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).

Conflict of interest statement

Jonathan I. Silverberg has served as an investigator for Celgene, Eli Lilly, F. Hoffmann-LaRoche, Menlo Therapeutics, Realm Therapeutics, Regeneron, and Sanofi; as a consultant for Pfizer Inc., AbbVie, Anacor, AnaptysBio, Arena Pharmaceuticals, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Glenmark, Incyte, Kiniksa, LEO Pharma, Menlo Therapeutics, Novartis, Realm Therapeutics, Regeneron, and Sanofi; and as a speaker for Regeneron and Sanofi. Jacob P. Thyssen is an advisor/investigator or speaker for Pfizer, AbbVie, Eli Lilly, LEO Pharma, Regeneron, and Sanofi-Genzyme. Eric L. Simpson is a consultant for Pfizer, AbbVie, Celgene, Eli Lilly, Galderma, GlaxoSmithKline, Menlo Therapeutics, LEO Pharma, and Regeneron and a principal investigator for AbbVie, GlaxoSmithKline, LEO Pharma, Novartis, Regeneron, Tioga Pharmaceuticals, and Vanda Pharmaceuticals. Gil Yosipovitch has been a consultant and advisor for Bellus, Pfizer, Eli Lilly, Galderma, LEO Pharma, Kiniksa Pharmaceuticals, Menlo Therapeutics, Novartis, Sanofi-Regeneron, and Trevi Therapeutics, and a principal investigator for Pfizer, Galderma, Kiniksa Pharmaceuticals, LEO Pharma, Sanofi-Regeneron, Novartis, and Sun Pharmaceutical Industries. Sonja Ständer is a consultant and/member of advisory boards for Pfizer Inc., Almirall, Bayer, Beiersdorf, Bellus Health, Bionorica, Cara Therapeutics, Celgene, Clexio, DS Biopharma, Galderma, Menlo Therapeutics, Novartis, Nuformix, Perrigo, Sanofi, Sienna Biopharmaceutical, Trevi Therapeutics, and Vifor Pharma; has received research grants from the German Research Foundation (DFG), the European Academy of Dermatology and Venereology (EADV), Almirall, Beiersdorf, Galderma, LEO Pharma, Kiniksa Pharmaceuticals, Menlo Therapeutics, Novartis, Sanofi, and Trevi Therapeutics; and has been an investigator for Dermasence, Galderma, Kiniksa Pharmaceuticals, Menlo Therapeutics, Novartis, Sanofi, Trevi Therapeutics, and Vanda Pharmaceuticals. Hernan Valdez, Ricardo Rojo, Pinaki Biswas, Daniela E. Myers, Claire Feeney, and Marco DiBonaventura are employees and shareholders of Pfizer Inc.

Figures

Fig. 1

Proportion of patients with a a ≥ 4-point improvement in the Night Time Itch Scale (NTIS) score, b a 1-point improvementa in the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) total score, c Patient Global Assessment (PtGA) of clear or almost clear with a ≥ 2-point improvement, and d a change from baseline in the Patient-Oriented Eczema Measure (POEM) total score. CI confidence interval, LSM least-squares mean. a≥ 1-point improvement is the clinically important response for the PSAAD total score

Fig. 2

Change in Hospital Anxiety and Depression Scale (HADS) a depression and b anxiety subscale scores. CI confidence interval, LSM least-squares mean

Fig. 3

Change from baseline in a the EuroQol 5-Dimension 5-Level Scale (EQ 5D-5L) index score, ab EuroQol 5-Dimension Youth Scale (EQ 5D-Y) index scores,b and c Short Form-36 Health Survey, Version 2, Acute (SF-36v2) scores at week 12. CI confidence interval, LSM least-squares mean. aFor patients ≥ 18 years of age. bFor patients < 18 years of age

Fig. 4

Impact of treatment on a Dermatology Life Quality Index (DLQI)a and b Children’s Dermatology Life Quality Index (CDLQI)b band descriptors. aFor patients ≥ 8 years of age. bFor patients < 18 years of age