Progressive and Sustained Disease Control in Patients with Atopic Dermatitis (AD) Aged 12–17 Years Treated with Tralokinumab for 52 Weeks

Abstract

Introduction: The ECZTRA 6 trial showed that tralokinumab 300mg provided progressive and sustained efficacy in adolescent patients with moderate-to-severe AD, and was well tolerated with a reassuring long-term safety profile over 52 weeks. Objective: To evaluate EASI response and PROs in adolescents from ECZTRA 6 treated with tralokinumab 300mg for the full 52-week treatment period. Methods: Patients were randomized to tralokinumab 300mg Q2W (n=97) or placebo (n=94) for 16 weeks. At Week 16, patients initiated on tralokinumab and achieving primary endpoints (IGA 0/1 and/or EASI-75) without rescue were re-randomized to tralokinumab 300mg Q2/4W monotherapy for 36 additional weeks; other patients were switched to open-label tralokinumab 300mg Q2W plus optional topical corticosteroids. Post-hoc analyses were conducted by pooling Week 16–52 data for all patients initially randomized to tralokinumab 300mg Q2W.  Results: Greater proportions of tralokinumab- vs placebo-treated patients achieved primary endpoints at Week 16; progressive improvement was seen through Week 52. In addition, pruritus NRS score was improved for a greater proportion of tralokinumab- vs placebo-treated patients from baseline to Week 16, with further improvement up to Week 52. Progressive improvements over time were also observed for proportions of patients with reductions of pruritus NRS ≥4, POEM ≥4, and CDLQI ≥6, from baseline.  The safety profile was consistent with prolonged treatment following Week 16.  Conclusions: At Week 16, tralokinumab 300mg Q2W improved EASI and PROs in adolescents with AD, with progressive and sustained improvement seen up to Week 52.