Interferon beta (IFN-β)

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Boskovic (control unexposed, disease free), 2005 Canada
1997 - 2004
Pregnant women who contacted the Motherisk Program regarding Exposure during pregnancy. Pregnancies exposed to beta interferon. unexposed, disease free
Pregnancies of women counseled for on the treatment of Nausea and Vomiting (NVP) symptoms.
23 / 20 'In 21 gestations (all with MS) interferon therapy was terminated during the first trimester of pregnancy.'
Boskovic (control unexposed, sick), 2005 Canada
1997 - 2004
Pregnant women who contacted the Motherisk Program regarding Exposure during pregnancy. Pregnancies exposed to beta interferon. unexposed, sick
Pregnancies of women that discontinued beta interferon or Copaxone prior to conception.
23 / 21 'In 21 gestations (all with MS) interferon therapy was terminated during the first trimester of pregnancy.'
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.
Finkelsztejn (control exposed to Glatiramer), 2011 Brazil
2008 - ?
Patients attending regular consultations with their neurologists. Early exposure to beta interferon during pregnancy (This is a subgroup of exposure among the exposed group considered in the study). exposed to other treatment, sick
Early exposure to glatiramer acetate during pregnancy (This is a subgroup of exposure among the exposed group considered in the study).
69 / 20 Fragoso 2009 was updated by Finkelsztejn 2011.
Finkelsztejn (control unexposed, sick), 2011 Brazil
2008 - ?
Patients attending regular consultations with their neurologists. Early exposure to beta interferon during pregnancy (This is a subgroup of exposure among the exposed group considered in the study). unexposed, sick
No exposure to MS medications during pregnancy.
69 / 43 Fragoso 2009 was updated by Finkelsztejn 2011.
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 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).
39 / 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 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.
39 / 95 'Patients who were receiving any other medication that might influence the results were excluded.'
Fragoso b (control exposed to Glatiramer), 2013 Brazil, United Kingdom, Mexico and Argentina.
Not specified
Patients were included if they had at least one pregnancy with complete data after Multiple sclerosis (MS) had been diagnosed. MS patients with a minimum of eight weeks of continuous exposure to Interferon beta at the start of pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). exposed to other treatment, sick
MS patients with a minimum of eight weeks of continuous exposure to Glatiramer acetate at the start of pregnancy. (This is a subgroup of exposure among the exposed group considered in the study).
17 / 41 'The mean duration of drug exposure during pregnancy was 18.4 ± 13.2 weeks (range = 8–40 weeks).'
Fragoso b (control unexposed, sick), 2013 Brazil, United Kingdom, Mexico and Argentina.
Not specified
Patients were included if they had at least one pregnancy with complete data after Multiple sclerosis (MS) had been diagnosed. MS patients with a minimum of eight weeks of continuous exposure to Interferon beta at the start of pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). unexposed, sick
MS patients with no exposure to any Disease Modifying Treatment for a minimum of three months prior to pregnancy.
17 / 89 'The mean duration of drug exposure during pregnancy was 18.4 ± 13.2 weeks (range = 8–40 weeks).'
Giannini (control exposed to Glatiramer), 2012 Italy
2002 - 2008
All pregnancies beginning in MS patients diagnosed according to Mac-Donald’s criteria and referred to the participating centers were identified and tracked over the whole gestational period. Pregnancies in patients who had discontinued the Interferon beta less than four weeks from conception. exposed to other treatment, sick
Pregnancies in patients who had discontinued the Glatiramer acetate less than four weeks from conception.
88 / 17
Giannini (control unexposed, sick), 2012 Italy
2002 - 2008
All pregnancies beginning in MS patients diagnosed according to Mac-Donald’s criteria and referred to the participating centers were identified and tracked over the whole gestational period. Pregnancies in patients who had discontinued the Interferon beta less than four weeks from conception. unexposed, sick
Pregnancies in patients who had discontinued the Glatiramer acetate at least four weeks from the conception or who had never been treated with DMTs.
88 / 318
Lu (control exposed to Glatiramer), 2012 Canada
1998 - 2009
Multiple sclerosis (MS) patients with pregnancies exposed and unexposed to a disease-modifying drug (DMD), specifically IFNβ or GA. Births to women with RRMS exposed to Interferon beta within 1 month prior to conception and/or during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). exposed to other treatment, sick
Births to women with RRMS exposed to Glatiramer acetate within 1 month prior to conception and/or during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study).
15 / 6
Lu (control unexposed, sick), 2012 Canada
1998 - 2009
Multiple sclerosis (MS) patients with pregnancies exposed and unexposed to a disease-modifying drug (DMD), specifically IFNβ or GA Births to women with RRMS exposed to Interferon beta within 1 month prior to conception and/or during pregnancy. (This is a subgroup of exposure among the exposed group considered in the study). unexposed, sick
Births to women with RRMS who were DMD naïve (no exposure to a DMD disease-modifying drug (GA or IFNb) before or during pregnancy) or who were previously treated (used a DMD before pregnancy, but discontinued treatment at least one month prior to conception).
15 / 397 ADDITION of the two unexposed sick control groups (used a DMD before pregnancy, but discontinued treatment at least one month prior to conception AND DMD naïve).
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 (all) 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).
350 / 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 (all) 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).
350 / 886
Portaccio, 2018 Italy
2002 - 2008
All pregnancies beginning in MS patients diagnosed according to Mac-Donald’s criteria and referred to the participating centers were identified and tracked over the whole gestational period. Pregnancies in MS patients who had discontinued the Interferon beta less than four weeks from conception. unexposed, sick
Pregnancies in MS patients who had discontinued the DMT before the conception or who had never been treated with DMTs.
88 / 318
Thiel (unexposed, sick), 2016 Germany
2008 - 2013
Pregnant women who with relapsing-remitting Multiple sclerosis (MS) responded to advertisements or actively recruited after referral by their treating clinicians or MS nurses. IFN-beta-exposed pregnancies were defined as last injection administered after the last menstrual period (LMP). unexposed, sick
Pregnant women unexposed to disease-modifying therapies (never treated with DMTs or stop 0-4 months before pregnancy according to the DMT).
251 / 194 ' The vast majority (n = 246; 98.01%) of IFN- beta-exposed patients stopped treatment during the first trimester of pregnancy, mostly (n=179, 71%) with the detection of pregnancy before gw 6.'
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-β 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).
69 / 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-β 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.
69 / 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-β 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.
69 / 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

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