Vedolizumab - Medication and Pregnancy KB

Vedolizumab

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
Moens (Controls exposed to TNFi) 2020	Europe 2009 - 2018 retrospective cohort	A retrospective multicentre (n = 29) observational study from nine countries (Belgium, Denmark, France, Germany, Ireland, Israel, Serbia, Sweden and The Netherlands).	Pregnancies exposed to Vedolizumab.	exposed to other treatment, sick Pregnancies exposed to anti‐TNF.	at least 1st trimester	79 / 186	Three (4%) women initiated VDZ treatment after conception.
Moens (Controls exposed to TNFi) 2020	Europe 2009 - 2018 retrospective cohort		Information from Vedolizumab pregnancies was collected through a structured electronic case report form (CRF) that had to be filled out by the treating gastroenterologist, including dose and duration of VDZ therapy, other IBD medications during pregnancy.		at least 1st trimester	79 / 186	Three (4%) women initiated VDZ treatment after conception.
Moens (Controls unexposed, sick) 2020	Europe 2009 - 2018 retrospective cohort	A retrospective multicentre (n = 29) observational study from nine countries (Belgium, Denmark, France, Germany, Ireland, Israel, Serbia, Sweden and The Netherlands).	Pregnancies exposed to Vedolizumab.	unexposed, sick Pregnancies that were not exposed to biologics nor to immunomodulatory drugs.	at least 1st trimester	79 / 184	Three (4%) women initiated VDZ treatment after conception.
Moens (Controls unexposed, sick) 2020	Europe 2009 - 2018 retrospective cohort		Information from Vedolizumab pregnancies was collected through a structured electronic case report form (CRF) that had to be filled out by the treating gastroenterologist, including dose and duration of VDZ therapy, other IBD medications during pregnancy.		at least 1st trimester	79 / 184	Three (4%) women initiated VDZ treatment after conception.

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