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

Interferon beta 1b (IFN-beta1b)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Colvin, 2010	Australia 2002 - 2005	All birth events in Western Australia (WA).	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).	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.
Fragoso a (control exposed to Glatiramer), 2013	Brazil Not specified	Children born from mothers with MS.	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).	10 / 39	'Patients who were receiving any other medication that might influence the results were excluded.'
Fragoso a (control unexposed, sick), 2013	Brazil Not specified	Children born from mothers with MS.	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.	10 / 95	'Patients who were receiving any other medication that might influence the results were excluded.'
Nguyen (control exposed to Glatiramer), 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 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).	61 / 137
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 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).	61 / 886
Weber-Schoendorfer (control exposed to Glatiramer), 2009	Germany 1996 - 2007	Pregnant women or their physicians who called the service for risk assessment in regard to exposure to medicines during pregnancy.	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).	21 / 31	'The main point of interest was the rate of major birth defects'
Weber-Schoendorfer (control unexposed, disease free), 2009	Germany 1996 - 2007	Pregnant women or their physicians who called the service for risk assessment in regard to exposure to medicines during pregnancy.	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.	21 / 1556	'The main point of interest was the rate of major birth defects'
Weber-Schoendorfer (control unexposed, sick), 2009	Germany 1996 - 2007	Pregnant women or their physicians who called the service for risk assessment in regard to exposure to medicines during pregnancy.	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.	21 / 64	'The main point of interest was the rate of major birth defects'

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

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

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