1. 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.
- Author
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Silverberg JI, Thyssen JP, Simpson EL, Yosipovitch G, Ständer S, Valdez H, Rojo R, Biswas P, Myers DE, Feeney C, and DiBonaventura M
- 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
- Abstract
Background: Atopic dermatitis imparts a substantial patient burden, including itch, sleep disturbance, and decreased health-related quality of life., 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., 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., 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)., 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., Clinical Trial Registration: NCT02780167 (registered 23 May, 2016), NCT03349060 (registered 21 November, 2017), NCT03575871 (registered 3 July, 2018).
- Published
- 2021
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