| Multiple sclerosis, immunomodulators, and pregnancy outcome: a prospective observational study. | |
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MedLine Citation:
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PMID: 19692433 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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C Weber-Schoendorfer; C Schaefer |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Multiple sclerosis (Houndmills, Basingstoke, England) Volume: 15 ISSN: 1352-4585 ISO Abbreviation: Mult. Scler. Publication Date: 2009 Sep |
Date Detail:
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Created Date: 2009-08-20 Completed Date: 2009-10-30 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9509185 Medline TA: Mult Scler Country: England |
Other Details:
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Languages: eng Pagination: 1037-42 Citation Subset: IM |
Affiliation:
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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. |
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| MeSH Terms | |
Descriptor/Qualifier:
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Abortion, Spontaneous
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epidemiology*,
immunology Adolescent Adult Birth Weight Cohort Studies Congenital Abnormalities / epidemiology*, immunology Female Humans Immunologic Factors / therapeutic use* Infant, Newborn Interferon-beta / therapeutic use Male Middle Aged Multiple Sclerosis* / drug therapy, epidemiology, immunology Peptides / therapeutic use Pregnancy Pregnancy Outcome / epidemiology* Risk Factors Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Immunologic Factors; 0/Peptides; 0/copolymer 1; 145155-23-3/interferon beta-1b; 145258-61-3/interferon beta 1a; 77238-31-4/Interferon-beta |
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