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Impact of Oral Abrocitinib Monotherapy on Patient-Reported Symptoms and Quality of Life in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis of Patient-Reported Outcomes.
- Source :
-
American journal of clinical dermatology [Am J Clin Dermatol] 2021 Jul; Vol. 22 (4), pp. 541-554. Date of Electronic Publication: 2021 May 05. - Publication Year :
- 2021
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Abstract
- Background: Atopic dermatitis imparts a substantial patient burden, including itch, sleep disturbance, and decreased health-related quality of life.<br />Objective: This analysis evaluated changes in patient-reported outcomes of disease-specific signs/symptoms and health-related quality of life in adult and adolescent patients with moderate-to-severe atopic dermatitis treated with once-daily oral abrocitinib 200-mg or 100-mg monotherapy.<br />Methods: Pooled data from one phase IIb (NCT02780167) and two phase III (NCT03349060, JADE MONO-1; NCT03575871, JADE MONO-2) monotherapy trials in adult and adolescent patients with moderate-to-severe atopic dermatitis were analyzed. Patient-reported outcome assessments included: global severity, itch, and multi-item measures that assess other signs and symptoms of atopic dermatitis. Additional patient-reported outcome assessments measured depression, anxiety, fatigue, disease-specific and general health-related quality of life, and work and general productivity among employed patients.<br />Results: Overall, 942 patients were included in this analysis. Improvements were observed from the first post-baseline assessment to week 12 across all patient-reported outcomes, including Patient Global Assessment (PtGA) score of 0/1 (35.5%, 19.8%, and 5.9% for 200 mg, 100 mg, and placebo, respectively), ≥ 4-point improvement in Night Time Itch Scale (NTIS; 57.0%, 42.7%, and 12.7%), change from baseline in Patient-Oriented Eczema Measure (POEM) score (- 11.4, - 8.2, and - 3.4), 1-point improvement in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD; 75.2%, 65.1%, and 33.5%), Hospital Anxiety and Depression Scales (HADS) anxiety (- 2.0, - 1.7, and - 1.0) and depression (- 1.7, - 1.3, and - 0.1).<br />Conclusions: Abrocitinib monotherapy improved disease-specific signs/symptoms and health-related quality of life across multiple domains as reported by adult and adolescent patients with moderate-to-severe atopic dermatitis, complementing clinician-reported efficacy and safety outcomes.<br />Clinical Trial Registration: NCT02780167 (registered 23 May, 2016), NCT03349060 (registered 21 November, 2017), NCT03575871 (registered 3 July, 2018).
- Subjects :
- Administration, Oral
Adolescent
Adult
Aged
Anxiety diagnosis
Anxiety psychology
Depression diagnosis
Depression psychology
Dermatitis, Atopic complications
Dermatitis, Atopic diagnosis
Dermatitis, Atopic psychology
Efficiency
Fatigue diagnosis
Fatigue psychology
Female
Humans
Janus Kinase Inhibitors adverse effects
Male
Middle Aged
Patient Reported Outcome Measures
Pruritus complications
Pruritus diagnosis
Pruritus psychology
Pyrimidines adverse effects
Severity of Illness Index
Sulfonamides adverse effects
Treatment Outcome
Young Adult
Dermatitis, Atopic drug therapy
Janus Kinase Inhibitors administration & dosage
Pruritus drug therapy
Pyrimidines administration & dosage
Quality of Life
Sulfonamides administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1179-1888
- Volume :
- 22
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- American journal of clinical dermatology
- Publication Type :
- Academic Journal
- Accession number :
- 33954933
- Full Text :
- https://doi.org/10.1007/s40257-021-00604-9