Tralokinumab maintains efficacy in adults with moderate-to-severe atopic dermatitis up to 152 weeks

BACKGROUND: Atopic dermatitis (AD) is a relapsing and remitting skin disease often requiring long-term treatment. Tralokinumab, a monoclonal antibody specifically neutralizing interleukin-13, is approved for moderate-to-severe AD treatment in multiple countries. OBJECTIVES: Assess long-term efficacy of tralokinumab in adults with moderate-to-severe AD treated for up to 4 years. METHODS: This post hoc interim analysis included the subgroup of patients (n = 347) who completed 52 weeks of tralokinumab in the Phase 3 ECZTRA 1 or ECZTRA 2 (NCT03131648/NCT03160885) trials and subsequently enrolled in the open-label extension trial ECZTEND (NCT03587805; receiving tralokinumab plus optional topical corticosteroids/calcineurin inhibitors [TCS/TCI]) ≥152 weeks prior to data cut-off (30-April-2022). RESULTS: At ECZTEND Week 152, 52.6% (95% CI 45.2; 59.8) of patients achieved Investigator's Global Assessment 0/1 (clear or almost clear skin) and 84.5% (95% CI 78.4; 89.1) achieved ≥75% improvement in Eczema Area and Severity Index (EASI) from parent trial baseline; additionally, 84.5% (95% CI 78.4; 89.1), 68.0% (95% CI 60.8; 74.5) and 79.0% (95% CI 72.1; 84.6) reached EASI ≤7 (no-to-mild disease), Worst Weekly Pruritus Numeric Rating Scale ≤4 (no-to-mild itch) and Dermatology Life Quality Index ≤5 (no-to-small effect on quality of life), respectively. Responses were stable over time, with 71.4% (95% CI 66.3; 76.0) of patients maintaining EASI ≤7 at ≥80% of days between Week 16 and 152 in ECZTEND. During ECZTEND, 28.5% of patients discontinued: 7.5% due to lack of efficacy and 5.8% due to adverse events (AEs). The most frequently reported AEs in ECZTEND were consistent with the known safety profile of tralokinumab, including nasopharyngitis (IR = 13.6), upper respiratory tract infection (IR = 4.4) and conjunctivitis (IR = 2.3). CONCLUSIONS: These data suggest that tralokinumab plus optional TCS/TCI provides long-term stable disease control, equivalent to no-to-mild disease, in a subgroup of adults with moderate-to-severe AD who completed 1 year of treatment in parent trials and up to 3 years in ECZTEND.