There was minimal to no transfer of Cimzia from nursing mothers to breast milk, considered to be an acceptable range for breast-feeding, according to a poster presentation at the American Academy of Dermatology Annual Meeting in Orlando, Florida.
“It is well-recognized that women with chronic inflammatory diseases face uncertainty during motherhood, given the lack of information on use of therapies that can control their symptoms during breast-feeding,” researcher Megan E.B. Clowse, MD, of Duke University Medical Center, Durham, North Carolina, stated in a news release from UCB.
“The rigorous design of this ambitious study sought to evaluate whether or not continuation of Cimzia (certolizumab pegol, UCB) treatment is compatible with breast-feeding. These results can help health care providers who need to advise their postpartum patients who are taking [certoliuzumab pegol] and want to breast-feed.”
The study’s objective was to determine the concentration of certolizumab pegol in human breast milk and to calculate the average daily infant dose, an estimation of the dose of maternal certolizumab pegol injected by the infant every day, according to the release.
The researchers used immunoassay to evaluate breast milk samples from 17 lactating mothers (mean age, 33.7 years) diagnosed with rheumatoid arthritis (n = 7), Crohn’s disease (n = 5), psoriatic arthritis (n = 3) and axial spondyloarthritis/ankylosing spondylitis (n =2). The women were at least 6 weeks postpartum and had been receiving certolizumab pegol prior to beginning the study and were currently on a maintenance dose.
The researchers used and ELISA immunoassay, with the lowest level of quantification (LLQ) being 10 times more sensitive than prior ELISA assays for studies of certolizumab pegol, to analyze the drug’s concentration in breast milk. They found that 56% of the samples were below the LLQ, with the remainder having a maximum certolizumab pegol concentration in breast milk of less than 10% of expected plasma of a therapeutic maintenance dose in an adult, which indicated minimal to no transfer of certolizumab from plasma to breast milk, according to the release.
The researchers concluded that the certolizumab pegol average daily infant dose (0 to 0.0104 mg/kg/day) is minimal, with the median certolizumab pegol relative infant dose is considered be in the safe range for breastfeeding.
Adverse events in mothers exposed to certolizumab pegol were consistent with known safety profile of the drug, with infants of mothers exposed to certolizumab pegol had adverse events that were consistent with what would be expected to unexposed infants of a similar age, the researchers concluded.
Clowse MEB, et al. Evaluating Transfer of Certolizumab Pegol into Breast Milk: Results from a Prospecting, Postmarketing, Multicenter Pharmacokinetic Study. Presented at: American Academy of Dermatology Annual Meeting; March 3-7, Orlando, Fla.
Disclosure: Clowse reports research support from Pfizer and Janssen and being a consultant form UCB Pharma.