Study Investigates Transfer of TNFi Therapy to Breast Milk
A study which assessed concentrations of certolizumab pegol (Cimzia; UCB) in human breast milk found that minimal to no transfer of drug from plasma to breast milk occurs.
The study evaluated breast milk samples from 17 lactating mothers diagnosed with rheumatoid arthritis (n=7), Crohn's disease (n=5), psoriatic arthritis (n=3), and axial spondyloarthritis/ankylosing spondylitis (n=2), using a highly sensitive and specific immunoassay with a lowest level of quantification (LLQ) of 0.032ug/mL. Each participant was at least 6 weeks post-partum and was receiving certolizumab pegol (CZP) prior to entering the study.
Results showed that more than half of the samples (56%) were below the LLQ, while the remainder had a maximum CZP concentration of <1% of expected plasma of a therapeutic maintenance dose in an adult. A relative infant dose (RID) below 10% is considered unlikely to be of concern to infant well-being. The mean RID for Cimzia was calculated to be below 0.5% of the maternal dose and the median RID was 0.15%.
“These results can help healthcare providers who need to advise their post-partum female patients who are taking Cimzia and want to breast feed,” said lead study author Megan E. B. Clowse, MD, Duke University Medical Center.
Cimzia, an Fc-free, PEGylated anti-tumor necrosis factor, is indicated to treat adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. In addition, it is indicated for reducing signs and 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.
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