Simon Hefner, Tiago Lerda Casaccia, Edda Hofstaetter, Ferdinand Otto, Kerstin Hellwig, Tobias Moser
{"title":"多发性硬化症患者妊娠期持续接触奥法妥木单抗的影响","authors":"Simon Hefner, Tiago Lerda Casaccia, Edda Hofstaetter, Ferdinand Otto, Kerstin Hellwig, Tobias Moser","doi":"10.1212/CPJ.0000000000200410","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Discussion: </strong>Further data are necessary to confirm that OFA treatment during pregnancy does not affect neonatal B cells.</p>","PeriodicalId":19136,"journal":{"name":"Neurology. Clinical practice","volume":"15 1","pages":"e200410"},"PeriodicalIF":2.3000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11547831/pdf/","citationCount":"0","resultStr":"{\"title\":\"Impact of Continuous Ofatumumab Exposure During Pregnancy in Multiple Sclerosis.\",\"authors\":\"Simon Hefner, Tiago Lerda Casaccia, Edda Hofstaetter, Ferdinand Otto, Kerstin Hellwig, Tobias Moser\",\"doi\":\"10.1212/CPJ.0000000000200410\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Discussion: </strong>Further data are necessary to confirm that OFA treatment during pregnancy does not affect neonatal B cells.</p>\",\"PeriodicalId\":19136,\"journal\":{\"name\":\"Neurology. Clinical practice\",\"volume\":\"15 1\",\"pages\":\"e200410\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2025-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11547831/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Neurology. Clinical practice\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1212/CPJ.0000000000200410\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/11/7 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Neurology. Clinical practice","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1212/CPJ.0000000000200410","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/11/7 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
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.
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.