Dimethyl fumarate

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Gold, 2015 Worldwilde
Until June 2014
Pregnancies that occurred during the dimethyl fumarate (DMF) clinical development program (including healthy controls and patients with MS, with exposure to placebo, DMF, or glatiramer acetate (GA)). Pregnancies exposed to dimethyl fumarate (DMF). unexposed, sick
Pregnancies exposed to placebo.
42 / 13 Only data related to clinical trials was used in this meta-analysis, in order to have a control group.
Nguyen (control exposed to IFN), 2019 International
2005 - 2016
Women of child-bearing age (15–45 years inclusive), prospectively enrolled in MSBase with a diagnosis of relapsing-remitting MS (RRMS). Pregnancies occurring during dimethyl fumarate therapy. (This is a subgroup of exposure among the exposed group considered in the study). exposed to other treatment, sick
Pregnancies occurring during Interferon beta (all) therapy. (This is a subgroup of exposure among the exposed group considered in the study).
17 / 350
Nguyen (control unexposed, sick), 2019 International
2005 - 2016
Women of child-bearing age (15–45 years inclusive), prospectively enrolled in MSBase with a diagnosis of relapsing-remitting MS (RRMS). Pregnancies occurring during dimethyl fumarate therapy. (This is a subgroup of exposure among the exposed group considered in the study). unexposed, sick
Pregnancies not exposed to disease-modifying therapies (DMTs) (pregnancy occurring within a year of DMT discontinuation or without DMT exposure in the prior year).
17 / 886

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk

master protocol