Dupilumab treatment results in early and sustained improvements in itch in adolescents and adults with moderate-to-severe atopic dermatitis: analysis of the randomized phase 3 studies SOLO 1 & SOLO 2, AD ADOL, and CHRONOS.

Abstract Background Pruritus (itch) is a cardinal symptom in atopic dermatitis (AD). Objective Evaluate the timing and effect of dupilumab on itch. Methods Analysis of data from 1,505 patients with moderate-to-severe AD included in four randomized controlled studies, treated for up to 52 weeks. Adults received dupilumab 300 mg every 2 weeks (q2w) or placebo monotherapy (SOLO1-2; NCT02277743, NCT02277769), with concomitant topical corticosteroids (CHRONOS, NCT02260986); adolescents (≥12– Results Dupilumab showed significant rapid improvements from baseline in daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores vs placebo, by day 2 in adults and day 5 in adolescents. At treatment end, dupilumab vs placebo/control had greater least-squares mean percent change from baseline in the weekly average of PP-NRS scores: SOLO −47.5% vs −20.5%; AD-ADOL −47.9% vs −19.0%; CHRONOS −57.3% vs −30.9% (P Limitations Short duration of monotherapy trials (16 weeks). Conclusion Across four randomized trials, dupilumab treatment showed rapid and sustained improvements in the magnitude of itch, starting with first dose; responses progressively increased and were sustained through to the end of treatment, up to 1 year.