Real-world effectiveness and safety of ofatumumab in relapsing-remitting multiple sclerosis: Insights from naïve and switch patients.

IF 6.9 2区医学 Q1 CLINICAL NEUROLOGY

Neurotherapeutics Pub Date : 2025-09-15 DOI:10.1016/j.neurot.2025.e00724

Clara G Chisari, Salvatore Lo Fermo, Salvatore Iacono, Giuseppe Schirò, Francesca Ruscica, Sabrina Realmuto, Sebastiano Bucello, Paolo Ragonese, Giuseppe Salemi, Francesca Matta, Simona Toscano, Salvatore Cottone, Luigi Maria Edoardo Grimaldi, Francesco Patti

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引用次数: 0

Abstract

Ofatumumab (OFA), a fully human anti-CD20 monoclonal antibody, has shown promising efficacy in treating relapsing multiple sclerosis (RMS) by depleting B cells and reducing disease activity. This real-world, prospective, multicenter study evaluated the effectiveness and safety of OFA in treatment-naïve patients and those transitioning from other disease-modifying therapies (DMTs), including natalizumab (NTZ). RRMS patients initiating OFA at seven MS centers in Sicily and treated for at least 12 months were analyzed. Outcomes included annualized relapse rates (ARR), Expanded Disability Status Scale (EDSS), and the percentage of patients free from relapse, MRI activity, and confirmed EDSS worsening (CEW). Of 213 patients, 66 (30.9 %) were naïve and 147 (69.1 %) were switchers. At 12 months, both groups showed comparable CEW-free (93.9 % vs. 93.8 %), relapse-free (92.4 % vs. 93.2 %), and MRI activity-free (84.8 % vs. 85.0 %) proportions. Within the high-efficacy group, NTZ-switchers showed significantly better MRI outcomes than those switching from other agents, while CEW-free and relapse-free rates remained similar. OFA was well tolerated with no serious adverse events. Predictors of non-response included high baseline MRI activity, disease duration >10 years, and prior NTZ and non-NTZ high-efficacy DMTs. These findings support OFA as a safe and effective option for RRMS across patient subtypes.

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ofatumumab治疗复发缓解型多发性硬化症的有效性和安全性：来自naïve和switch患者的见解。

Ofatumumab （OFA）是一种全人源抗cd20单克隆抗体，通过消耗B细胞和降低疾病活动性，在治疗复发性多发性硬化症（RMS）方面显示出有希望的疗效。这项现实世界、前瞻性、多中心研究评估了OFA在treatment-naïve患者和从其他疾病改善疗法（dmt）（包括natalizumab (NTZ)）过渡的患者中的有效性和安全性。分析了在西西里岛7个MS中心开始OFA治疗且治疗至少12个月的RRMS患者。结果包括年复发率（ARR）、扩展残疾状态量表（EDSS）、无复发患者的百分比、MRI活动和确认的EDSS恶化（CEW）。213例患者中，66例（30.9%）为naïve， 147例（69.1%）为转换患者。12个月时，两组无cew （93.9% vs. 93.8%）、无复发（92.4% vs. 93.2%）和无MRI活动（84.8% vs. 85.0%）的比例相当。在高效组中，ntz转换者的MRI结果明显优于从其他药物转换者，而无cew和无复发率保持相似。OFA耐受性良好，无严重不良事件。无反应的预测因素包括高基线MRI活动，疾病持续时间bb10年，既往NTZ和非NTZ高效dmt。这些发现支持OFA作为跨患者亚型RRMS的安全有效的选择。

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

Neurotherapeutics 医学-神经科学

CiteScore

11.00

自引率

3.50%

发文量

154

审稿时长

6-12 weeks

期刊介绍： Neurotherapeutics® is the journal of the American Society for Experimental Neurotherapeutics (ASENT). Each issue provides critical reviews of an important topic relating to the treatment of neurological disorders written by international authorities. The Journal also publishes original research articles in translational neuroscience including descriptions of cutting edge therapies that cross disciplinary lines and represent important contributions to neurotherapeutics for medical practitioners and other researchers in the field. Neurotherapeutics ® delivers a multidisciplinary perspective on the frontiers of translational neuroscience, provides perspectives on current research and practice, and covers social and ethical as well as scientific issues.