Tralokinumab Receives FDA Approval for Atopic Dermatitis in Adults

Novel biologic tralokinumab received FDA approval for the treatment of moderate to severe atopic dermatitis (AD) in adults. It is the first biologic that specifically targets IL-13, a cytokine known to play a role in the skin biology and inflammation seen in AD.

Approval came after tralokinumab demonstrated safety and efficacy in three pivotal phase 3 trials (ECZTRA 1, ECZTRA 2, ECZTRA 3) with approximately 2000 patients with moderate to severe AD. Across the trials, patients who received tralokinumab 300 mg alone or with topical corticosteroids as needed achieved Investigator Global Assessment scores of clear or almost clear or 75% improvement in Eczema Area and Severity Index score by week 16. Additionally, these patients achieved at least a 4-point reduction in weekly average Worst Daily Pruritus Numeric Rating Scale (NRS) on the 11-point NRS.

Frequency of adverse events (AEs) was similar to placebo in the trials, with upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia as the most common AEs.

Dosing of tralokinumab will be an initial 600-mg loading dose injected subcutaneously followed by 300 mg every other week. Dermatologists may consider reducing administration frequency to 300 mg every 4 weeks for patients weighing below 100 kg and who achieve clear or almost clear skin after 16 weeks of treatment. Patients may use tralokinumab with or without topical corticosteroids.

Reference
LEO Pharma announces FDA approval of Adbry^™ (tralokinumab-ldrm) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis. Press release. LEO Pharma; December 28, 2021. Accessed December 28, 2021. https://www.businesswire.com/news/home/20211227005159/en/LEO-Pharma-announces-FDA-approval-of-Adbry%E2%84%A2-tralokinumab-ldrm-as-the-first-and-only-treatment-specifically-targeting-IL-13-for-adults-with-moderate-to-severe-atopic-dermatitis