Interferon beta 1b (IFN-β1b)

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 Overall risk of bias
Colvin (IFN beta-1b only)
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 (not otherwise specified)
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. NA
The national Pharmaceutical Benefits Scheme, with around 80% of prescriptions dispensed in Australia.
Fragoso (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.' NA
Data were obtained from the medical records of patients attending regular consultations with their neurologists.
Fragoso (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.' NA
Data were obtained from the medical records of patients attending regular consultations with their neurologists.
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 NA
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.
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 NA
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.
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' NA
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.
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' NA
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.
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' NA
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.

Case-control studies

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

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

See the method used to produce these results