Cimzia Label Update Provides New Information for Women of Childbearing Age

Data added to the labeling includes first-of-their-kind pharmacokinetic studies demonstrating negligible to low transfer of CIMZIA through placenta and minimal transfer to breast milk from mother to infant.

UCB announced that the Food and Drug Administration (FDA) has approved an update to the Cimzia (certolizumab pegol) labeling to include new data regarding the transfer of drug through the placenta and breast milk from mother to infant.

Findings from the first-of-their-kind pharmacokinetic studies (CRIB and CRADLE) indicated negligible to low transfer of certolizumab pegol through the placenta as well as minimal transfer to breast milk. 

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CRIB evaluated the potential amount of placental transfer of certolizumab pegol from pregnant women to their infants (N=16); the study included women ≥30 weeks gestation who were already receiving certolizumab pegol. The data showed levels of the drug were below the lower limit of quantification (LLOQ 0.032µg/mL) in 13 out of 15 infant blood samples at birth. By Week 4 and Week 8, all infants had no detectable concentrations of the drug. The findings demonstrate negligible to low placental transfer of certolizumab pegol to infants, suggesting little in utero fetal exposure during the 3rd trimester.

CRADLE evaluated levels of certolizumab pegol in human breast milk to estimate the daily dose of maternal certolizumab pegol that the breastfeeding infant consumed. Of the 137 breast milk samples, 56% showed no measurable levels of certolizumab pegol and 44% showed minimal levels. The researchers estimated the average daily infant dose to be 0.0035mg/kg/day (range 0–0.01mg/kg/day). Based on measurable samples, 0.56%–4.25% of the maternal dose was estimated to reach the infant. 

With regard to major birth defects and other adverse outcomes, the Company stated that data from the ongoing pregnancy registry is limited and is therefore insufficient to make any conclusions on risk.

Cimzia, a PEGylated tumor necrosis factor (TNF) blocker, is currently indicated to treat adults with moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), and to reduce signs/symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. 

“These data for Cimzia provide important information to empower women and healthcare providers making decisions about treatment during pregnancy and breastfeeding,” said lead author Megan E. B. Clowse, MD, MPH, Duke University Medical Center.

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