Monoclonal antibody treatment during pregnancy and/or lactation in women with MS or neuromyelitis optica spectrum disorder

• Published in: Neurology : neuroimmunology & neuroinflammation 2020-07, Vol.7 (4), p.e723-e723
• Main Authors: Ciplea, Andrea Ines, Langer-Gould, Annette, de Vries, Annick, Schaap, Tiny, Thiel, Sandra, Ringelstein, Marius, Gold, Ralf, Hellwig, Kerstin
• Format: Article
• Language: English
• Subjects: Adult; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - metabolism; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - metabolism; Antigens, CD20 - immunology; Birth Weight - drug effects; Breast Feeding; Female; Follow-Up Studies; Hospitalization; Humans; Immunologic Factors - adverse effects; Immunologic Factors - metabolism; Infant; Lactation; Milk, Human - metabolism; Multiple Sclerosis - drug therapy; Natalizumab - adverse effects; Natalizumab - metabolism; Neuromyelitis Optica - drug therapy; Postpartum Period; Pregnancy; Pregnancy Complications - drug therapy; Pregnancy Trimester, Third; Prenatal Exposure Delayed Effects - chemically induced; Registries; Rituximab - adverse effects; Rituximab - metabolism
• ISSN: 2332-7812; 2332-7812
• DOI: 10.1212/NXI.0000000000000723

To assess possible adverse effects on breastfed infants of mothers receiving monoclonal antibodies (MAbs) during pregnancy and/or lactation. We identified 23 patients from the German Multiple Sclerosis and Pregnancy Registry (DMSKW) who received MAbs (17 natalizumab and 6 anti-CD20) during lactation. Thirteen were already exposed to natalizumab during the third trimester of pregnancy, and 1 received ocrelizumab during pregnancy. Data were obtained from standardized, telephone-administered questionnaires completed by the mother during pregnancy and at 1, 3, 6, and 12 months postpartum. Natalizumab concentration in mother's milk was analyzed in 3 patients and natalizumab serum concentration in 2 of these patients and their breastfed infants. We did not observe a negative impact on infant health and development attributable to breast milk exposure after a median follow-up of 1 year. Infants exposed to natalizumab during the third trimester had a lower birth weight and more hospitalizations in the first year of life. The concentration of natalizumab in breast milk and serum of infants was low; B cells normal in infants breastfed under anti-CD20. More data on the effect of Mab exposure during pregnancy are needed. Otherwise, our data suggest that treatment with natalizumab, ocrelizumab, or rituximab during lactation might be safe for breastfed infants.