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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.

A corresponding patient information leaflet on infliximab use in pregnancy is available at


Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced by recombinant DNA technology. It is administered in the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease and ulcerative colitis in patients where other systemic therapies are ineffective or unsuitable.

Data specific to infliximab use during pregnancy are very limited. Studies investigating use during the first trimester of pregnancy of anti-TNFα therapies as a group do not suggest an increased risk of congenital malformation in exposed offspring. There is currently no compelling evidence of an increased risk for spontaneous abortion, intrauterine death or adverse neurodevelopmental outcome; however the data are too limited to state that none exists. Low birth weight and preterm birth have been associated with in utero infliximab exposure in some studies but these findings are likely to reflect confounding by indication. 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 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 infliximab advises to delay administration of live vaccines to infants for six months 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. 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 or 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

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 or to ensure you are using the most up-to-date version.