CRIB Study Shows No Transplacental Transfer of Certolizumab Save

Mariette and colleagues have reported on the prospective pharmacokinetic study of placental transfer of certolizumab pegol (CZP) from pregnant women to their infants at the time of birith. They found no to minimal CZP in infant blood at the time of delivery, suggesting a lack of in utero fetal exposure during the third trimester.

They enrolled 16 women on CZP who were ≥30 weeks pregnant and had to receive the last dose ≤35 days of delivery.  At delivery blood samples were collected from mothers, umbilical cords and infants at delivery, and then again at 4 and 8 weeks post-partum in the infants.

Maternal CZP plasma levels at delivery were within the expected therapeutic range (median [range] 24.4 [5.0–49.4] μg/mL).

Two infants samples were excluded due to missing data at birth (1) and implausible PK data (1).

Of the remaining 14 infants, 13 had no measureable CZP levels at birth (0.032 μg/mL), and 1 had a minimal CZP level of 0.042 μg/mL.

No CZP was detected in the infants at weeks 4 and 8.  Of umbilical cord samples, 3/15 had quantifiable CZP levels (maximum 0.048 μg/mL).

These results support continuation of CZP treatment during pregnancy, when considered necessary.