%0 Journal Article
%T Neonatal B-Cell Levels and Infant Health in Newborns Potentially Exposed to Anti-CD20 Monoclonal Antibodies During Pregnancy or Lactation.
%A Schwake C
%A Steinle J
%A Thiel S
%A Timmesfeld N
%A Haben S
%A Ayzenberg I
%A Gold R
%A Hellwig K
%J Neurol Neuroimmunol Neuroinflamm
%V 11
%N 4
%D 2024 Jul
%M 38870458
%F 11.36
%R 10.1212/NXI.0000000000200264
%X <B>OBJECTIVE: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>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.