Thiel Sandra, Ciplea Andrea I, Gold Ralf, Hellwig Kerstin
Department of Neurology, St. Josef Hospital - Katholisches Klinikum Bochum GmbH, Ruhr University Bochum, Bochum, Germany.
Department of Neurology, St. Josef Hospital - Katholisches Klinikum Bochum GmbH, Ruhr University Bochum, Gudrunstrasse 56, 44791 Bochum, Germany.
Ther Adv Neurol Disord. 2021 Nov 22;14:17562864211054956. doi: 10.1177/17562864211054956. eCollection 2021.
Multiple sclerosis (MS) and neuromyelitis optica spectrum disorders (NMOSD) predominantly affect women of reproductive age. During the last few decades many disease-modifying therapies (DMTs) have been approved. It is therefore important to provide epidemiological structures for the collection of safety information on exposed pregnancies. Data on disease activity after withdrawal of DMTs are in high demand especially as severe relapses have been described after ceasing highly effective DMTs. Although breastfeeding is recommended, it is still unclear if the early reintroduction, especially of highly effective DMTs, has a beneficial effect on postpartum relapse risk or a combination of both, however safety data are lacking.
The German MS and Pregnancy Registry (DMSKW) is a nationwide, observational, cohort study of pregnant women with MS or NMOSD, founded in 2006. As the study procedure has undergone important adaptation in recent years, described here is the updated methodology including data source and acquisition as well as variables collected within the DMSKW.
As of December 2020, the DMSKW database comprises 2579 pregnancies, 2568 with MS and 11 with NMOSD. Women are enrolled at a median gestational week of 11 (range: 0.02-42.1), have a median postpartum follow up of 1.2 years (range: 0-9.2) with 76% of all pregnancies being exposed to a DMT, mostly in the first trimester. Spontaneous abortion and preterm birth occurred in 7% and 10%, respectively; 19% of all women suffered from at least one relapse during pregnancy, with a minimum of 6% during the third trimester of pregnancy.
The DMSKW is a valuable structure in providing safety data on drug exposure during pregnancy and lactation in combination with information on disease activity up to 6 years postpartum. This article will be the reference for describing the methods of future publications from the DMSKW.
多发性硬化症（MS）和视神经脊髓炎谱系障碍（NMOSD）主要影响育龄女性。在过去几十年中，许多疾病修正治疗（DMT）已获批准。因此，提供用于收集暴露于DMT的妊娠安全性信息的流行病学结构非常重要。尤其是在停用高效DMT后出现严重复发的情况下，对DMT停药后疾病活动的数据需求很高。尽管推荐母乳喂养，但早期重新使用，尤其是高效DMT，对产后复发风险是否有有益影响或两者的综合影响仍不清楚，然而缺乏安全性数据。
德国MS与妊娠登记处（DMSKW）是一项针对患有MS或NMOSD的孕妇的全国性观察性队列研究，于2006年成立。由于近年来研究程序经历了重要调整，本文描述了更新后的方法，包括数据来源和获取以及DMSKW内收集的变量。
截至2020年12月，DMSKW数据库包含2579例妊娠，其中2568例患有MS，11例患有NMOSD。女性入组时的孕周中位数为11周（范围：0.02 - 42.1），产后随访中位数为1.2年（范围：0 - 9.2），所有妊娠中有76%暴露于DMT，大多在孕早期。自然流产和早产分别发生在7%和10%；所有女性中有19%在孕期至少经历一次复发，孕晚期至少为6%。
DMSKW是一个宝贵的结构，可提供孕期和哺乳期药物暴露的安全性数据以及产后长达6年的疾病活动信息。本文将作为描述DMSKW未来出版物方法的参考。
