Document Detail


Pregnancy and fetal outcomes after interferon-β exposure in multiple sclerosis.
MedLine Citation:
PMID:  21079181     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To assess pregnancy and fetal outcomes after in utero exposure to interferon-β (IFNβ) in all pregnancies occurring in women with multiple sclerosis (MS) during the study period, with a specific focus on the risk of spontaneous abortion.
METHODS: In this cohort study, data were gathered through a standardized, semi-structured interview. Patients who discontinued IFNβ less than 4 weeks from conception (exposed) were compared with those who had discontinued the drug at least 4 weeks from conception or who were never treated (not exposed). Possible confounders were handled through multivariate analyses adjusted for propensity score (PS).
RESULTS: We collected data on 396 pregnancies in 388 women, 88 classified as exposed (mean exposure 4.6 ± 5.8 weeks). IFNβ exposure was not associated with an increased risk of spontaneous abortion (PS-adjusted odds ratio [OR] 1.08, 95% confidence interval [CI] 0.4 to 2.9, p = 0.88), although it was associated with both lower baby weight (PS-adjusted β -113.8, p < 0.0001) and length (PS-adjusted β -1.102, p < 0.0001). Proportion of spontaneous abortion in exposed patients fell within the range expected for the Italian population in the same period. IFNβ exposure (PS-adjusted OR 2.11, 95% CI 1.18 to 3.78, p = 0.012) and cesarean delivery were the only predictors of preterm delivery. In the exposed group, we did not observe any significant fetal complications, malformations, or developmental abnormalities over a median follow-up of 2.1 years.
CONCLUSIONS: Our findings point to the relative safety of IFNβ exposure times of up to 4 weeks and can assist neurologists facing therapeutic decisions in women with MS with a pregnancy plan.
Authors:
M P Amato; E Portaccio; A Ghezzi; B Hakiki; V Zipoli; V Martinelli; L Moiola; F Patti; L La Mantia; G L Mancardi; C Solaro; M R Tola; C Pozzilli; L De Giglio; R Totaro; A Lugaresi; V Di Tommaso; D Paolicelli; M G Marrosu; G Comi; F Pellegrini; M Trojano;
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study    
Journal Detail:
Title:  Neurology     Volume:  75     ISSN:  1526-632X     ISO Abbreviation:  Neurology     Publication Date:  2010 Nov 
Date Detail:
Created Date:  2010-11-16     Completed Date:  2010-12-14     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0401060     Medline TA:  Neurology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1794-802     Citation Subset:  AIM; IM    
Affiliation:
Department of Neurology, University of Florence, Florence, Italy. mariapia.amato@unifi.it
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MeSH Terms
Descriptor/Qualifier:
Abortion, Spontaneous / chemically induced*,  etiology,  physiopathology
Adult
Cohort Studies
Female
Fetal Diseases / chemically induced,  diagnosis,  physiopathology
Fetal Weight / drug effects
Follow-Up Studies
Humans
Infant, Newborn
Interferon-beta / adverse effects,  therapeutic use*
Male
Multiple Sclerosis / complications,  drug therapy*
Pregnancy
Pregnancy Outcome / epidemiology
Prospective Studies
Chemical
Reg. No./Substance:
77238-31-4/Interferon-beta
Investigator
Investigator/Affiliation:
Maria Pia Amato / ; Emilio Portaccio / ; Bahia Hakiki / ; Valentina Zipoli / ; Gianfranco Siracusa / ; Angelo Ghezzi / ; Annalisa Rizzo / ; Mauro Zaffaroni / ; Vittorio Martinelli / ; Marta Radaelli / ; Lucia Moiola / ; Giancarlo Comi / ; Clara Milanese / ; Loredana La Mantia / ; Alessandra Protti / ; Chiara Spreafico / ; Raffaella Marazzi / ; Paola Cavalla / ; Silvia Masera / ; Roberto Bergamaschi / ; Gian Luigi Mancardi / ; Elisabetta Capello / ; Claudio Solaro / ; Federica Molinari / ; Maria Rosaria Tola / ; Luisa Caniatti / ; Franco Granella / ; Paolo Immovilli / ; Pasquale Annunziata / ; Lorenzo De Santi / ; Katrin Plewnia / ; Leonello Guidi / ; Maria Letizia Bartolozzi / ; Monica Mazzoni / ; Carlo Pozzilli / ; Laura De Giglio / ; Rocco Totaro / ; Alessandra Lugaresi / ; Valeria Di Tommaso / ; Giovanna De Luca / ; Maria Trojano / ; Damiano Paolicelli / ; Alessandro Carrozzo / ; Mariangela D'Onghia / ; Maria Giovanna Marrosu / ; Luigina Musu / ; Francesco Patti / ; Tiziana Cavallaro / ; Fabio Pellegrini /

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