C Weber-Schoendorfer1, C Schaefer. 1. Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie Berlin, Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Berliner Betrieb für Zentrale Gesundheitliche Aufgaben, Berlin, Germany.
Abstract
BACKGROUND: There is still uncertainty about the management of pregnant women exposed to immunomodulatory therapy for treatment of multiple sclerosis (MS) in pregnancy. OBJECTIVE: To assess the safety of interferon (IFN)-beta1a, IFN-beta1b, and glatiramer acetate (GA) for treatment of MS during pregnancy. METHODS: A prospective observational cohort study was performed with patients enrolled through a drug risk assessment by the Teratology Information Service (TIS), Berlin, from 1996 to 2007. Pregnancy outcomes for four groups of women were compared: two exposed groups (IFN, n = 69; GA, n = 31), MS patients without exposure to IFN or GA (n = 64) and a healthy comparative group (n = 1556). RESULTS: Spontaneous abortion rates were in normal range for all groups except the small subgroup of IFN-beta1b exposed (n = 21), where 28% aborted spontaneously. There were two major birth defects in the GA group (club feet and atrioventricular canal) and none in the IFN cohort. Preterm delivery was not significantly different between exposed cohorts and healthy controls. The adjusted mean birth weight was in normal range in all groups (>3200 g), but newborns exposed to IFN had a significantly lower birth weight. CONCLUSION: Our findings suggest that neither GA nor IFN constitutes a major risk for prenatal developmental toxicity.
BACKGROUND: There is still uncertainty about the management of pregnant women exposed to immunomodulatory therapy for treatment of multiple sclerosis (MS) in pregnancy. OBJECTIVE: To assess the safety of interferon (IFN)-beta1a, IFN-beta1b, and glatiramer acetate (GA) for treatment of MS during pregnancy. METHODS: A prospective observational cohort study was performed with patients enrolled through a drug risk assessment by the Teratology Information Service (TIS), Berlin, from 1996 to 2007. Pregnancy outcomes for four groups of women were compared: two exposed groups (IFN, n = 69; GA, n = 31), MS patients without exposure to IFN or GA (n = 64) and a healthy comparative group (n = 1556). RESULTS: Spontaneous abortion rates were in normal range for all groups except the small subgroup of IFN-beta1b exposed (n = 21), where 28% aborted spontaneously. There were two major birth defects in the GA group (club feet and atrioventricular canal) and none in the IFN cohort. Preterm delivery was not significantly different between exposed cohorts and healthy controls. The adjusted mean birth weight was in normal range in all groups (>3200 g), but newborns exposed to IFN had a significantly lower birth weight. CONCLUSION: Our findings suggest that neither GA nor IFN constitutes a major risk for prenatal developmental toxicity.
Authors: Goeril Karlsson; Gordon Francis; Gideon Koren; Peter Heining; Xiaoli Zhang; Jeffrey A Cohen; Ludwig Kappos; William Collins Journal: Neurology Date: 2014-01-24 Impact factor: 9.910