Caftor - Medication and Pregnancy KB

Caftor

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Chouchana (Controls unexposed, disease free), 2025	France 2018 - 2023	All singleton pregnancies lasting ≥22 weeks of gestation (WG), linked with a childbirth stay allowing assessment of pregnancy outcomes, and carried out between January 2018 and December 2023.	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).	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, sick), 2025	France 2018 - 2023	All singleton pregnancies lasting ≥22 weeks of gestation (WG), linked with a childbirth stay allowing assessment of pregnancy outcomes, and carried out between January 2018 and December 2023.	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.	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).
Jain, 2025	USA 2010 - 2021	All female individuals with Cystic Fibrosis (fwCF) who reported conception from January 1, 2010, to June 30, 2021, and treated in one of the 11 participating US adult 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.	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.
Salvatore, 2026	Italia 2016 - 2023	Women with cystic fibrosis (WwCF) with at least one pregnancy over the 2016–2023 study period, registered in the from the Italian CF Registry (ICFR).	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.	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.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

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

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

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