Interferon beta 1b (IFN-β1b)

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Colvin (IFN beta-1b only), 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 (not otherwise specified)
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 (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 (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

See the method used to produce these results