Interferon beta 1b (IFN-beta1b) - Medication and Pregnancy KB

Interferon beta 1b (IFN-beta1b)

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
Colvin 2010	Australia 2002 - 2005 retrospective cohort (claims database)	Linkage between administrative records of medicines dispensed in pregnancy (Pharmaceutical Benefits Scheme (PBS) and health administrative data.	Interferon beta-1b dispensed from 14 days after the last menstrual period (LMP) to the end of first trimester or to the end of the pregnancy event. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) All other births (those births to women dispensed a Pharmaceutical Benefits Scheme (PBS) medicine or not).	1st trimester	7 / 106067	Category D or X medicines also studied. Total nb of unexposed: 106067=106 074-7. Birth defect: structural or functional abnormality. Most minor defects are not recorded in the BDR. Of all cases, about 90% have at least one major birth defect.
Colvin 2010			The national Pharmaceutical Benefits Scheme, with around 80% of prescriptions dispensed in Australia.		1st trimester	7 / 106067
Fragoso a (control exposed to Glatiramer) 2013	Brazil Not specified retrospective cohort	The Brazilian database of pregnancy and multiple sclerosis (MS), a well-established large national registry.	The drug-exposure group was considered to be at least 2 weeks of Interferon beta-1b use at any time after conception. (This is a subgroup of exposure among the exposed group considered in the study).	exposed to other treatment, sick The drug-exposure group was considered to be at least 2 weeks of Glatiramer acetate use at any time after conception. (This is a subgroup of exposure among the exposed group considered in the study).	during pregnancy (anytime or not specified)	10 / 39	'Patients who were receiving any other medication that might influence the results were excluded.'
Fragoso a (control exposed to Glatiramer) 2013	Brazil Not specified retrospective cohort		Data were obtained from the medical records of patients attending regular consultations with their neurologists.		during pregnancy (anytime or not specified)	10 / 39
Fragoso a (control unexposed, sick) 2013	Brazil Not specified retrospective cohort	The Brazilian database of pregnancy and multiple sclerosis (MS), a well-established large national registry.	The drug-exposure group was considered to be at least 2 weeks of Interferon beta-1b use at any time after conception. (This is a subgroup of exposure among the exposed group considered in the study).	unexposed, sick The control group consisted of women with MS who were not exposed to any drugs for at least 3 months prior to conception and remained unexposed at all times during pregnancy.	during pregnancy (anytime or not specified)	10 / 95	'Patients who were receiving any other medication that might influence the results were excluded.'
Fragoso a (control unexposed, sick) 2013	Brazil Not specified retrospective cohort		Data were obtained from the medical records of patients attending regular consultations with their neurologists.		during pregnancy (anytime or not specified)	10 / 95
Nguyen (control exposed to Glatiramer) 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 Interferon beta-1b therapy. (This is a subgroup of exposure among the exposed group considered in the study).	exposed to other treatment, sick Pregnancies occurring during Glatiramer acetate therapy. (This is a subgroup of exposure among the exposed group considered in the study).	during pregnancy (anytime or not specified)	61 / 137
Nguyen (control exposed to Glatiramer) 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)	61 / 137
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 Interferon beta-1b 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)	61 / 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)	61 / 886
Weber-Schoendorfer (control exposed to Glatiramer) 2009	Germany 1996 - 2007 prospective cohort	The Teratology Information Service (TIS), Berlin	Women exposed groups to Interferon-β1b during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study).	exposed to other treatment, sick Women exposed groups to Glatiramer acetate during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study).	at least 1st trimester	21 / 31	'The main point of interest was the rate of major birth defects'
Weber-Schoendorfer (control exposed to Glatiramer) 2009	Germany 1996 - 2007 prospective cohort	The Teratology Information Service (TIS), Berlin	A structured questionnaire administered to physicians or mothers for details of drug exposure (timing in pregnancy, dose, and duration) at the first contact during (early) pregnancy, before the pregnancy outcome was known.		at least 1st trimester	21 / 31
Weber-Schoendorfer (control unexposed, disease free) 2009	Germany 1996 - 2007 prospective cohort	The Teratology Information Service (TIS), Berlin	Women exposed groups to Interferon-β1b during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study).	unexposed, disease free Pregnant women who had been counseled during pregnancy after exposures known to be nonteratogenic.	at least 1st trimester	21 / 1556	'The main point of interest was the rate of major birth defects'
Weber-Schoendorfer (control unexposed, disease free) 2009	Germany 1996 - 2007 prospective cohort	The Teratology Information Service (TIS), Berlin	A structured questionnaire administered to physicians or mothers for details of drug exposure (timing in pregnancy, dose, and duration) at the first contact during (early) pregnancy, before the pregnancy outcome was known.		at least 1st trimester	21 / 1556
Weber-Schoendorfer (control unexposed, sick) 2009	Germany 1996 - 2007 prospective cohort	The Teratology Information Service (TIS), Berlin	Women exposed groups to Interferon-β1b during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study).	unexposed, sick Multiple sclerosis patients who neither had taken the immunomodulatory drugs under study nor were exposed to known teratogens such as classical anticonvulsants or phenprocoumon, although some members of this group were given glucocorticoids for a relapse.	at least 1st trimester	21 / 64	'The main point of interest was the rate of major birth defects'
Weber-Schoendorfer (control unexposed, sick) 2009	Germany 1996 - 2007 prospective cohort	The Teratology Information Service (TIS), Berlin	A structured questionnaire administered to physicians or mothers for details of drug exposure (timing in pregnancy, dose, and duration) at the first contact during (early) pregnancy, before the pregnancy outcome was known.		at least 1st trimester	21 / 64

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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