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. Copyright © 2010 by AAN Enterprises, Inc.
Pregnancy and fetal outcomes after interferon-β exposure in multiple sclerosis / Amato, M. P.; Portaccio, E.; Ghezzi, A.; Hakiki, B.; Zipoli, V.; Martinelli, V.; Moiola, L.; Patti, F.; La Mantia, L.; Mancardi, G. L.; Solaro, C.; Tola, M. R.; Pozzilli, C.; De Giglio, L.; Totaro, R.; Lugaresi, A.; Di Tommaso, V.; Paolicelli, D.; Marrosu, M. G.; Comi, G.; Pellegrini, F.; Trojano, M.; Siracusa, G.; Rizzo, A.; Zaffaroni, M.; Radaelli, M.; Milanese, C.; Protti, A.; Spreafico, C.; Marazzi, R.; Cavalla, P.; Masera, S.; Bergamaschi, R.; Capello, E.; Molinari, F.; Caniatti, L.; Granella, F.; Immovilli, P.; Annunziata, P.; De Santi, L.; Plewnia, K.; Guidi, L.; Bartolozzi, M. L.; Mazzoni, M.; De Giglio, L.; Di Tommaso, V.; De Luca, Giovanna; Carrozzo, A.; D'Onghia, M.; Musu, L.; Cavallaro, T.. - In: NEUROLOGY. - ISSN 0028-3878. - 75:20(2010), pp. 1794-1802. [10.1212/WNL.0b013e3181fd62bb]
Pregnancy and fetal outcomes after interferon-β exposure in multiple sclerosis
Comi, G.;Radaelli, M.Membro del Collaboration Group
;
2010-01-01
Abstract
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. Copyright © 2010 by AAN Enterprises, Inc.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
