Injectable tralokinumab gives new hope to patients with severe atopic dermatitis

Atopic dermatitis (AD) is a chronic, inflammatory skin disease that affects up to 20% of children and 3% of adults globally. In patients with severe disease, their AD may not be controlled with topical therapy (applied to the skin), and they may require drugs administered either orally or by injection. Many of these treatments, such as ciclosporin A (CSA), suppress the immune system and have potentially serious side effects. Tralokinumab is an injectable monoclonal antibody that targets interleukin‐13, a key driver of AD. This European, multicentre study (ECZTRA 7 – sponsored by LEO Pharma) reports the results of a randomized, double‐blind, placebo‐controlled study of tralokinumab plus topical steroids for adult patients with severe AD who had not responded adequately to CSA or there were reasons why CSA was not a suitable treatment for them. Unfortunately, the study was conducted partly during the COVID‐19 pandemic, which impacted the research and data collection. Two hundred seventy-seven patients were randomized to receive active tralokinumab (300 mg) or sham tralokinumab subcutaneous injections combined with topical steroids every two weeks. After 16 weeks, patients receiving the active treatment had a statistically significant better response than the control group who received the sham treatment. Approximately two‐thirds of the active treatment group had achieved the study improvement endpoint compared with only half of the control group. This difference was more marked by week 26 of the study. The incidence of side effects was similar in both groups.