Natalizumab - Medication and Pregnancy KB

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

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

15 studies, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.

master protocol