Adalimumab is a human monoclonal antibody which inhibits the biological activity of tumour necrosis factor alpha (TNFα). It is administered in the treatment of rheumatoid arthritis, enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriasis, Crohn’s disease and ulcerative colitis. Its use in these conditions is reserved for patients where other systemic therapies are ineffective or unsuitable.
Maternal autoimmune/inflammatory conditions are associated with increased risks of certain adverse pregnancy outcomes, including miscarriage, preterm delivery and low infant birth weight, particularly where the maternal condition is poorly controlled either around the time of conception and/or during pregnancy. Studies that have included disease-matched control groups suggest no additional increased risks relating to use of anti-TNFα therapies.
Studies that provide data on the safety of adalimumab use in pregnancy collectively describe more than 1,300 exposed pregnancies, with first trimester exposure confirmed in 491 of these. These data do not indicate that adalimumab use in pregnancy increases the overall risk of congenital malformation, or any specific malformation/pattern of malformations. The available evidence also does not suggest increased risks of miscarriage, intrauterine death, preterm delivery or impaired fetal growth following adalimumab use in pregnancy. A small number of uncontrolled case reports have described normal childhood development up to 3 years of age.
Use of immunosuppressant antibodies that actively cross the placenta during pregnancy could result in immunosuppression in the newborn and increase the risk of infection. Rare cases of fatal infection following BCG vaccination after in utero anti-TNFα exposure have been described in the literature. General guidance has been provided from a number of authorities around avoiding/deferring live vaccine use in infants exposed to adalimumab in utero. These recommendations vary depending on both the circumstances of adalimumab exposure and infant infection risk. UKTIS recommend a case-specific risk assessment approach when considering the use of live vaccines following in utero adalimumab exposure. Discussion with UKTIS is recommended in all cases where use of a live vaccine is being considered in an infant <12 months of age where there has been in utero exposure to adalimumab.
Pregnant women treated with adalimumab are likely to have additional fetal growth monitoring due to their underlying medical condition; no additional fetal monitoring is required as a result of adalimumab exposure specifically. 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 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 NHS health care professionals who are logged in.
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.