多发性硬化症患者妊娠期持续接触奥法妥木单抗的影响

IF 2.3 Q3 CLINICAL NEUROLOGY Neurology. Clinical practice Pub Date : 2025-02-01 Epub Date: 2024-11-07 DOI:10.1212/CPJ.0000000000200410
Simon Hefner, Tiago Lerda Casaccia, Edda Hofstaetter, Ferdinand Otto, Kerstin Hellwig, Tobias Moser
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引用次数: 0

摘要

目的:多发性硬化症(MS)是一种中枢神经系统炎症性疾病,常见于育龄妇女。然而,抗 CD20 疗法尚未获得在妊娠期使用的许可。抗 CD20 单克隆抗体属于 IgG1 家族,有可能穿过胎盘,尤其是在妊娠 20 周以后。我们的目的是分析皮下注射抗 CD20 单克隆抗体 ofatumumab(OFA)对孕期的影响:我们介绍了一位患有多发性硬化症的妇女的病例,她意外地每 4 周服用一次 OFA 直到分娩。除了详细介绍母婴的临床和实验室结果外,我们还总结了有关孕期和哺乳期抗 CD20 治疗的现有证据:结果:我们的患者在估计孕周32-35周之间生下了一个健康的女孩。值得注意的是,在产后 3 个月和最后一次服用 OFA 4 个月后,母亲的 B 细胞仍完全耗竭,而孩子的 B 细胞计数则在正常范围内:讨论:需要更多数据来证实孕期的 OFA 治疗不会影响新生儿的 B 细胞。
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Impact of Continuous Ofatumumab Exposure During Pregnancy in Multiple Sclerosis.

Objectives: Anti-CD20 therapies are highly effective treatment options for patients with multiple sclerosis (MS), an inflammatory disorder of the CNS commonly affecting women of childbearing age. Anti-CD20 therapies are however unlicensed for use in pregnancy. Belonging to the IgG1 family, anti-CD20 monoclonal antibodies are likely to cross the placenta, especially after the 20th week of gestation. Our objective was to analyze the impact of ofatumumab (OFA), a subcutaneous anti-CD20 monoclonal antibody, during pregnancy.

Methods: We present the case of a woman with MS who accidentally administered OFA every 4 weeks until delivery. In addition to detailing the clinical and laboratory outcomes of both mother and child, we provide a summary of the available evidence regarding anti-CD20 treatment during pregnancy and breastfeeding.

Results: Our patient gave birth to a healthy girl between estimated gestational weeks 32-35. Notably, at 3 months postpartum and 4 months after the last OFA administration, the mother remained fully B-cell depleted while the B-cell counts of the child were within the normal range.

Discussion: Further data are necessary to confirm that OFA treatment during pregnancy does not affect neonatal B cells.

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来源期刊
Neurology. Clinical practice
Neurology. Clinical practice CLINICAL NEUROLOGY-
CiteScore
4.00
自引率
0.00%
发文量
77
期刊介绍: Neurology® Genetics is an online open access journal publishing peer-reviewed reports in the field of neurogenetics. The journal publishes original articles in all areas of neurogenetics including rare and common genetic variations, genotype-phenotype correlations, outlier phenotypes as a result of mutations in known disease genes, and genetic variations with a putative link to diseases. Articles include studies reporting on genetic disease risk, pharmacogenomics, and results of gene-based clinical trials (viral, ASO, etc.). Genetically engineered model systems are not a primary focus of Neurology® Genetics, but studies using model systems for treatment trials, including well-powered studies reporting negative results, are welcome.
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