Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

If you have multiple sclerosis (MS) and are pregnant or planning to be, you might be wondering about the safety of your MS medications. This study, called a Pregnancy Exposure Registry, focuses on a specific MS medicine called Vumerity (diroximel fumarate). Its main purpose is to gather important information about how babies are affected when their mothers took Vumerity during early pregnancy, specifically looking at any common birth defects. Doctors need to understand this better to give the best advice to women with MS.

The study will carefully compare groups of women. They'll look at pregnant women with MS who took Vumerity from just before they realised they were pregnant and throughout their first trimester. Their babies' health will be compared to babies born to mothers with MS who didn't take any disease-modifying therapies (DMTs) – these are medicines used to treat MS. They will also compare them to babies whose mothers took other MS treatments, like Avonex or Tysabri, which have their own pregnancy registries.

Beyond just looking at early pregnancy and birth defects, the study is also interested in all other pregnancy outcomes when women took Vumerity at any point during pregnancy. These outcomes will be compared not only to the groups mentioned above but also to women who took a similar MS medication called dimethyl fumarate, and even to women without MS from the general population. This broad comparison helps paint a clearer picture of Vumerity's effects and is vital for providing good care for expectant mothers with MS.