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.

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).

• Authors: Jonathan I Silverberg, Jacob P Thyssen, Eric L Simpson, Gil Yosipovitch, Sonja Ständer, Hernan Valdez, Ricardo Rojo, Pinaki Biswas, Daniela E Myers, Claire Feeney, Marco DiBonaventura
• Journal: American journal of clinical dermatology (Am J Clin Dermatol) Vol. 22 Issue 4 Pg. 541-554 (Jul 2021) ISSN: 1179-1888 [Electronic] New Zealand
• PMID: 33954933 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Chemical References

• Janus Kinase Inhibitors
• Pyrimidines
• Sulfonamides
• abrocitinib

Topics

• Administration, Oral
• Adolescent
• Adult
• Aged
• Anxiety (diagnosis, psychology)
• Depression (diagnosis, psychology)
• Dermatitis, Atopic (complications, diagnosis, drug therapy, psychology)
• Efficiency
• Fatigue (diagnosis, psychology)
• Female
• Humans
• Janus Kinase Inhibitors (administration & dosage, adverse effects)
• Male
• Middle Aged
• Patient Reported Outcome Measures
• Pruritus (complications, diagnosis, drug therapy, psychology)
• Pyrimidines (administration & dosage, adverse effects)
• Quality of Life
• Severity of Illness Index
• Sulfonamides (administration & dosage, adverse effects)
• Treatment Outcome
• Young Adult