Objective: To assess pregnancy and fetal outcomes after in utero exposure to interferon-beta (IFN beta) 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 IFN beta 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). IFN beta 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 beta -113.8, p < 0.0001) and length (PS-adjusted beta -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. IFN beta 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 IFN beta exposure times of up to 4 weeks and can assist neurologists facing therapeutic decisions in women with MS with a pregnancy plan. Neurology (R) 2010;75:1794-1802
Pregnancy and fetal outcomes after interferon-beta exposure in multiple sclerosis / 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; Pozzilli, Carlo; L., De Giglio; R., Totaro; A., Lugaresi; V., Di Tommaso; D., Paolicelli; M. G., Marrosu; G., Comi; F., Pellegrini; M., Trojano; M. S., Study Group Of The Italian Neurological Society. - In: NEUROLOGY. - ISSN 0028-3878. - 75:(2010), pp. 1794-1802. [10.1212/wnl.0b013e3181fd62bb]
Pregnancy and fetal outcomes after interferon-beta exposure in multiple sclerosis
POZZILLI, Carlo;
2010
Abstract
Objective: To assess pregnancy and fetal outcomes after in utero exposure to interferon-beta (IFN beta) 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 IFN beta 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). IFN beta 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 beta -113.8, p < 0.0001) and length (PS-adjusted beta -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. IFN beta 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 IFN beta exposure times of up to 4 weeks and can assist neurologists facing therapeutic decisions in women with MS with a pregnancy plan. Neurology (R) 2010;75:1794-1802I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
