Tralokinumab-ldrm Approved for Treatment of Moderate to Severe Atopic Dermatitis in Pediatric Patients

The US Food and Drug Administration recently announced approval of tralokinumab-ldrm (Adbry) to include pediatric patients aged 12 to 17 years with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.^1,2

Tralokinumab-ldrm injection is indicated for people ages 12 years and older with moderate to severe AD that is not well controlled with prescription topical therapies, or who cannot use topical therapies. It can be used with or without topical corticosteroids.

This approval follows data from the Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of tralokinumab-ldrm in 289 pediatric patients aged 12 to 17 years with moderate to severe AD who were candidates for systemic therapy. A total of 98 patients received an initial dose of tralokinumab-ldrm 300 mg followed by 150 mg every other week up to week 16. The trial met its primary and key secondary endpoints.² The data showed that more than 5 times as many pediatric patients had clear or almost clear skin with tralokinumab-ldrm compared to placebo, with 21% of patients who received tralokinumab-ldrm achieving an Investigator's Global Assessment score of 0 (“clear”) or 1 (“almost clear”) compared to 4% who received placebo. About 5 times as many pediatric patients saw a substantial disease improvement with tralokinumab-ldrm compared to placebo. Additionally, more than 7 times as many pediatric patients experienced significantly reduced itch with tralokinumab-ldrm compared to placebo. Finally, in the ECZTRA 6 trial, a higher proportion of pediatric patients who received tralokinumab-ldrm achieved at least a 90% improvement in their Eczema Area and Severity Index score, or EASI-90, compared to placebo.

The safety profile was assessed through the initial treatment period of 16 weeks and the long-term period of 52 weeks, and it was comparable to the safety profile from trials in adults with AD. In the ECZTRA 1, 2, and 3 adult trials, the most common adverse events (incidence ≥1%) were upper respiratory tract infections (mainly reported as the common cold), conjunctivitis, injection site reactions, and eosinophilia.

References
1. LEO Pharma Inc. announces U.S. FDA approval of Adbry (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in pediatric patients aged 12-17 years. Press release. Business Wire. December 15, 2023. Accessed December 18, 2023. https://www.businesswire.com/news/home/20231215374551/en/LEO-Pharma-Inc.-Announces-U.S.-FDA-approval-of-Adbry%C2%AE-tralokinumab-ldrm-for-the-Treatment-of-Moderate-to-severe-Atopic-Dermatitis-in-Pediatric-Patients-Aged-12-17-Years

2. Adbry(tralokinumab-ldrm) prescribing information. LEO Pharma. December 2023.