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15 January 2018

Cimzia - Biologic Treatment Suitable for Pregnant or Breastfeeding Women

Cimzia (Certolizumab Pegol) can now be used during pregnancy and whilst breastfeeding.

A ‘label change’ has been approved for Cimzia (also known by its generic name, Certolizumab Pegol), making it the first anti-TNF (a class of biologic treatment) that can be used in women who have active psoriatic arthritis, rheumatoid arthritis or ankylosing spondylitis, and are also pregnant or breastfeeding.

Until now, it has been common practice to recommend that women do not become pregnant whilst taking biologic treatments, and treatment is usually stopped if a woman taking a biologic does become pregnant, or wishes to start trying to conceive. This can result in a flare of the woman’s psoriatic arthritis, meaning that all too often women have a difficult choice to make between their health and mobility, and the opportunity to have children.

Consultant Rheumatologist, Dr Martin Lee, from Newcastle upon Tyne Hospitals NHS Foundation Trust said,

“Women in the UK suffering from moderate to severe active rheumatoid arthritis, active psoriatic arthritis and ankylosing spondylitis will now have an option that enables them to manage their condition effectively during pregnancy and in the longer-term. Currently some pregnant women in the UK stop taking their anti-TNF treatment during pregnancy. It is important for mothers to manage their condition in order to support the good health of both the mother and baby. The availability of a treatment option that can be taken during pregnancy enables women to protect their health, as well as their babies and is an important milestone in the treatment of immunological conditions.”

The manufacturer of Cimzia, UCB, has been studying how biologic drugs impact women of childbearing age. They state:

"Two key areas of focus are the transfer of a biologic drug through the placenta to the fetus and via the mother’s breast milk to the infant. Based on results from the landmark CRIB study, there is no to minimal placental transfer evident from mother to child during pregnancy and data from CRADLE, the prospective pharmacokinetic trial measuring the presence of an anti-TNF in breast milk, found minimal transfer of CIMZIA® during lactation. The findings from these two first-of-their-kind studies present strong implications for this patient population."

This is good news for women of childbearing age with psoriatic arthritis, and we hope that research in this area continues to develop and produce further appropriate treatment options. You should always speak to your doctor before stopping your treatment, and before becoming pregnant or breastfeeding whilst taking any treatment.

For more information on Cimzia, or the CRIB or CRADLE trials, please contact UCB.