The European Medicines Agency has approved the label change for UCB’s Cimzia, making it the first anti-TNF for potential use in women with moderate-to-severe active rheumatoid arthritis, active psoriatic arthritis and ankylosing spondylitis during pregnancy and breastfeeding.
Active disease in pregnancy can have an impact on the health of both the mother and infant, including an increased risk of miscarriage, preterm delivery and the infant being small for gestational age -11. Adequate disease control therefore helps to ensure the best foetal and maternal health.
Disease activity may spontaneously improve during pregnancy, however approximately 50% of women with moderate-to-severe active rheumatoid arthritis, active psoriatic arthritis and ankylosing spondylitis need effective treatment and will have questions regarding the impact of active disease on their baby and the safety of different therapies during their pregnancy.
Additionally, women who are considering breastfeeding, along with their treating physicians, often face a choice between the risks of maternal medications needed for postpartum disease control and the optimal nutritional health of the child.
The approval is based on data from the post marketing CRIB1 and CRADLE2 studies as well as our pregnancy outcomes data.
The studies included women with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and Crohn’s Disease. In the EU, CIMZIA is not indicated in CD.