FDA Approves Cimzia Label Update Essential for Childbearing Women with Inflammatory Diseases

FDA Approves Cimzia Label Update Essential for Childbearing Women with Inflammatory Diseases
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Cimzia

The U.S. Food and Drug Administration (FDA) recently approved UCB’s request for a label update for Cimzia (certolizumab pegol) indicating low transfer levels of the medication from mother to child through the placenta and breast milk.

The move marks an important advance in providing key information on the care of women with Crohn’s and other chronic inflammatory diseases throughout their reproductive years.

“Recognition and public support for the unique family planning needs of women with chronic inflammatory disease is crucial for this underserved population. 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,” Emmanuel Caeymaex, head of immunology and executive vice president of UCB’s immunology patient value unit, said in a press release.

Among other indications, Cimzia helps to reduce symptoms of Crohn’s disease and maintain clinical response in adults with moderate-to-severe disease who have had an inadequate response to conventional therapy.

Approval of the Cimzia label update is based on data from two studies: the Phase 1 CRIB study (NCT02019602) and the Phase 1 CRADLE study (NCT02154425), both of which are complete.

CRIB was designed to assess the potential level of placental transfer of Cimzia from pregnant women to their infants. The study followed 16 women who were at least 30 weeks pregnant and already receiving Cimzia at approved doses.

In 13 of 15 blood samples at birth, Cimzia levels were too low to measure. The same result was observed for all samples after the fourth and eighth weeks.

One child had a minimal level of Cimzia, 0.09% of the mother’s plasma concentration, at birth, and in another case, the baby, delivered by emergency Caesarean section, had 4.49% of the mother’s plasma concentration at birth, but after week four, all measurable concentration levels dissipated.

The second study, CRADLE, was designed to determine the concentration of Cimzia in human breast milk and to estimate the daily dose of the medication ingested by infants through the mother’s milk.

Of 137 breast milk samples from 17 mothers, 56% had no measurable Cimzia, and the remaining samples showed only minimal levels. The median of the average daily dose was estimated to be 0.0035 mg/kg/day. The percentage of the dose that reached an infant ranged from 0.56 to 4.25%.

Chronic inflammatory diseases like Crohn’s often affect women of childbearing age — approximately 17 percent of patients with chronic inflammatory diseases in the U.S. are women ages 18 to 45.

There is an ongoing pregnancy registry on use of Cimzia in pregnant women; however, the data available is still limited and insufficient to determine a risk of major birth defects or other adverse pregnancy outcomes.

Research has shown that having active disease during pregnancy can have serious consequences for both mother and child, including an increased risk of miscarriage, difficulties during pregnancy and at birth, and an increased risk of preterm delivery.

“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, lead author of the CRADLE study. “These data for Cimzia provide important information to empower women and healthcare providers making decisions about treatment during pregnancy and breastfeeding.”

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Carolina holds a BSc in Anthropology and a MSc in Urban Studies., and brings her interdisciplinary skills to her writing on a range of different topics in science, research and advocacy news.