Certolizumab pegol may be tolerated during pregnancy
Although most available data are limited to the first trimester, recently presented findings indicate that exposure to certolizumab during pregnancy by patients with rheumatic and other diseases does not adversely affect pregnancy outcomes.
Researchers identified 256 pregnancies with exposure to certolizumab pegol (Cimzia, UCB) and known outcomes from the UCB Pharma safety database. The pregnancies included 207 live births (80.9%), 26 miscarriages (10.2%), 22 induced abortions (8.6%) and one stillbirth (0.4%).
Rheumatic diseases accounted for 39.1% of indications for use of the drug. The mean maternal age at delivery was 31.3 years and 54.7% of patients had Crohn’s disease. Patients enrolled in clinical trials accounted for 9.1% of included patients.
Exposure to certolizumab pegol occurred only in the first trimester in 70 patients (44.6%), while 52 patients were exposed to the medication during all trimesters. Investigators found nine cases of congenital malformations among 210 infants, including three sets of twins. However, investigators discovered no similarities among the malformations.
“A limitation of this study is that the majority of the data originated from spontaneous post-marketing reports, which can be affected by bias and inherent limitations due to the passive and voluntary nature of the reporting systems,” the researchers wrote, and added that the data suggest in utero exposure to certolizumab pegol does not affect pregnancy outcomes. - by Shirley Pulawski
Clowse MEB, et al. Paper #2523. Presented at: American College of Rheumatology Annual Meeting; Nov. 7-11, 2015; San Francisco.
Disclosure: Clowse reports a financial relationship with UCB Pharma. Please see the full study for a list of all other authors’ relevant financial disclosures.