Division Neurological Rehabilitation, Department of NEUROFARBA, University of Florence, Florence, Italy/IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.
Division Neurological Rehabilitation, Careggi University Hospital, Florence, Italy.
Mult Scler. 2022 Nov;28(13):2137-2141. doi: 10.1177/13524585221079598. Epub 2022 Mar 16.
To assess the impact of timing of natalizumab cessation/redosing on long-term maternal and infant outcomes in 72 out of the original 74 pregnancies of the Italian Pregnancy Dataset in multiple sclerosis (MS).
Maternal outcomes in patients who received natalizumab until conception and restarted the drug within 1 month after delivery ("treatment approach," (TA)) and patients who stopped natalizumab before conception and/or restarted the drug later than 1 month after delivery ("conservative approach," (CA)) were compared through multivariable Cox regression analyses. Pediatric outcomes were assessed through a semi-structured questionnaire.
After a mean follow-up of 6.1 years, CA (hazard ratio (HR) = 4.1, 95% CI 1.6-10.6, = 0.003) was the only predictor of relapse occurrence. Worsening on the Expanded Disability Status Scale (EDSS) was associated with higher annualized relapse-rate during the follow-up (HR = 3.3, 95% CI 1.4-7.9 = 0.007). We found no major development abnormalities in children.
Our data confirm that TA reduces the risk of disease activity; we did not observe an increase in major development abnormalities in the child.
评估多发性硬化症（MS）意大利妊娠数据集 74 例妊娠中的 72 例中，停用/重新开始那他珠单抗的时机对母婴长期结局的影响。
通过多变量 Cox 回归分析比较接受那他珠单抗直至妊娠并在分娩后 1 个月内重新开始药物治疗的患者（“治疗方法”（TA））和在妊娠前停止那他珠单抗和/或在分娩后 1 个月后重新开始药物治疗的患者（“保守方法”（CA））的母婴结局。通过半结构化问卷评估儿科结局。
平均随访 6.1 年后，CA（风险比（HR）=4.1，95%可信区间 1.6-10.6，=0.003）是复发发生的唯一预测因素。扩展残疾状况量表（EDSS）恶化与随访期间更高的年化复发率相关（HR=3.3，95%可信区间 1.4-7.9，=0.007）。我们未发现儿童有重大发育异常。
我们的数据证实 TA 降低了疾病活动的风险；我们未观察到儿童出现重大发育异常。
