USE OF ETANERCEPT IN PREGNANCY

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(Date of issue: July 2015, Version: 2)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

Summary

Etanercept is a human tumour necrosis factor (TNF) receptor p75 Fc fusion protein monoclonal antibody produced by recombinant DNA technology. Etanercept is administered in the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and plaque psoriasis where other systemic therapies are ineffective or unsuitable.

Maternal autoimmune/inflammatory conditions are known to increase the risk of certain adverse pregnancy outcomes including spontaneous abortion, preterm delivery and low birth weight, and studies which include disease-matched control groups suggest no increased risk with use of anti-TNFα therapies.  

There are very limited data specific to etanercept use during pregnancy. Studies which investigate the use of anti-TNFα monoclonal antibodies during pregnancy have not found an overall increased risk of congenital malformation for these therapies as a class. There is also no compelling evidence of an increased risk for spontaneous abortion, intrauterine death or adverse neurodevelopmental outcome, however data are currently too limited to exclude adverse effects on the fetus. Low birth weight and preterm birth have been associated with in utero etanercept exposure in some studies but are likely to reflect at least some contribution of the underlying maternal condition. 

There is theoretical concern that the use of immunosuppressant antibodies that actively cross the placenta during pregnancy could result in immunosuppression in the newborn and increased risk of infection. The manufacturer of etanercept advises to delay administration of live vaccines to infants for 16 weeks after the mother's last dose on a precautionary basis.

Due to the lack of data, additional fetal monitoring may be warranted on a case-by-case basis. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.

This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to be sure you are using the most up-to-date version.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to health care professionals at www.toxbase.org.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.