Abstract Details

Choosing suitable therapy models before pregnancy is challenging for MS patients because only few drugs are approved for usage during pregnancy. More data are necessary to find the best therapy with a balanced fetal and maternal risk.

To assess pregnancy outcomes in Multiple Sclerosis (MS) patients with/without pregnancy exposure to Disease Modifying Therapies (DMTs).

In this prospective, observational cohort from the German MS and Pregnancy Registry, we analyzed spontaneous abortions (SA), mean birth weight, preterm births, still births and major congenital abnormalities (MCA) in women with/without DMT pregnancy exposure, stratified into different DMT exposure groups (inferferon-b, glatiramer acetate, dimethyl fumarate, fingolimod, natalizumab, ocrelizumab/rituximab, others). 

We included 3363 pregnancies: 2622 with and 741 without DMT pregnancy exposure (control group). SA and MCA rate in the entire DMT exposed cohort were 8.5% (6.3% controls) and 3.6% (2.6% controls), respectively. No significant differences between the DMT exposure groups were observed for SA, preterm births and still births in the descriptive analysis. MCAs were more common in the fingolimod exposed group (8/135, 5.9%, 95% CI: 2.6, 11.3). In the linear regression model, fingolimod (b: -150g, 95% CI: -244, -55 p=0.002), high dose corticosteroid during pregnancy (b: -81g, 95% CI: -145, -17 p=0.018) and DMT exposure after the first trimester (b: -83g, 95% CI: -140, -26 p=0.004) were associated with a reduced birth weight. At the time of the meeting, updated data and results of the additional regression models will be presented. 

Most pregnancy outcomes are unaffected by DMT pregnancy exposure, but our data underline the potential risk of teratogenicity with fingolimod exposure. The findings that corticosteroid and fingolimod exposure and also DMT continuation (mainly NTZ) were associated with a reduced birth weight warrant further comparisons not only with unexposed pregnancies. Limitations include the small sample size of teriflunomide, alemtuzumab and cladribine exposed pregnancies.