Use of biologics during pre-conception, pregnancy & breastfeeding

The aim of this leaflet

This leaflet has been written to help you understand more about the use of biologic drugs or ‘biologics’ for the treatment of psoriasis when you want to become pregnant, if you are pregnant or breastfeeding. It tells you what needs to be considered regarding this treatment before, during and after your pregnancy and where you can find out more about it.

What is a biologic?

‘Biologics’ are drugs that are produced by living cells or bacteria. There are various “biologics” and some are very effective for the treatment of autoimmune or inflammatory diseases like rheumatoid arthritis, Crohn’s disease and (moderate-to-severe) psoriasis. For the treatment of psoriasis,
etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade) and ustekinumab (Stelara) are currently available in Europe. Biologics are either administered by injection or in a drip.

How does a biologic work?

In psoriasis the immune system produces far too many inflammatory proteins (cytokines) which cause the skin lesions. Biologic drugs specifically block or inhibit the activity of these inflammatory proteins
and interrupt the inflammatory process and may lead to an improvement of your psoriasis.

Can I use a biologic drug when I want to become pregnant?

Limited experience with etanercept, adalimumab and infliximab suggests that treatment with these drugs does not reduce the fertility of men and women. For ustekinumab (which is a newer drug) this has not been shown yet. However, because of the limited experience, women who plan to become
pregnant are advised to stop treatment with a biologic drug. For adalimumab, infliximab and ustekinumab it is advised that treatment should be stopped for at least six months before attempting to become pregnant (stopping contraceptive measures). For etanercept, treatment should be discontinued at least one month prior to conception. Please consult your dermatologist when you plan to become pregnant to discuss this further.

What happens when I am being treated with a biologic and discover that I am pregnant?

There are currently limited data available on the use of biologics during pregnancy. Based on the experience of women who became pregnant while taking biologic treatment, the use of these drugs appeared to be safe up to three months into pregnancy and was not associated with any adverse outcomes in the newborn. Therefore, whilst on biologic treatment there is no need to terminate the pregnancy but if possible this treatment should be stopped and detailed fetal ultrasound examination should be offered to confirm normal development.

After the first trimester, the biologic can be transferred from the mother to the baby and may cause changes in the development of the child’s immune system, the long term effects of this are unknown.

Can I (re)start treatment with a biologic when I am breastfeeding?

Biologics can be transferred to breast milk in very small amounts. However, there are to date no hints for biologic treatment in the breastfeeding mother to cause harm to the newborn. Therefore, if needed the biologic treatment may be started while the mother is still breastfeeding.

Where can I find more information about the use of biologics in pregnancy?
  • Schaefer, Peters, Miller: Drugs during pregnancy and lactation. 3rd edition (in preparation)
  • Bae YS, Van Voorhees AS, Hsu S, et al. Review of treatment options for psoriasis in pregnant or lactating women: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol
  • Griffiths CE. Management of psoriasis in pregnancy: time to deliver? Br J Dermatol 2010;163:235.
  • Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation. Part II. Lactation. J Am Acad Dermatol 2014;70:417.e1-417.e10
  • Murase JE, Heller MM, Butler DC. Safety of dermatologic medications in pregnancy and lactation: Part I. Pregnancy. J Am Acad Dermatol 2014;70:401.e1-401.e14.

While every effort has been made to ensure that the information given in this leaflet is accurate, not every treatment will be suitable or effective for every person. Your own doctor will be able to advice in greater detail.
This leaflet has been prepared by the EADV Task force “Skin disease in pregnancy”, it does not necessarily reflect the official opinion of the EADV.

March 2014