{"title":"妊娠期或哺乳期可能接触抗CD20单克隆抗体的新生儿B细胞水平和婴儿健康。","authors":"Carolin Schwake, Julia Steinle, Sandra Thiel, Nina Timmesfeld, Sabrina Haben, Ilya Ayzenberg, Ralf Gold, Kerstin Hellwig","doi":"10.1212/NXI.0000000000200264","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>To report CD19<sup>+</sup> B-cell counts and possible adverse effects on infants of mothers exposed to anti-CD20 mAbs ≤6 months before/during pregnancy or lactation.</p><p><strong>Methods: </strong>We conducted a retrospective study using data from the German nationwide neuroimmunologic pregnancy registry. Inclusion criteria involved infants whose mothers received anti-CD20 mAbs ≤6 months before/during pregnancy or lactation, with ≥1 postnatal CD19<sup>+</sup> B-cell count. Main outcomes were absolute and relative CD19<sup>+</sup> B-cell counts. Comparison with reference values was performed conservatively in a subgroup with maternal exposure ≤3 months before/during pregnancy. Additional outcomes included pregnancy results, severe infections, and lymphocyte counts.</p><p><strong>Results: </strong>The cohort comprised 49 infants (F:M 25:24) exposed to anti-CD20 mAbs ≤6 months before/during pregnancy or lactation. CD19<sup>+</sup> B-cell and lymphocyte counts in 40 infants with maternal exposure ≤3 months before/during pregnancy were comparable with normative values. Only 2 cases of complete CD19<sup>+</sup> B-cell depletion occurred after second-trimester and third-trimester ocrelizumab exposure, with repopulation observed within 2 months. Exclusive lactation exposure had no significant effect on infants' absolute CD19<sup>+</sup> B-cell counts.</p><p><strong>Discussion: </strong>Administering anti-CD20 mAbs before or at the pregnancy onset, or during lactation, seems safe without significant impact on infant B-cell development. However, second-trimester or third-trimester exposure can cause CD19<sup>+</sup> B-cell depletion due to placental transfer, necessitating monitoring and postponing live vaccines.</p>","PeriodicalId":19472,"journal":{"name":"Neurology® Neuroimmunology & Neuroinflammation","volume":"11 4","pages":"e200264"},"PeriodicalIF":7.8000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11178251/pdf/","citationCount":"0","resultStr":"{\"title\":\"Neonatal B-Cell Levels and Infant Health in Newborns Potentially Exposed to Anti-CD20 Monoclonal Antibodies During Pregnancy or Lactation.\",\"authors\":\"Carolin Schwake, Julia Steinle, Sandra Thiel, Nina Timmesfeld, Sabrina Haben, Ilya Ayzenberg, Ralf Gold, Kerstin Hellwig\",\"doi\":\"10.1212/NXI.0000000000200264\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>To report CD19<sup>+</sup> B-cell counts and possible adverse effects on infants of mothers exposed to anti-CD20 mAbs ≤6 months before/during pregnancy or lactation.</p><p><strong>Methods: </strong>We conducted a retrospective study using data from the German nationwide neuroimmunologic pregnancy registry. Inclusion criteria involved infants whose mothers received anti-CD20 mAbs ≤6 months before/during pregnancy or lactation, with ≥1 postnatal CD19<sup>+</sup> B-cell count. Main outcomes were absolute and relative CD19<sup>+</sup> B-cell counts. Comparison with reference values was performed conservatively in a subgroup with maternal exposure ≤3 months before/during pregnancy. Additional outcomes included pregnancy results, severe infections, and lymphocyte counts.</p><p><strong>Results: </strong>The cohort comprised 49 infants (F:M 25:24) exposed to anti-CD20 mAbs ≤6 months before/during pregnancy or lactation. CD19<sup>+</sup> B-cell and lymphocyte counts in 40 infants with maternal exposure ≤3 months before/during pregnancy were comparable with normative values. Only 2 cases of complete CD19<sup>+</sup> B-cell depletion occurred after second-trimester and third-trimester ocrelizumab exposure, with repopulation observed within 2 months. Exclusive lactation exposure had no significant effect on infants' absolute CD19<sup>+</sup> B-cell counts.</p><p><strong>Discussion: </strong>Administering anti-CD20 mAbs before or at the pregnancy onset, or during lactation, seems safe without significant impact on infant B-cell development. However, second-trimester or third-trimester exposure can cause CD19<sup>+</sup> B-cell depletion due to placental transfer, necessitating monitoring and postponing live vaccines.</p>\",\"PeriodicalId\":19472,\"journal\":{\"name\":\"Neurology® Neuroimmunology & Neuroinflammation\",\"volume\":\"11 4\",\"pages\":\"e200264\"},\"PeriodicalIF\":7.8000,\"publicationDate\":\"2024-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11178251/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Neurology® Neuroimmunology & Neuroinflammation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1212/NXI.0000000000200264\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/6/13 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Neurology® Neuroimmunology & Neuroinflammation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1212/NXI.0000000000200264","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/6/13 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的报告在妊娠前/妊娠期间或哺乳期暴露于抗 CD20 mAbs ≤6 个月的母亲的 CD19+ B 细胞计数以及可能对婴儿产生的不良影响:我们利用德国全国神经免疫妊娠登记处的数据进行了一项回顾性研究。纳入标准包括母亲在怀孕前/怀孕期间或哺乳期接受抗 CD20 mAbs 治疗≤6 个月,且出生后 CD19+ B 细胞计数≥1 的婴儿。主要结果为CD19+ B细胞绝对计数和相对计数。在孕前/孕期母体暴露时间≤3个月的亚组中,与参考值进行了保守比较。其他结果包括妊娠结果、严重感染和淋巴细胞计数:该组包括49名在怀孕前/怀孕期间或哺乳期接触抗CD20 mAbs≤6个月的婴儿(女:男,25:24)。母体在怀孕前/怀孕期间接触抗CD20 mAbs≤3个月的40名婴儿的CD19+B细胞和淋巴细胞计数与正常值相当。只有 2 例 CD19+ B 细胞在妊娠第二和第三期接触奥克立珠单抗后完全耗竭,并在 2 个月内重新增殖。纯母乳喂养对婴儿的CD19+ B细胞绝对数量没有明显影响:讨论:在妊娠前、妊娠开始时或哺乳期使用抗 CD20 mAbs 似乎是安全的,不会对婴儿的 B 细胞发育产生重大影响。然而,妊娠第二或第三期接触可因胎盘转移而导致 CD19+ B 细胞耗竭,因此有必要进行监测并推迟接种活疫苗。
Neonatal B-Cell Levels and Infant Health in Newborns Potentially Exposed to Anti-CD20 Monoclonal Antibodies During Pregnancy or Lactation.
Objectives: To report CD19+ B-cell counts and possible adverse effects on infants of mothers exposed to anti-CD20 mAbs ≤6 months before/during pregnancy or lactation.
Methods: We conducted a retrospective study using data from the German nationwide neuroimmunologic pregnancy registry. Inclusion criteria involved infants whose mothers received anti-CD20 mAbs ≤6 months before/during pregnancy or lactation, with ≥1 postnatal CD19+ B-cell count. Main outcomes were absolute and relative CD19+ B-cell counts. Comparison with reference values was performed conservatively in a subgroup with maternal exposure ≤3 months before/during pregnancy. Additional outcomes included pregnancy results, severe infections, and lymphocyte counts.
Results: The cohort comprised 49 infants (F:M 25:24) exposed to anti-CD20 mAbs ≤6 months before/during pregnancy or lactation. CD19+ B-cell and lymphocyte counts in 40 infants with maternal exposure ≤3 months before/during pregnancy were comparable with normative values. Only 2 cases of complete CD19+ B-cell depletion occurred after second-trimester and third-trimester ocrelizumab exposure, with repopulation observed within 2 months. Exclusive lactation exposure had no significant effect on infants' absolute CD19+ B-cell counts.
Discussion: Administering anti-CD20 mAbs before or at the pregnancy onset, or during lactation, seems safe without significant impact on infant B-cell development. However, second-trimester or third-trimester exposure can cause CD19+ B-cell depletion due to placental transfer, necessitating monitoring and postponing live vaccines.
期刊介绍:
Neurology Neuroimmunology & Neuroinflammation is an official journal of the American Academy of Neurology. Neurology: Neuroimmunology & Neuroinflammation will be the premier peer-reviewed journal in neuroimmunology and neuroinflammation. This journal publishes rigorously peer-reviewed open-access reports of original research and in-depth reviews of topics in neuroimmunology & neuroinflammation, affecting the full range of neurologic diseases including (but not limited to) Alzheimer's disease, Parkinson's disease, ALS, tauopathy, and stroke; multiple sclerosis and NMO; inflammatory peripheral nerve and muscle disease, Guillain-Barré and myasthenia gravis; nervous system infection; paraneoplastic syndromes, noninfectious encephalitides and other antibody-mediated disorders; and psychiatric and neurodevelopmental disorders. Clinical trials, instructive case reports, and small case series will also be featured.