Key clinical point: Tralokinumab-mediated specific targeting of interleukin-13 is effective and safe in treating adolescents with moderate-to-severe atopic dermatitis (AD).
Major finding: At week 16, a significantly higher proportion of patients receiving 150 mg or 300 mg tralokinumab vs placebo achieved an Investigator’s Global Assessment score of 0 or 1 (21.4% and 17.5% vs 4.3%; P < .001 and P = .002, respectively) and ≥75% improvement in the Eczema Area and Severity Index score (28.6% and 27.8% vs 6.4%, respectively; both P < .001) without rescue medication. Most adverse events were mild or moderate in severity.
Study details: Findings are from the phase 3 ECZTRA 6 trial including 289 adolescents (12-17 years) with moderate-to-severe AD who were randomly assigned to receive 150 mg tralokinumab (n = 98), 300 mg tralokinumab (n = 97), or placebo (n = 94).
Disclosures: This study was funded by LEO Pharma. Some authors reported ties with various organizations including LEO Pharma. Five authors declared being employees of or holding shares in LEO Pharma.
Source: Paller AS et al. Efficacy and safety of tralokinumab in adolescents with moderate to severe atopic dermatitis: The phase 3 ECZTRA 6 randomized clinical trial. JAMA Dermatol . 2023 (Apr 19). Doi: 10.1001/jamadermatol.2023.0627