Fingolimod - Medication and Pregnancy KB

Fingolimod

Exposed non-exposed, cohort studies

Study	Country Study period Study design	Data source	Exposure definition	Non-exposure definition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Karlsson (control exposed to IFN) 2014	Worldwide Until 2011 retrospective cohort	9 clinical studies in the fingolimod clinical development program.	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.	1st trimester	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 exposed to IFN) 2014	Worldwide Until 2011 retrospective cohort		Patients received treatment provided by the investigator in clinical trial.		1st trimester	66 / 4
Karlsson (control unexposed, sick) 2014	Worldwide Until 2011 retrospective cohort	9 clinical studies in the fingolimod clinical development program.	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.	1st trimester	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.
Karlsson (control unexposed, sick) 2014	Worldwide Until 2011 retrospective cohort		Patients received treatment provided by the investigator in clinical trial.		1st trimester	66 / 11
Nguyen (control exposed to IFN) 2019	International 2005 - 2016 prospective cohort	The Multiple Sclerosis (MS) Base Registry is a large, international observational cohort study, with long-term prospectively collected data.	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).	during pregnancy (anytime or not specified)	21 / 350
Nguyen (control exposed to IFN) 2019	International 2005 - 2016 prospective cohort		Data in the MSBase registry, including prospective pregnancy data, is entered in real time or near real time, as part of routine clinical visits. Information collected included: disease-modifying therapies exposure before and during pregnancy.		during pregnancy (anytime or not specified)	21 / 350
Nguyen (control unexposed, sick) 2019	International 2005 - 2016 prospective cohort	The Multiple Sclerosis (MS) Base Registry is a large, international observational cohort study, with long-term prospectively collected data.	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).	during pregnancy (anytime or not specified)	21 / 886
Nguyen (control unexposed, sick) 2019	International 2005 - 2016 prospective cohort		Data in the MSBase registry, including prospective pregnancy data, is entered in real time or near real time, as part of routine clinical visits. Information collected included: disease-modifying therapies exposure before and during pregnancy.		during pregnancy (anytime or not specified)	21 / 886
Pauliat 2020	Germany, Switzerland, Israel, France, Spain, Turkey, Australia 2000 - 2017 prospective cohort	Eight participating Teratology Information Services (TIS) and nine pharmacovigilance centers.	Pregnant women having used fingolimod during the first trimester.	exposed to other treatment, sick Pregnant women having used IFN-beta during the first trimester.	1st 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.
Pauliat 2020			Maternal information on medication exposure (indication, timing in pregnancy, duration, dose and concomitant medication) were collected at initial contact.		1st trimester	63 / 62

Case-control studies

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

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

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