Table 3.

Description of congenital malformations.

AbnormalityReport TypeRegionStudy TypeIndication for CZP Use
Left sided vesico-ureteric refluxProspectiveAfricaOpen-label extensionCD
Club footProspectiveNorth AmericaNoninterventional studyCD
22Q11.2 deletion syndrome, unilateral right kidney, hypospadias, and inguinal herniaProspectiveNorth AmericaClinical trialCD
Pyloric stenosisProspectiveNorth AmericaClinical trialCD
Posterior ankyloglossiaProspectiveNorth AmericaSpontaneousCD
Polydactyl, left hand, pinky sideProspectiveNorth AmericaSpontaneousRA
Renal cyst, no treatment requiredProspectiveNorth AmericaClinical trialRA
Anal fistulaProspectiveEuropeSpontaneousRA
Cleft palateRetrospectiveNorth AmericaSpontaneousCD
Congenital diaphragmatic herniaRetrospectiveNorth AmericaSpontaneousCD
Congenital morbus hirschsprung and club feetRetrospectiveEuropeSpontaneousRA
Right aortic arch with aberrant left subclavianRetrospectiveEuropeSpontaneousRA

  • CZP: certolizumab pegol; CD: Crohn disease; RA: rheumatoid arthritis.