No Impact of Maternal Certolizumab Pegol Exposure on Pregnancy Outcomes

SAN DIEGO, CA—Updated analysis of pregnancy outcomes after exposure to certolizumab pegol supports previous reports suggesting no obvious or apparent impact of maternal exposures, according to data presented at the 2013 ACR/ARHP Annual Meeting.

Certolizumab pegol is a PEGylated Fc-free anti-TNF agent approved for the treatment of rheumatoid arthritis and Crohn’s disease. A previous retrospective pregnancy analysis reported to the UCB Pharma global safety database suggested pregnancy outcomes after maternal exposure to certolizumab pegol are similar to those reported for the general U.S. population—65% live births, 17% fetal losses, 18% elective terminations—based on 6,578,000 pregnancies from 1990 to 2008.

Megan E. B. Clowse, MD, MPH, of Duke University Medical Center, Durham, NC, and colleagues sought to provide an updated analysis of pregnancy outcomes after certolizumab pegol exposure that included new reports and ongoing pregnancies since the last analysis. Study authors retrospectively searched the UCB Pharma global safety database, including both clinical trial and post-marketing reports, through March 28, 2013.

The team examined the number of live births, spontaneous miscarriages, and elective terminations for neonates exposed to certolizumab pegol (via maternal and paternal exposure) before and during pregnancy. A total of 337 cases were reported, with 17 (5%) having occurred following paternal exposure and 320 (95%) having occurred following maternal exposure.

Of the 320 maternal exposure pregnancies, 234 were reported from the United States. Outcomes were unreported for 67 cases (20.9%) and known outcomes were available for 253 cases (79.1%): 191/253 (75.5%) resulted in live births, 37/253 (14.6%) in spontaneous miscarriages, and 25/253 (9.9%) women had elective terminations.

“Live births were reported for the majority of pregnancies with available outcomes following maternal certolizumab pegol exposure,” Dr. Clowse reported. “A greater proportion of miscarriages and elective terminations were recorded in clinical trial reports compared to spontaneous post-marketing reports.”

Reported maternal age range at delivery was similar for mothers with the common underlying conditions of rheumatoid arthritis (21.5-40.1 years; n=21 with available data), and Crohn’s disease (21.7-42.9 years; n=71 with available data).

Regardless of report source or underlying maternal indication for treatment with certolizumab pegol, neonatal characteristics were similar for all live birth reports after maternal exposure to the agent, with the majority reportedly full-term (≥37 weeks) and neonatal birthweight generally ≥2500g.

Four cases of congenital abnormality were reported in the 132 live births after maternal exposure during pregnancy; 1 infant had vesicoureteric reflux, 1 was born with congenital morbus Hirschsprung and club feet, 1 had right aortic arch with aberrant left subclavian artery, and 1 infant had mild, unilateral hydronephrosis on antenatal ultrasound and was described as healthy upon birth, Dr. Clowse stated. “A single neonatal death from brain damage and pneumoperitoneum was reported after material exposure in 1 of a set of twins delivered at 26 weeks of gestation; postnatal outcome of the other neonate is not known.”

“Prospective data from large numbers of pregnant women are required to fully evaluate the safety and tolerability of certolizumab pegol in pregnancy,” concluded Dr. Clowse.