FDA Label Update for Certolizumab Pegol Affects Women of Childbearing Age

The FDA has approved a label update to include pharmacokinetic data showing low transfer of certolizumab pegol through placenta and minimal transfer to breast milk from mother to infant.

The US Food and Drug Administration (FDA) has approved a label update to include pharmacokinetic data showing low transfer of CIMZIA® (certolizumab pegol) through the placenta and minimal transfer to breast milk from mother to infant.1

The updated data include essential information that will help healthcare providers inform women with chronic inflammatory diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and Crohn disease through their reproductive period.

Recent data has suggested that the consequences of active disease during pregnancy can have serious implications for both mother and infant, including increased risk for miscarriage,2 difficulties during the third trimester, and an increased risk for preterm delivery. UCB, the manufacturer of CIMZIA, notes that the label change will allow women and their physicians to make informed decisions to manage chronic inflammatory diseases throughout their childbearing years.

The label change was approved based on data from the CRIB and CRADLE studies. The CRIB study (ClinicalTrials.gov Identifier: NCT02019602) found that there is negligible to low transfer of certolizumab pegol through the placenta from mother to child during pregnancy. In addition, data from the prospective pharmacokinetic CRADLE trial (ClinicalTrials.gov Identifier: NCT02154425) show that there is minimal transfer of certolizumab pegol from mother to infant during lactation. Both studies included women with RA, AS, PsA, and Crohn disease.

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“It is well recognized that women with chronic inflammatory disease face uncertainty during motherhood, given the lack of information on treatment during pregnancy and breastfeeding,” stated Megan E. B. Clowse, MD, MPH, Duke University Medical Center, lead author of the CRADLE study. “Many women with chronic inflammatory disease discontinue their biologic treatment during pregnancy, often when they need disease control the most. These data for CIMZIA provide important information to empower women and healthcare providers making decisions about treatment during pregnancy and breastfeeding.”


  1. CIMZIA® (certolizumab pegol) label update marks major advance for women of childbearing age with chronic inflammatory disease in the U.S. [press release]. Brussels, Belgium: UCB. https://www.ucb.com/stories-media/Press-Releases/article/CIMZIA-certolizumab-pegol-label-update-marks-major-advance-for-women-of-childbearing-age-with-chronic-inflammatory-disease-in-the-U-S. Published March 22, 2018. Accessed March 22, 2018.
  2. Brouwer J, Laven JS, Hazes JM, Dolhain RJ. Miscarriages in female rheumatoid arthritis patients: associations with serologic findings, disease activity, and antirheumatic drug treatment.  Arthritis Rheumatol. 2015;67(7):1738–43.