Fingolimod

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Karlsson (control exposed to IFN), 2014 Worldwide
Until 2011
Multiple sclerosis (MS) pregnant women reported from 9 clinical studies in patients with relapsing MS. Fingolimod treatment at the time of conception or within 6 weeks prior to conception. exposed to other treatment, sick
Interferon beta-1a treatment at the time of conception or within 6 weeks prior to conception.
66 / 4 Malformations: Numeratos: addition of anomalies in newborn and ETOP; Denominators: newborn and fetus with available information. The duration of in utero fingolimod exposure in the majority of live births was estimated to be >8 weeks to <=12 weeks.
Karlsson (control unexposed, sick), 2014 Worldwide
Until 2011
Multiple sclerosis (MS) pregnant women reported from 9 clinical studies in patients with relapsing MS. Fingolimod treatment at the time of conception or within 6 weeks prior to conception. unexposed, sick
Placebo treatment at the time of conception or within 6 weeks prior to conception.
66 / 11 Malformations: Numeratos: addition of anomalies in newborn and ETOP; Denominators: newborn and fetus with available information. The duration of in utero fingolimod exposure in the majority of live births was estimated to be >8 weeks to <=12 weeks.
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 Fingolimod 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).
21 / 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 Fingolimod 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).
21 / 886
Pauliat, 2020 Germany, Switzerland, Israel, France, Spain, Turkey, Australia
2000 - 2017
Pregnant women seeking information at a Teratology Information Service, themselves or through their physician. Pregnant women having used fingolimod during the first trimester. exposed to other treatment, sick
Pregnant women having used IFN-beta during the first trimester.
63 / 62 Fingolimod was discontinued at a median gestational age of 6 weeks (IQR 5-7, min 3, max 19). Exclusion criteria for both groups included exposure during pregnancy to any known major teratogen or fetotoxicant and to any treatment for malignancy.

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk

See the method used to produce these results