Department of Neurology, University of Florence, Florence, Italy.
Neurology. 2010 Nov 16;75(20):1794-802. doi: 10.1212/WNL.0b013e3181fd62bb.
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.
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).
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.
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.
评估研究期间多发性硬化症（MS）女性所有妊娠的胎儿结局和妊娠情况，特别关注自然流产风险。
本队列研究通过标准化半结构式访谈收集数据。将妊娠 4 周内停药的患者（暴露组）与妊娠 4 周后停药或从未接受治疗的患者（未暴露组）进行比较。通过多变量分析调整倾向评分（PS）处理混杂因素。
共收集了 388 名女性的 396 例妊娠数据，88 例归类为暴露组（平均暴露时间为 4.6±5.8 周）。IFNβ 暴露与自然流产风险增加无关（PS 调整后的优势比 [OR] 1.08，95%置信区间 [CI] 0.4 至 2.9，p = 0.88），但与婴儿体重较低（PS 调整后 -113.8，p<0.0001）和长度较短（PS 调整后 -1.102，p<0.0001）相关。暴露组的自然流产比例在同期意大利人群的预期范围内。IFNβ 暴露（PS 调整后 OR 2.11，95% CI 1.18 至 3.78，p = 0.012）和剖宫产是早产的唯一预测因素。在暴露组中，我们未观察到任何显著的胎儿并发症、畸形或发育异常，中位随访时间为 2.1 年。
我们的研究结果表明 IFNβ 暴露时间长达 4 周相对安全，可帮助神经科医生在有妊娠计划的 MS 女性中做出治疗决策。
