MEANINGFUL RESPONSES IN TRALOKINUMAB-TREATED ADOLESCENTS WITH ATOPIC DERMATITIS NOT ACHIEVING IGA 0/1 AT WEEK-16

Abstract

<h3>Introduction</h3> In the monotherapy phase 3 trial (ECZTRA 6, NCT03526861) in adolescents with moderate-to-severe atopic dermatitis (AD) treated with tralokinumab, IGA of clear/almost clear skin (IGA 0/1) at Week 16 was a primary endpoint. IGA 0/1 can be a high standard to achieve for patients with moderate-to-severe AD and may not fully reflect achievement of other clinically meaningful parameters, such as improvement in signs, symptoms, and/or quality-of-life (QoL). <h3>Methods</h3> Adolescents (12-17 years) were randomized to subcutaneous tralokinumab 150mg or 300mg, or placebo, every 2 weeks. Patients who did not achieve IGA 0/1 at Week 16 and/or utilized rescue therapy were included in this <i>post-hoc</i> analysis. Non-responder imputation was used for patients who utilized rescue therapy or had missing data. Clinically meaningful responses were defined as EASI-50, ≥3-point improvement in pruritus NRS, or ≥6-point improvement in CDLQI. <h3>Results</h3> At Week 16, 78.6% and 82.5% of tralokinumab-treated patients (150mg/300mg) versus 95.7% (placebo) exhibited IGA>1 and/or used rescue therapy. 36.4% (150mg) and 52.5% (300mg) of patients with IGA>1 in the tralokinumab arms, compared to 21.1% (placebo), achieved clinically meaningful responses in at least one measure: EASI-50, pruritus NRS, or CDLQI. Greater proportions of tralokinumab-treated patients (150mg/300mg vs. placebo) achieved EASI-50 (31.2%/41.3% vs. 10.0%) and ≥3-point improvement in pruritus NRS (21.6%/22.8% vs. 8.0%). A greater proportion of tralokinumab 300mg patients vs. placebo (35.2% vs. 15.0%) achieved ≥6-point improvement in CDLQI. <h3>Conclusion</h3> Many tralokinumab-treated adolescents who did not achieve IGA 0/1 at Week 16 and/or used rescue therapy still achieved clinically meaningful improvements in AD signs, symptoms, and/or QoL.