USE OF USTEKINUMAB IN PREGNANCY

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(Date of issue: May 2015, Version: 1)

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

Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced using recombinant DNA technology. Ustekinumab is administered in the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in patients where other systemic therapies are ineffective or unsuitable.

Maternal autoimmune/inflammatory conditions are known to be associated with increased risk of certain adverse pregnancy outcomes such as spontaneous abortion, preterm delivery and low birth weight. Adequate control of the maternal condition may therefore decrease the risk of such adverse pregnancy outcomes, however robust data to support this are not yet available.

Data on the use of ustekinumab are extremely limited and currently consists of only five published case reports and unpublished data from the manufacturer. An evidence-based evaluation of risk to the fetus with maternal use during pregnancy is thus not possible. Although there is no signal to suggest increased risk of congenital malformation, and transplacental transport of ustekinumab is not expected until after the first trimester, the data are too limited to exclude a risk due indirect fetal effects (e.g. as a consequence of altered placental or maternal physiology). In most reported cases ustekinumab has been discontinued on recognition of the pregnancy, and there are thus very little data relating to embryonic/fetal exposure to the drug beyond the first trimester.  

There is a theoretical concern that the use of immunosuppressant antibodies that actively cross the placenta during pregnancy could result in immunosuppression and increased risk of infection in the neonate. Data is lacking for ustekinumab, however until data becomes available it may be prudent to delay the use of live vaccines in the neonate on a precautionary basis.

Due to the current 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. Please report all cases of ustekinumab exposure to UKTIS.

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.