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 and SOLO 2, AD ADOL, and CHRONOS.

Abstract

BACKGROUND:

Pruritus (itch) is a cardinal symptom in atopic dermatitis (AD).

OBJECTIVE:

To evaluate the timing and effect of dupilumab on itch.

METHODS:

Analysis of data from 1505 patients with moderate to severe AD included in 4 randomized controlled studies, treated for up to 52 weeks. Adults received dupilumab 300 mg every 2 weeks or placebo monotherapy (SOLO 1: NCT02277743; SOLO 2: NCT02277769), with concomitant topical corticosteroids (CHRONOS: NCT02260986); adolescents (≥12 to <18 y) were treated with dupilumab monotherapy every 2 weeks (200 mg for baseline weight of <60 kg; 300 mg for baseline weight of ≥60 kg) or placebo (AD ADOL: NCT03054428).

RESULTS:

Dupilumab showed significant rapid improvements from baseline in daily Peak Pruritus Numerical Rating Scale scores versus 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 Peak Pruritus Numerical Rating Scale scores: SOLO -47.5% vs -20.5%; AD-ADOL -47.9% vs -19.0%; CHRONOS -57.3% vs -30.9% (P < .0001 for all).

LIMITATIONS:

Short duration of monotherapy trials (16 weeks).

CONCLUSION:

Across 4 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.

• Authors: Jonathan I Silverberg, Gil Yosipovitch, Eric L Simpson, Brian S Kim, Jashin J Wu, Laurent Eckert, Isabelle Guillemin, Zhen Chen, Marius Ardeleanu, Ashish Bansal, Mandeep Kaur, Ana B Rossi, Neil M H Graham, Naimish Patel, Abhijit Gadkari
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 82 Issue 6 Pg. 1328-1336 (Jun 2020) ISSN: 1097-6787 [Electronic] United States
• PMID: 32135208 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antibodies, Monoclonal, Humanized
• Dermatologic Agents
• dupilumab

Topics

• Adolescent
• Adult
• Antibodies, Monoclonal, Humanized (administration & dosage, therapeutic use)
• Dermatitis, Atopic (complications, drug therapy)
• Dermatologic Agents (administration & dosage, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Humans
• Pruritus (drug therapy, etiology)
• Severity of Illness Index
• Young Adult