• J. Neurol. Neurosurg. Psychiatr. · May 2024

    Observational Study

    Disease activity and neonatal outcomes after exposure to natalizumab throughout pregnancy.

    • Sandra Thiel, Nastassja Litvin, Sabrina Haben, Ralf Gold, and Kerstin Hellwig.
    • Universitätsklinik für Neurologie der Ruhr-Universität Bochum, Katholisches Klinikum Bochum Sankt Josef-Hospital, Bochum, Nordrhein-Westfalen, Germany Sandra.Thiel@ruhr-uni-bochum.de.
    • J. Neurol. Neurosurg. Psychiatr. 2024 May 14; 95 (6): 561570561-570.

    BackgroundAfter natalizumab discontinuation severe relapses can occur despite pregnancy, but third trimester exposure is associated with neonatal haematological abnormalities (HA). The best time point for stopping natalizumab during pregnancy is unclear.MethodsProspective, observational cohort with 350 natalizumab exposed pregnancies from the German Multiple Sclerosis and Pregnancy Registry. Clinical disease activity and neonatal outcomes are compared between women with natalizumab discontinuation during (1st Trim-group) versus after the first trimester (maintaining-group) and for subgroup analysis before (<30-subgroup) or after (≥30-subgroup) the 30th gestational week (gw).ResultsBaseline characteristics did not significantly differ between the 1st Trim-group (n=179; median exposure duration: 2.60 gw, IQR 1.30-3.60) and the maintaining-group (n=171; median exposure duration: 30.9 gw, IQR 26.9-33.3). Fewer relapses occurred during pregnancy and the postpartum year in the maintaining-group (25.7%) compared with the 1st Trim-group (62.6%; p<0.001). Women in ≥30-subgroup had a significantly lower relapse risk in the first 6 months postpartum (relapse rate ratio: 0.36, 95% CI: 0.15 to 0.84). In total, 7.5% retained meaningful disability 12 months postpartum. No significant effect on neonatal outcomes were observed, but anaemia (OR: 2.62, 95% CI: 1.12 to 6.52) and thrombocytopaenia (OR: 2.64, 95% CI: 1.15 to 6.46) were significantly more common in the ≥30-subgroup. 21.8% of all neonates were born small for gestational age, independent of the timing of natalizumab discontinuation.ConclusionContinuing natalizumab during pregnancy after gw 30 decreases the relapse risk postpartum going along with a higher risk for HA in the newborns. These results add relevant knowledge as a basis for informed risk-benefit discussion.© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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