PDF(Pubmed)
Abstract：
OBJECTIVE: 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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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.
摘要：
目的：报告在妊娠或哺乳前/期间暴露于抗CD20单克隆抗体≤6个月的母亲的婴儿的CD19+B细胞计数和可能的不良反应。
方法：我们使用德国全国范围的神经免疫妊娠登记数据进行了一项回顾性研究。纳入标准涉及母亲在怀孕或哺乳前/期间接受抗CD20mAb≤6个月的婴儿，产后CD19+B细胞计数≥1。主要结果是绝对和相对CD19+B细胞计数。在妊娠前/期间母体暴露≤3个月的亚组中保守地与参考值进行比较。其他结果包括妊娠结果，严重感染,和淋巴细胞计数。
结果：该队列包括49名婴儿（F:M25:24），在怀孕或哺乳前/期间暴露于抗CD20mAb≤6个月。40例孕妇在怀孕前/怀孕期间暴露≤3个月的婴儿的CD19B细胞和淋巴细胞计数与标准值相当。只有2例CD19+B细胞完全耗尽发生在孕中期和孕中期奥克瑞珠单抗暴露后，在2个月内观察到再种群。独家哺乳暴露对婴儿绝对CD19+B细胞计数没有显著影响。
结论：在妊娠前或妊娠时施用抗CD20单克隆抗体，或在哺乳期间，似乎是安全的，对婴儿B细胞发育没有显著影响。然而,妊娠中期或妊娠中期暴露可导致胎盘转移导致CD19+B细胞耗竭，需要监测和推迟活疫苗。
方法：我们使用德国全国范围的神经免疫妊娠登记数据进行了一项回顾性研究。纳入标准涉及母亲在怀孕或哺乳前/期间接受抗CD20mAb≤6个月的婴儿，产后CD19+B细胞计数≥1。主要结果是绝对和相对CD19+B细胞计数。在妊娠前/期间母体暴露≤3个月的亚组中保守地与参考值进行比较。其他结果包括妊娠结果，严重感染,和淋巴细胞计数。
结果：该队列包括49名婴儿（F:M25:24），在怀孕或哺乳前/期间暴露于抗CD20mAb≤6个月。40例孕妇在怀孕前/怀孕期间暴露≤3个月的婴儿的CD19B细胞和淋巴细胞计数与标准值相当。只有2例CD19+B细胞完全耗尽发生在孕中期和孕中期奥克瑞珠单抗暴露后，在2个月内观察到再种群。独家哺乳暴露对婴儿绝对CD19+B细胞计数没有显著影响。
结论：在妊娠前或妊娠时施用抗CD20单克隆抗体，或在哺乳期间，似乎是安全的，对婴儿B细胞发育没有显著影响。然而,妊娠中期或妊娠中期暴露可导致胎盘转移导致CD19+B细胞耗竭，需要监测和推迟活疫苗。
