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). Supplementary Information The online version contains supplementary material available at 10.1007/s40257-021-00604-9.

Abrocitinib: First Approval

“…The efficacy of abrocitinib monotherapy in the treatment of moderate-to-severe AD in adults and adolescents is supported by a pooled analysis ( n = 942) of the phase 3 JADE MONO-1 and MONO-2 trials and the phase 2b study (NCT02780167) [ 25 , 26 ]. For instance, the proportion of patients who achieved a PP-NRS4 response was numerically greater with abrocitinib 100 mg/day ( n = 369) and 200 mg/day ( n = 363) than with placebo ( n = 210) at all timepoints evaluated from week 2 (24.9% and 44.2% vs 5.8%) to week 12 (42.9% and 57.3% vs 16.5%) [ 25 ].…”

Once-Daily Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis in Adults and Adolescents Aged 12 Years and Over: A Short Review of Current Clinical Perspectives

“…An IGA score of 0 or 1 (meaning, clear to almost clear) with an improvement of ≥2 grades from baseline and a PP-RNS improvement of at least 4 points from baseline were necessary in order for the drug to be considered as clinical effective, and the results found concerning these items reflected those of the EASI score, meaning that abrocitinib in 200 mg doses registered the best results, with decreasing efficacy for abrocitinib 100 mg per dose and, respectively, dupilumab. 8 , 13 , 27 , 30 , 34 , 35 These changes were also registered in a phase IIb trial, which included adult patients suffering from moderate-to-severe forms of AD, and also reporting better results for the 200 mg per dose oral abrocitinib, for all patient-reported outcomes. 30 , 33 , 35 …”

“…PSAAD reports the patient’s symptoms in the last 24 hours, while NTIS reports the worst itching during the most recent sleep during the night and while SCORAD reports sleep loss during the last 3 nights prior to the evaluation. 26 , 27 , 30 …”

“…The CDLQI reflects a better response to treatment when patients report higher scores, thus a higher impact in moderate-to-severe AD; all three studies revealed that abrocitinib had a “very large effect” on these patients, with the 200 mg dosage yielding better results. 26 , 27 …”

“… 9 , 24 Also, studies which evaluated the patients’ quality of life reported major progress, with improved work and an improved productivity (for patients in the work field), changes which were statistically significant for abrocitinib as compared to the placebo groups, even with or without topical corticosteroids. 24 , 27 The Committee for Medicinal Products for Human Use of the European Medicines Agency supports the marketing authorization for abrocitinib in treating AD, a statement issued in October. Recently, in December 2021, abrocitinib was approved in Europe for the treatment of moderate-to-severe AD in the adult population (candidates for systemic treatment) in dosages of 100 mg and 200 mg per day; also, a dosage of 50 mg a day was approved for those suffering from moderate-to-severe renal impairment and for patients treated with P450 cytochrome inhibitors.…”