FDA-Approved Label Change for Cimzia Important for Childbearing Women with Inflammatory Diseases

The U.S. Food and Drug Administration approved a label update stating there is negligible to low transfer of UCB’s Cimzia (certolizumab pegol) through the placenta and minimal transfer in breast milk from mother to infant.

This information will assist healthcare providers in providing care to women with chronic inflammatory diseases, including ankylosing spondylitis, during their reproductive years.

“The label change for [Cimzia] is important for women and their treating physicians to make informed decisions to manage their condition along their pregnancy journey. During this significant time in their lives, we’re proud to offer support and important treatment information to women and their physicians as they plan for pregnancy and adequate disease management.” Emmanuel Caeymaex, head of immunology and executive vice president of the Immunology Patient Value Unit at UCB, said in a press release.

About 45 percent of U.S. patients with inflammatory diseases such as ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease are women ages 18 to 45. Research in rheumatoid arthritis and Crohn’s has shown that active disease during pregnancy may lead to an increased risk of miscarriage, complications during the third trimester and birth, greater risk of preterm delivery, and infants small for their gestational age.

Faced with difficult questions regarding the impact of disease flares on themselves and their babies, mothers require more information on possible treatments. In particular, because of the high risk of postpartum flares, women considering breastfeeding, along with their physicians, need to balance the benefits of breastfeeding against the risks of maternal medications.

Cimzia is an antibody fragment against tumor necrosis factor (TNF)-alpha, a crucial pro-inflammatory molecule. Among other uses, the medication is indicated for the treatment of adults with active ankylosing spondylitis, rheumatoid arthritis, and psoriatic arthritis.

However, mothers and healthcare professionals still need more data on the potential link between using Cimzia and major birth defects or other adverse pregnancy outcomes, particularly the potential transfer of the medication via the placenta to the fetus or through the mother’s breast milk to the infant.

To address this, UCB conducted two studies that provided valuable information on these topics. The Phase 1 CRIB study (NCT02019602) showed a minimal to low placental transfer of Cimzia during pregnancy.

Scientists followed 16 women at least 30 weeks pregnant who were taking Cimzia at approved doses. Results revealed that blood levels of Cimzia were below the lower limit of detection in 13 out of 15 infants at birth and in all 15 infants at weeks four and eight. No anti-Cimzia antibodies were detected in mothers, umbilical cords, or infants.

One serious adverse reaction — an increased white blood cell count — was found in a newborn, who was treated with intravenous antibiotics.

In turn, the CRADLE Phase 1 study (NCT02154425) demonstrated minimal transfer of Cimzia during lactation. Out of 137 breast milk samples from 17 mothers, 56% had no detectable Cimzia, while the remaining samples showed minimal levels of the medication.

No serious adverse events were reported in any infant, while adverse reactions in the mothers were in line with known side effects of Cimzia.

These positive results in women with ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease supported the FDA-approved label change for Cimzia.

“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. Many women with chronic inflammatory disease discontinue their biologic treatment during pregnancy, often when they need disease control the most,” said Megan E. B. Clowse, MD, CRADLE’s lead author. “These data for [Cimzia] provide important information to empower women and healthcare providers making decisions about treatment during pregnancy and breastfeeding.”