Natalizumab

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Ebrahimi (control unexposed, disease free), 2015 Germany
2006 - 2013
Pregnant women included in the registry for Multiple Sclerosis (MS) and women who contacted the Motherisk. Outcomes of RRMS women accidentally exposed to natalizumab during pregnancy: treatment with natalizumab from eight weeks prior to the start of the last menstrual period (LMP) and onward. unexposed, disease free
Outcomes of pregnant women with no teratogenic exposures (who contacted the Motherisk general or nausea and vomiting of pregnancy (NVP) lines between 1997 and 2012).
102 / 98 'Exposure during pregnancy: 8 weeks prior to LMP (n=20), 0-9 weeks of gestation (n=76), 10–13 weeks of gestation (n=4), till the 31st week of pregnancy (n=1).' => Indexed as: '3 months (or more) before pregnancy and/or 1st trimester'.
Ebrahimi (control unexposed, sick), 2015 Germany
2006 - 2013
Pregnant women included in the registry for Multiple Sclerosis (MS) and women who contacted the Motherisk. Outcomes of RRMS women accidentally exposed to natalizumab during pregnancy: treatment with natalizumab from eight weeks prior to the start of the last menstrual period (LMP) and onward. unexposed, sick
Outcomes of pregnant women with confirmed RRMS who were recruited prospectively (by Motherisk program between 1997 and 2013), and were not treated with natalizumab.
102 / 95 'Control group: exposed to DMD in pregnancy: 25 (32%): 2 GLAT; 17 INFB-1a; 6 INFB-1.' 'Exposure during pregnancy: 8 weeks prior to LMP (n=20), 0-9 weeks of gestation (n=76), 10–13 weeks of gestation (n=4), till the 31st week of pregnancy (n=1).'
Nguyen (control exposed to IFN), 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 Natalizumab therapy. (This is a subgroup of exposure among the exposed group considered in the study). exposed to other treatment, sick
Pregnancies occurring during Interferon beta (all) therapy. (This is a subgroup of exposure among the exposed group considered in the study).
104 / 350
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 Natalizumab 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).
104 / 886
Portaccio (control exposed to IFN), 2018 Italy
2009 - 2015
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 natalizumab less than 8 weeks from conception. unexposed, sick
Pregnancies in MS patients who had discontinued the Interferon beta less than four weeks from conception.
69 / 341
Portaccio (control unexposed, sick), 2018 Italy
2009 - 2015
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 natalizumab less than 8 weeks from conception. unexposed, sick
Pregnancies in MS patients who had discontinued natalizumab (at least 8 weeks) or immunomodulatory injectable therapies prior to the last menstrual period; or who were never treated.
69 / 341

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk

See the method used to produce these results