Natalizumab - Medication and Pregnancy KB

Natalizumab

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	Risk of bias
Ebrahimi (control unexposed, disease free) 2015	Germany 2006 - 2013 prospective cohort	A nationwide German independent pregnancy registry for Multiple Sclerosis (MS) and Motherisk (control groups)	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).	3 months or more before pregnancy or1st trimester	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, disease free) 2015	Germany 2006 - 2013 prospective cohort		Pregnant women registered to this database are followed prospectively either through telephone interviews every three months, or by visits to the university-based outpatient clinic. All self-reported data are collected through standardized questionnaires.		3 months or more before pregnancy or1st trimester	102 / 98
Ebrahimi (control unexposed, sick) 2015	Germany 2006 - 2013 prospective cohort	A nationwide German independent pregnancy registry for Multiple Sclerosis (MS) and Motherisk (control groups)	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.	3 months or more before pregnancy or1st trimester	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).'
Ebrahimi (control unexposed, sick) 2015	Germany 2006 - 2013 prospective cohort		Pregnant women registered to this database are followed prospectively either through telephone interviews every three months, or by visits to the university-based outpatient clinic. All self-reported data are collected through standardized questionnaires.		3 months or more before pregnancy or1st trimester	102 / 95
Nguyen (control exposed to IFN) 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 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).	during pregnancy (anytime or not specified)	104 / 350
Nguyen (control exposed to IFN) 2019	International 2005 - 2016 prospective cohort		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.		during pregnancy (anytime or not specified)	104 / 350
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 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).	during pregnancy (anytime or not specified)	104 / 886
Nguyen (control unexposed, sick) 2019	International 2005 - 2016 prospective cohort		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.		during pregnancy (anytime or not specified)	104 / 886
Portaccio (control exposed to IFN) 2018	Italy 2009 - 2015 prospective cohort	The MS Study Group of the Italian Neurological Society: 19 participating sites representing the main Italian Multiple sclerosis (MS) Centers.	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.	early pregnancy	69 / 341
Portaccio (control exposed to IFN) 2018	Italy 2009 - 2015 prospective cohort		All the patients were regularly followed up every 6 months and in the case of relapse.		early pregnancy	69 / 341
Portaccio (control unexposed, sick) 2018	Italy 2009 - 2015 prospective cohort	The MS Study Group of the Italian Neurological Society: 19 participating sites representing the main Italian Multiple sclerosis (MS) Centers.	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.	early pregnancy	69 / 341
Portaccio (control unexposed, sick) 2018	Italy 2009 - 2015 prospective cohort		All the patients were regularly followed up every 6 months and in the case of relapse.		early pregnancy	69 / 341

Case-control studies

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

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

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

master protocol