Post-authorisation safety study of tralokinumab use in pregnancy


Tralokinumab is a biological agent developed for the treatment of moderate to severe atopic dermatitis (AD) and is administered by subcutaneous injection. Tralokinumab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that specifically neutralizes the interleukin (IL)-13 cytokine by inhibiting the interaction with IL-13 receptors. IL-13 is thought to play a role in blastocyst implantation and is found in the placenta. IgG4 antibodies like tralokinumab have been found to cross the placental barrier. Therefore, tralokinumab could in theory interfere with reproductive function through this mechanism and perhaps others. However, non-clinical studies with tralokinumab in monkeys demonstrated no reproductive or developmental toxicity of tralokinumab. As a precautionary measure, the summary of product characteristics (SmPC) advises women to avoid using tralokinumab during pregnancy.

There is little evidence that AD in itself increases the risk of adverse pregnancy outcomes. However, secondary skin infection causing eczema herpeticum may be associated with preterm delivery, intrauterine growth restriction, and miscarriage. Acknowledging that AD is a common disease in women of childbearing age, exposure to tralokinumab during pregnancy is likely to occur despite the recommendation not to use tralokinumab during pregnancy. This study will investigate whether maternal exposure to tralokinumab during pregnancy is associated with an increased risk of adverse pregnancy and infant outcomes. Tralokinumab was approved by the European Medicines Agency (EMA) on 17-Jun-2021 for the treatment of moderate to severe AD in adult patients who are candidates for systemic therapy. EMA has requested the conduct of this study as part of the market authorization of tralokinumab. The final study report is planned for Q4 2030.

Funding period

Begin:   January 2023
End:   December 2030


  • LEO Pharma


 Jonas Reinold

Project management (international)

Elena Rivero, RTI Health Solutions, Barcelona, Spain