PhD, Saskia Räuber MD, Marc Pawlitzki MD, Franz Felix Konen MD, Thomas Skripuletz MD, Matthias Grothe MD, Tobias Ruck MD, Hagen B. Huttner MD, PhD, Christoph Kleinschnitz MD, Tobias Bopp PhD, Refik Pul MD, Bruce A. C. Cree MD, Hans-Peter Hartung MD, Kathrin Möllenhoff PhD, Steffen Pfeuffer MD

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Abstract

Objective

B-cell–depletion via CD20 antibodies is a safe and effective treatment for active relapsing multiple sclerosis (RMS). Both ocrelizumab (OCR) and ofatumumab (OFA) have demonstrated efficacy in randomized controlled trials and are approved for treatment of RMS, yet nothing is known on their comparative effectiveness, especially in the real-world setting.

Methods

This prospective cohort study includes patients that were started on either OCR or OFA between September 2021 and December 2023. Patients were followed until June 2024 and recruited at 3 large tertiary centers in Germany (Duesseldorf, Essen, and Giessen). Propensity-score-matching was used to address baseline imbalances among patients. Clinical relapses, presence of new or enlarging MRI lesions and 6-month confirmed disability worsening were evaluated. Non-inferiority of OFA compared to OCR was evaluated through comparison of Kaplan–Meier-estimates.

Results

A total of 1,138 patients were initially enrolled in the cohort. Following patient selection and propensity-score-matching, 544 OCR and 417 OFA patients were included in the final analysis. In our primary analysis, OFA was non-inferior to OCR in terms of relapses, disability progression, and accrual of MRI lesions. Subgroup analyses confirmed findings in previously naïve and platform-treated patients. Potential differences between OFA and OCR were seen in patients switching from S1P receptor modulators or natalizumab.

Conclusion

We here provide comparative data on the effectiveness of OCR and OFA in patients with active RMS. OFA was non-inferior to OCR in the overall cohort. Potential differences observed in patients switching from S1P receptor modulators or natalizumab require further validation. ANN NEUROL 2025;97:583–595

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接受奥克雷珠单抗或奥法妥木单抗治疗的多发性硬化症患者的不同疗效

目的：通过 CD20 抗体消耗 B 细胞是治疗活动性复发性多发性硬化症（RMS）的一种安全有效的方法。奥克雷珠单抗（OCR）和ofatumumab（OFA）在随机对照试验中均显示出疗效，并被批准用于治疗多发性硬化症，但关于这两种药物的疗效比较，尤其是在现实世界中的疗效比较，目前尚无定论：这项前瞻性队列研究包括2021年9月至2023年12月期间开始接受OCR或OFA治疗的患者。患者随访至 2024 年 6 月，在德国 3 家大型三级医疗中心（杜塞尔多夫、埃森和吉森）招募。采用倾向分数匹配法解决患者基线不平衡的问题。对临床复发、出现新的或扩大的磁共振成像病灶以及6个月后证实的残疾恶化情况进行了评估。通过比较 Kaplan-Meier 估计值，评估了 OFA 与 OCR 相比的非劣效性：共有 1138 名患者被纳入初始研究。经过患者筛选和倾向分数匹配，544 名 OCR 患者和 417 名 OFA 患者被纳入最终分析。在我们的主要分析中，就复发、残疾进展和磁共振成像病灶累积而言，OFA的疗效并不优于OCR。亚组分析证实了既往未经治疗和平台治疗患者的研究结果。从S1P受体调节剂或纳他珠单抗转用OFA和OCR的患者可能存在差异：我们在此提供了OCR和OFA对活动性RMS患者疗效的比较数据。在整个队列中，OFA的疗效不劣于OCR。从 S1P 受体调节剂或纳他珠单抗转换而来的患者中观察到的潜在差异需要进一步验证。ann neurol 2024。

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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.

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