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- Title
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.
- Authors
Silverberg, Jonathan I.; Thyssen, Jacob P.; Simpson, Eric L.; Yosipovitch, Gil; Ständer, Sonja; Valdez, Hernan; Rojo, Ricardo; Biswas, Pinaki; Myers, Daniela E.; Feeney, Claire; DiBonaventura, Marco
- 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).
- Subjects
META-analysis; ORAL drug administration; HEALTH outcome assessment; HEALTH status indicators; SEVERITY of illness index; JANUS kinases; TREATMENT effectiveness; PATIENTS' attitudes; ATOPIC dermatitis; QUALITY of life; MENTAL depression; ITCHING; DESCRIPTIVE statistics; NEUROTRANSMITTER uptake inhibitors; ANXIETY; FATIGUE (Physiology); EVALUATION; SYMPTOMS; ADULTS; ADOLESCENCE
- Publication
American Journal of Clinical Dermatology, 2021, Vol 22, Issue 4, p541
- ISSN
1175-0561
- Publication type
Article
- DOI
10.1007/s40257-021-00604-9