Table 3.
Major congenital malformations in live‐born infants from prospectively reported pregnancies and timing of maternal CZP exposurea
| Infant abnormality | Mother's indication for CZP use | CZP exposure | ||
|---|---|---|---|---|
| First trimester | Second trimester | Third trimester | ||
| Accessory auricle | RA | X | X | X |
| Anal fistula | RA | X | – | – |
| Congenital heart diseaseb | RA | – | X | X |
| Polydactyly | RA | X | X | X |
| Cerebral ventricle dilatationb | Axial SpA | – | – | X |
| Talipes | CD | X | – | – |
| Vesicoureteric reflux | CD | X | X | – |
| Hydronephrosis | CD | – | – | X |
a
A total of 452 pregnancies resulted in live births. CZP = certolizumab pegol; RA = rheumatoid arthritis; SpA = spondyloarthritis; CD = Crohn's disease.
b
Premature birth.