Natalizumab during pregnancy and lactation. 2018

Undine Proschmann, and Katja Thomas, and Sandra Thiel, and Kerstin Hellwig, and Tjalf Ziemssen
Neuroimmunological Lab, Center of Clinical Neuroscience, Department of Neurology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany/Multiple Sclerosis Center, Center of Clinical Neuroscience, Department of Neurology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.

Managing medication during pregnancy and lactation in multiple sclerosis (MS) patients needs to balance potential risks to the newborn with the substantial risks of ongoing disease activity. To evaluate the potential transfer of natalizumab (NAT) into breast milk and into the serum of newborn babies in women who continued NAT treatment during pregnancy and lactation. Serum samples of 11 mother-infant pairs and mother milk samples of a further 4 women were analyzed for free NAT using a HL60 cell-based fluorescence-activated cell sorting (FACS) assay. Two mother-baby pairs were analyzed for cell-bound NAT, very-late-antigen (VLA)-4 expression, and saturation with NAT on immune cells by FACS analysis. In the majority of the mother-infant serum pairs (6/11) and in all breast milk samples, free NAT was detectable. Cell-bound NAT was measurable in both mother-baby pairs with significant higher levels in babies. VLA-4 expression seems to be higher in newborns. Saturation with NAT was comparable between newborns and mothers. NAT can pass placental barrier before delivery and into breast milk. Measurable NAT on neonatal lymphocytes may have functional impact. Further investigations are needed to clarify safety and risk of NAT exposure during pregnancy and lactation.

UI MeSH Term Description Entries
D007155 Immunologic Factors Biologically active substances whose activities affect or play a role in the functioning of the immune system. Biological Response Modifier,Biomodulator,Immune Factor,Immunological Factor,Immunomodulator,Immunomodulators,Biological Response Modifiers,Biomodulators,Factors, Immunologic,Immune Factors,Immunological Factors,Modifiers, Biological Response,Response Modifiers, Biological,Factor, Immune,Factor, Immunological,Factors, Immune,Factors, Immunological,Modifier, Biological Response,Response Modifier, Biological
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D007774 Lactation The processes of milk secretion by the maternal MAMMARY GLANDS after PARTURITION. The proliferation of the mammary glandular tissue, milk synthesis, and milk expulsion or let down are regulated by the interactions of several hormones including ESTRADIOL; PROGESTERONE; PROLACTIN; and OXYTOCIN. Lactation, Prolonged,Milk Secretion,Lactations, Prolonged,Milk Secretions,Prolonged Lactation,Prolonged Lactations
D008895 Milk, Human Milk that is produced by HUMAN MAMMARY GLANDS. Breast Milk,Human Milk,Milk, Breast
D011247 Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. Gestation,Pregnancies
D011248 Pregnancy Complications Conditions or pathological processes associated with pregnancy. They can occur during or after pregnancy, and range from minor discomforts to serious diseases that require medical interventions. They include diseases in pregnant females, and pregnancies in females with diseases. Adverse Birth Outcomes,Complications, Pregnancy,Adverse Birth Outcome,Birth Outcome, Adverse,Complication, Pregnancy,Outcome, Adverse Birth,Pregnancy Complication
D011297 Prenatal Exposure Delayed Effects The consequences of exposing the FETUS in utero to certain factors, such as NUTRITION PHYSIOLOGICAL PHENOMENA; PHYSIOLOGICAL STRESS; DRUGS; RADIATION; and other physical or chemical factors. These consequences are observed later in the offspring after BIRTH. Delayed Effects, Prenatal Exposure,Late Effects, Prenatal Exposure
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069442 Natalizumab A humanized monoclonal immunoglobulin G4 antibody to human INTEGRIN ALPHA4 that binds to the alpha4 subunit of INTEGRIN ALPHA4BETA1 and integrin alpha4beta7. It is used as an IMMUNOLOGIC FACTOR in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS and CROHN'S DISEASE. Antegren,Tysabri

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