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

• Published in: American journal of clinical dermatology 2021-07, Vol.22 (4), p.541-554
• Main 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
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adolescent; Adult; Adults; Aged; Anxiety; Anxiety - diagnosis; Anxiety - psychology; Body image; Depression - diagnosis; Depression - psychology; Dermatitis; Dermatitis, Atopic - complications; Dermatitis, Atopic - diagnosis; Dermatitis, Atopic - drug therapy; Dermatitis, Atopic - psychology; Dermatology; Eczema; Efficiency; Fatigue; Fatigue - diagnosis; Fatigue - psychology; Female; Health behavior; Histamine; Humans; Janus Kinase Inhibitors - administration & dosage; Janus Kinase Inhibitors - adverse effects; Male; Medicine; Medicine & Public Health; Middle Aged; Original; Original Research Article; Patient Reported Outcome Measures; Patients; Pharmacology/Toxicology; Pharmacotherapy; Pruritus; Pruritus - complications; Pruritus - diagnosis; Pruritus - drug therapy; Pruritus - psychology; Pyrimidines - administration & dosage; Pyrimidines - adverse effects; Quality of Life; Questionnaires; Severity of Illness Index; Suicides & suicide attempts; Sulfonamides - administration & dosage; Sulfonamides - adverse effects; Teenagers; Treatment Outcome; Young Adult
• ISSN: 1175-0561; 1179-1888
• DOI: 10.1007/s40257-021-00604-9

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).