Ofatumumab for treating autoimmune nodopathy

IF 3.9 3区医学 Q1 CLINICAL NEUROLOGY Journal of the Peripheral Nervous System Pub Date : 2025-01-12 DOI:10.1111/jns.12679

Jianian Hu, Yongsheng Zheng, Chong Sun, Jian Sun, Jianying Xi, Sushan Luo, Kai Qiao, Chongbo Zhao, Jie Lin

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Abstract

Background and Aims

To investigate the treatment of ofatumumab in autoimmune nodopathy (AN).

Methods

An open-label, prospective, observational study was conducted in patients with AN. The regimen was 20 mg ofatumumab subcutaneously on day 0, 7, 14, 28, and subsequently every 4 weeks in a total of 24 weeks. The primary endpoint of the study was the proportion of patients with confirmed clinical improvement.

Results

All of the eight patients (100%) improved at Week 24. The median time to improvement was 8 (IQR: 7–10) weeks. The four patients previously treated with rituximab and two with irregular injections of ofatumumab (OFA) improved. At Week 24, the adjusted INCAT score, MRC sum score, cI-RODS, and grip strength in nondominant hand significantly improved from baseline. In nerve conduction studies, all of the six patients with available data (100%) improved. The median sNfL significantly reduced from baseline at Week 8. Anti-paranodal antibody in seven patients with anti-NF155 antibodies reduced from baseline at Week 20. In seven of the eight patients, CD19+ B cells were significantly reduced at Week 4. No serious adverse events were reported.

Interpretation

The regimen was 20 mg ofatumumab subcutaneously on day 0, 7, 14, 28, and every 4 weeks from Week 4, in a total of 24 weeks. The ofatumumab therapy may provide a more convenient and safer treatment for patients with AN, while serving as an effective alternative for those who did not respond to rituximab.

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Ofatumumab用于治疗自身免疫性肿瘤病。

背景和目的研究自身免疫性结节病（AN）患者使用伊妥单抗的治疗方法：在AN患者中开展了一项开放标签、前瞻性、观察性研究。治疗方案为在第0、7、14、28天皮下注射20毫克的ofatumumab，随后每4周一次，共24周。研究的主要终点是证实临床症状得到改善的患者比例：8名患者（100%）均在第24周时病情有所好转。病情好转的中位时间为 8 周（IQR：7-10 周）。之前接受过利妥昔单抗治疗的四名患者和不规则注射 OFatumumab (OFA) 的两名患者病情均有改善。第24周时，调整后的INCAT评分、MRC总分、cI-RODS和非支配手握力与基线相比均有显著改善。在神经传导研究中，有数据可查的六名患者（100%）的病情均有所改善。第 8 周时，sNfL 中位数较基线明显降低。7名患者的抗NF155抗体在第20周时比基线降低。8名患者中有7名患者的CD19+ B细胞在第4周时明显减少。无严重不良事件报告：治疗方案为第0、7、14、28天皮下注射20毫克ofatumumab，从第4周开始每4周一次，共24周。ofatumumab疗法可为AN患者提供更方便、更安全的治疗，同时也可作为利妥昔单抗无效患者的有效替代疗法。

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

Journal of the Peripheral Nervous System 医学-临床神经学

CiteScore

6.10

自引率

7.90%

发文量

审稿时长

>12 weeks

期刊介绍： The Journal of the Peripheral Nervous System is the official journal of the Peripheral Nerve Society. Founded in 1996, it is the scientific journal of choice for clinicians, clinical scientists and basic neuroscientists interested in all aspects of biology and clinical research of peripheral nervous system disorders. The Journal of the Peripheral Nervous System is a peer-reviewed journal that publishes high quality articles on cell and molecular biology, genomics, neuropathic pain, clinical research, trials, and unique case reports on inherited and acquired peripheral neuropathies. Original articles are organized according to the topic in one of four specific areas: Mechanisms of Disease, Genetics, Clinical Research, and Clinical Trials. The journal also publishes regular review papers on hot topics and Special Issues on basic, clinical, or assembled research in the field of peripheral nervous system disorders. Authors interested in contributing a review-type article or a Special Issue should contact the Editorial Office to discuss the scope of the proposed article with the Editor-in-Chief.