'Minimal' placental transfer of certolizumab pegol found for pregnant women with rheumatic diseases

MADRID — Zero to minimal placental transfer of certolizumab pegol was discovered for a cohort of pregnant women with rheumatic diseases, according to findings presented at the EULAR Annual Congress.

“This is the first industry-sponsored study designed to evaluate level of placental transfer of [certolizumab pegol (Cimzia, UCB Pharma)] CZP from mother to infant using a specific assay,” Xavier Mariette, MD, PhD, said.

Mariette described the assay as highly sensitive in determining whether CZP levels were 0.032 μg/mL, which was the lower limit of quantification (LLOQ) used in the study.

“The sensitivity of this assay is 10-times higher than the classical assay for detecting serum CZP levels,” he said. “The assay is also specific.”

The data set included 16 women who entered the sampling period and 14 mother-infant pairs that met criteria for the final per-protocol analysis. At entry, eligible women had to be 30 weeks pregnant and treated with the study drug at a locally approved level as determined by a clinician independent of the study. Levels of the drug were assessed in the children at birth and at 4 weeks, and also in the umbilical cord blood.

Thirteen of 14 babies did not have CZP in their blood at the time of delivery. One infant had a level of 0.042 μg/ml. This was reported in the mother with the highest concentration of the drug, at 49.4 μg/ml.

Among 15 umbilical cords, three showed low levels of the drug. Other findings indicated there were no anti-CZP antibodies detected at any point during the study. Safety data showed serious adverse events in two infants.

“There was no safety signal observed in mothers or babies,” Mariette said.

Eleven of the 16 women had rheumatoid arthritis. Twelve women had taken CZP from the beginning of pregnancy. APGAR score was normal for all infants. The median dose of CZP among mothers was 24.5 μg /ml.

“We observed no to minimal placental transfer of CZP from mother to infant, suggesting a lack of in utero fetal exposure during the third trimester,” Mariette concluded. — by Rob Volansky

Reference:

Mariette X, et al. Abstract #OP0017. Presented at: EULAR Annual Congress; June 14-17, 2017; Madrid.

Disclosure: Mariette reports associations with Aurinia Pharmaceuticals.