From the Katholisches Klinikum Bochum (K.H.), Ruhr University, Germany; Manchester Centre for Clinical Neurosciences (D.R.), Salford Royal NHS Foundation Trust, United Kingdom; Department of Neurology (C.M.), St. Vincent's University Hospital & University College, Dublin, Ireland; Partners MS Center (M.K.H.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Adult Neurology Clinic (D.R.B.), Charlottesville, VA; and Biogen (O.M., F.B., X.P., N.J.E.), Cambridge, MA.
Neurol Neuroimmunol Neuroinflamm. 2021 Nov 23;9(1). doi: 10.1212/NXI.0000000000001114. Print 2022 Jan.
Oral delayed-release dimethyl fumarate (DMF) is not recommended during pregnancy and should only be used if the potential benefit justifies the potential fetal risk. Although DMF was well tolerated in clinical trials with consistent safety results in postmarketing surveillance, data are limited in pregnant women. The objective was to provide pregnancy outcomes and DMF exposure information from an interim analysis from a prospective, international registry (TecGistry; NCT01911767).
Women exposed to DMF from the first day of their last menstrual period before conception or during pregnancy were evaluated. Data were obtained at enrollment; 6-7 months' gestation; 4 weeks after estimated due date; and 4, 12, and 52 weeks after birth. Outcomes included live births, gestational size, pregnancy loss, birth defects, and infant or maternal death after delivery. Outcomes were analyzed cumulatively from October 30, 2013 (the start of TecGistry), to April 8, 2020.
Of 345 enrolled patients, median (range) age was 32 (20-43) years. The mean (SD) duration of gestational weeks of DMF exposure was 4.9 (3.8). Most infants were full-term at birth (n = 249/274; 91%) and of average gestational size (n = 190/232; 82%). Of 351 outcomes, 277 were live births; 17 (5%) spontaneous abortions (95% confidence interval [CI] 2.6%-7.1%), including 1 (<1%) molar and 1 (<1%) ectopic pregnancy, were reported. There were 8 (2.9% [95% CI 1.3%-5.6%]) adjudicator-confirmed birth defects among the 277 live births.
Interim results from this large registry indicate that early DMF exposure was not significantly associated with adverse pregnancy outcomes. Outcomes are consistent with previous smaller reports and with the general population.
TecGistry; clinical trial registration number: NCT01911767.
口服延迟释放富马酸二甲酯（DMF）不建议在怀孕期间使用，只有在潜在益处超过潜在胎儿风险的情况下才应使用。尽管 DMF 在临床试验中得到了很好的耐受，并且上市后监测中也有一致的安全性结果，但在孕妇中的数据有限。本研究的目的是提供 TecGistry 前瞻性国际注册研究（NCT01911767）的中期分析中来自孕妇的妊娠结局和 DMF 暴露信息。
评估在受孕前末次月经第一天或怀孕期间开始接触 DMF 的女性。在入组时、妊娠 6-7 个月、预计预产期 4 周后、产后 4、12 和 52 周时获取数据。结局包括活产、妊娠大小、妊娠丢失、出生缺陷和分娩后婴儿或产妇死亡。结局从 2013 年 10 月 30 日（TecGistry 开始）至 2020 年 4 月 8 日进行累积分析。
345 名入组患者的中位（范围）年龄为 32（20-43）岁。DMF 暴露的平均（标准差）孕周为 4.9（3.8）周。大多数婴儿在出生时为足月（n=249/274；91%）且妊娠大小正常（n=190/232；82%）。在 351 个结局中，277 例为活产；17 例（5%）自然流产（95%置信区间[CI] 2.6%-7.1%），包括 1 例（<1%）葡萄胎和 1 例（<1%）异位妊娠，报告 8 例（2.9%[95%CI 1.3%-5.6%]）经裁判确认的出生缺陷。
来自这个大型注册研究的中期结果表明，早期 DMF 暴露与不良妊娠结局无显著相关性。结局与之前较小的报告和一般人群一致。
TecGistry；临床试验注册号：NCT01911767。
