Tralokinumab Effective Across Racial Groups in Atopic Dermatitis: Phase III Analysis
USA: A post-hoc analysis of phase III clinical trials suggests that tralokinumab demonstrates consistent efficacy and a favorable safety profile in patients with moderate-to-severe atopic dermatitis (AD) across Asian, Black, and White racial subgroups. The findings indicate meaningful improvement in disease severity, symptoms, and biological markers, with benefits sustained over long-term treatment.
The study, published in the American Journal of Clinical Dermatology, was conducted by Tiffany Mayo and colleagues from the University of Alabama at Birmingham. Researchers assessed whether responses to tralokinumab, an interleukin-13–targeting monoclonal antibody, varied across racial subgroups in patients with moderate-to-severe AD.
Atopic dermatitis is a chronic inflammatory skin disorder characterized by intense itching, eczematous lesions, and impaired quality of life. Previous research has highlighted potential differences in disease expression and underlying biology across racial and ethnic groups, but clinical trial data in diverse populations have remained limited.
The analysis pooled data from more than 3,200 participants enrolled in four phase III studies, including the placebo-controlled ECZTRA 1, 2, and 3 trials and the long-term ECZTEND extension study. Patients self-identified as Asian, Black, or White and received tralokinumab or placebo, with outcomes assessed over 16 weeks and extended follow-up periods.
The analysis revealed the following findings:
- Baseline characteristics were generally similar across treatment groups and racial subgroups, though Black patients more often had moderate disease severity, with some regional variation in biomarker profiles.
- Among Asian patients, especially those from Japan, higher baseline inflammatory biomarker levels were observed, while Asian patients from Western regions showed lower Staphylococcus aureus colonization after adjustment for disease severity.
- At 16 weeks, tralokinumab showed superior efficacy versus placebo across all racial subgroups, improving IGA scores and EASI-75 outcomes, indicating better skin clearance and reduced disease activity.
- Long-term data showed sustained benefit, with EASI-75 responses at week 56 seen in 78% of Asian, 88% of Black, and 83% of White patients, reflecting durable efficacy.
- Treatment was associated with reductions in inflammatory biomarkers linked to atopic dermatitis, consistent with clinical improvements across all groups.
- Tralokinumab was generally well tolerated, with adverse event rates similar across racial subgroups and comparable to placebo, and serious adverse events or discontinuations occurring infrequently.
The authors concluded that tralokinumab provides consistent clinical benefit and an acceptable safety profile in diverse patient populations with moderate-to-severe atopic dermatitis. They emphasized that long-term improvements across racial subgroups highlight its potential as a broadly effective targeted therapy, while also underscoring the importance of further research into racial differences in disease biology and treatment response.
Reference:
Mayo T, Silverberg JI, Armstrong A, Guttman-Yassky E, Blauvelt A, Esdaile B, Kabashima K, Gooderham M, Kircik L, Schneider S, Bennike N, von Eyben R, Martel BC, Røpke MA, Katoh N, Alexis AF. Efficacy and Safety of Tralokinumab Across Racial Subgroups in Adults with Moderate-to-Severe Atopic Dermatitis: Post Hoc Analysis of Phase III Trials. Am J Clin Dermatol. 2026 Jan;27(1):149-166. doi: 10.1007/s40257-025-00985-1. Epub 2025 Oct 21. PMID: 41118053; PMCID: PMC12860764.
Next Story