Tralokinumab: A Comprehensive Monograph on a Targeted IL-13 Inhibitor for Atopic Dermatitis

Executive Summary

Tralokinumab is a first-in-class, fully human immunoglobulin G4 (IgG4​) monoclonal antibody that represents a significant advancement in the targeted treatment of atopic dermatitis (AD).[1] Marketed under the brand names Adbry® and Adtralza®, it is indicated for the treatment of moderate-to-severe AD in adult and adolescent patients (aged 12 years and older) who are candidates for systemic therapy.[3] The therapeutic action of tralokinumab is predicated on its high-affinity, specific binding to the interleukin-13 (IL-13) cytokine, a key driver of the Type 2 inflammation that underpins AD pathogenesis. By neutralizing IL-13, tralokinumab prevents its interaction with the IL-13Rα1/IL-4Rα receptor complex, thereby inhibiting the downstream signaling cascade responsible for skin barrier dysfunction, inflammation, and pruritus.[2]

The clinical efficacy and safety of tralokinumab were robustly established in the comprehensive ECZTRA Phase 3 clinical trial program. In pivotal monotherapy trials (ECZTRA 1 and 2), tralokinumab demonstrated statistically significant and clinically meaningful improvements in skin clearance, as measured by the Investigator's Global Assessment (IGA) score, and in disease severity, assessed by a 75% or greater improvement in the Eczema Area and Severity Index (EASI-75), compared to placebo at 16 weeks.[7] Efficacy was also demonstrated when used in combination with topical corticosteroids (ECZTRA 3) and in the adolescent population (ECZTRA 6), with long-term data from the ECZTEND extension study confirming durable responses and a consistent safety profile over several years of treatment.[5]