Fingolimod - Medication and Pregnancy KB

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

Warning! There are no case-control studies available for this drug.

3 studies, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.

master protocol