Patient-Reported Symptoms and Disease Impacts in Adults With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 2b Study With Abrocitinib.

Abstract

BACKGROUND:

Moderate-to-severe atopic dermatitis (AD) is inadequately controlled with current treatments for many patients. Abrocitinib is an oral Janus kinase 1 selective inhibitor under investigation for the treatment of AD.

OBJECTIVE:

The aim of the study was to evaluate patient-reported outcomes in a phase 2b study of abrocitinib in adults with moderate-to-severe AD inadequately controlled by topical therapy (NCT02780167).

METHODS:

Patients (N = 267) were randomly assigned 1:1:1:1:1 to 12-week, once-daily abrocitinib (200, 100, 30, 10 mg) or placebo. Patient-reported outcomes included pruritus numeric rating scale (average), Patient Global Assessment, Patient-Oriented Eczema Measure, Pruritus and Symptoms Assessment for AD, Dermatology Life Quality Index, and Hospital Anxiety and Depression Scale (HADS).

RESULTS:

Abrocitinib 200 or 100 mg resulted in significantly greater improvements from baseline versus placebo in peak pruritus numeric rating scale (by days 2 and 3, respectively), Patient-Oriented Eczema Measure, Pruritus and Symptoms Assessment for AD, Dermatology Life Quality Index, and HADS (200 mg only, by week 1 or 2), and proportions of the patients with Patient Global Assessment clear/almost clear with 2-point or greater improvement (by weeks 1 and 4, respectively) that continued through week 12 (except HADS).

CONCLUSIONS:

Abrocitinib treatment resulted in rapid (2 days to 2 weeks) and persistent improvements in AD symptoms and impacts in moderate-to-severe disease.

• Authors: Eric L Simpson, Andreas Wollenberg, Robert Bissonnette, Jonathan I Silverberg, Jocelyne Papacharalambous, Linda Zhu, Weidong Zhang, Jean S Beebe, Michael Vincent, Elena Peeva, Andrew G Bushmakin, Joseph C Cappelleri, Linda Chen, Vanja Sikirica, Jason Xenakis
• Journal: Dermatitis : contact, atopic, occupational, drug (Dermatitis) Vol. 32 Issue 1S Pg. S53-S61 (Oct 01 2021) ISSN: 2162-5220 [Electronic] United States
• PMID: 33795561 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2021 American Contact Dermatitis Society. All Rights Reserved.

Chemical References

• Pyrimidines
• Sulfonamides
• abrocitinib

Topics

• Adult
• Dermatitis, Atopic (complications, drug therapy, psychology)
• Double-Blind Method
• Eczema (drug therapy)
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Patient Reported Outcome Measures
• Patient Satisfaction (statistics & numerical data)
• Pruritus (etiology)
• Pyrimidines (therapeutic use)
• Severity of Illness Index
• Sulfonamides (therapeutic use)
• Treatment Outcome
• Young Adult