Caftor - Medication and Pregnancy KB

Caftor

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
Chouchana (Controls unexposed, disease free) 2025	France 2018 - 2023 retrospective cohort (claims database)	The French health insurance data warehouse (SNDS, Système National des Données de Santé), which covers about 99 % of the French population.	Females with cystic fibrosis (fwCF) and at least one prescription of CFTR modulators, specifically elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) filled from one month in the preconception period until delivery.	unexposed, disease free Females not having cystic fibrosis (CF).	at least 1st trimester	148 / 3879601	Among 148 pregnancies, 136 were exposed during first trimester and treatment was maintained through whole pregnancy in 119 fwCF. (> 90%=> considered as at least T1).
Chouchana (Controls unexposed, disease free) 2025	France 2018 - 2023 retrospective cohort (claims database)		The French health insurance data warehouse (SNDS, Système National des Données de Santé), which comprises exhaustive data on patient health care expenditure such as dispensed drugs.		at least 1st trimester	148 / 3879601
Chouchana (Controls unexposed, sick) 2025	France 2018 - 2023 retrospective cohort (claims database)	The French health insurance data warehouse (SNDS, Système National des Données de Santé), which covers about 99 % of the French population.	Females with cystic fibrosis (fwCF) and at least one prescription of CFTR modulators, specifically elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) filled from one month in the preconception period until delivery.	unexposed, sick Females with cystic fibrosis (fwCF) and no prescription of CFTR modulators from one month in the preconception period until delivery.	at least 1st trimester	148 / 451	Among 148 pregnancies, 136 were exposed during first trimester and treatment was maintained through whole pregnancy in 119 fwCF. (> 90%=> considered as at least T1).
Chouchana (Controls unexposed, sick) 2025	France 2018 - 2023 retrospective cohort (claims database)		The French health insurance data warehouse (SNDS, Système National des Données de Santé), which comprises exhaustive data on patient health care expenditure such as dispensed drugs.		at least 1st trimester	148 / 451
Etherington (ETI) 2024	United Kingdom 2010 - 2023 retrospective cohort	Not specified.	Women with Cystic Fibrosis (wwCF) who became pregnant and continued elexacaftor/tezacaftor/ ivacaftor (ETI) during pregnancy.	unexposed, sick Women with Cystic Fibrosis (wwCF) who became pregnant during the pre modulator era.	at least 1st trimester, during pregnancy (anytime or not specified)	24 / 26
Etherington (ETI) 2024	United Kingdom 2010 - 2023 retrospective cohort	Not specified.	A retrospective review of prospectively collected data between 2010 and 2023. Data were obtained on modality of conception, baseline demographics, mode of delivery, lactation and maternal and foetal outcomes (no other details).			24 / 26
Jain 2025	USA 2010 - 2021 retrospective cohort	Multicenter, retrospective study was conducted at 11 US adult Cystic Fibrosis (CF) centers.	Female individuals with Cystic Fibrosis (fwCF) treated with CF transmembrane conductance regulator (CFTR) modulator during any trimester of pregnancy.	unexposed, sick Female individuals with Cystic Fibrosis (fwCF) not treated with CF transmembrane conductance regulator (CFTR) modulator during pregnancy.	during pregnancy (anytime or not specified)	114 / 193	Results reported here => Sum of highly effective modulator therapy (HEMT) including ivacaftor or elexacaftor/tezacaftor/ivacaftor; and other modulators including lumacaftor/ivacaftor and tezacaftor/ivacaftor.
Jain 2025	USA 2010 - 2021 retrospective cohort		Local electronic medical record data.		during pregnancy (anytime or not specified)	114 / 193
Salvatore 2026	Italia 2016 - 2023 retrospective cohort	Italian cystic fibrosis registry (from 27 Italian cystic fibrosis centers).	Women with cystic fibrosis (WwCF) on CF transmembrane conductance regulator protein modulators (CFTRm) therapy during pregnancy.	unexposed, sick Women with cystic fibrosis (WwCF) not on CF transmembrane conductance regulator protein modulators (CFTRm) during pregnancy.	throughout pregnancy	46 / 98	In all exposed women: 42 continued throughout pregnancy and 4 suspended during the first trimester => > 90% Throughout pregnancy. 55 women were on CFTR modulator therapy before pregnancy: 45 ETI, 7 Ivacaftor, 2 Lumacaftor/Ivacaftor, 1 not specified.
Salvatore 2026	Italia 2016 - 2023 retrospective cohort		Clinical data of women with cystic fibrosis (WwCF) with at least one pregnancy were retrospectively collected from the Italian CF Registry (ICFR), including CF transmembrane conductance regulator protein modulators (CFTRm) therapy during the year of conception.		throughout pregnancy	46 / 98

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.

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