![]() Mono symptoms in adults trial#A phase IIb trial in adults with moderate-to-severe AD showed that abrocitinib was safe and effective in reducing signs and symptoms of AD based on Investigator’s Global Assessment (IGA) response (clear or almost clear with ≥ 2-grade improvement) and change in Eczema Area and Severity Index (EASI) score from baseline. Monotherapy with once-daily oral abrocitinib showed significant efficacy in three phase II/III placebo-controlled trials in adolescents and adults with moderate-to-severe AD. By selectively inhibiting JAK1, abrocitinib modulates the signaling pathways of several key cytokines involved in the pathogenesis of AD and pruritus. Ībrocitinib is an oral, once-daily, Janus kinase 1 (JAK1) selective inhibitor under investigation for the treatment of moderate-to-severe AD. Atopic dermatitis is also associated with a higher work absentee rate, causing substantial direct and indirect costs. Pruritus is the most common and bothersome symptom of AD and is associated with sleep disturbance, which additionally may lead to psychological comorbidities, including anxiety, depression, and fatigue. Moderate-to-severe AD negatively affects patient health-related quality of life (HRQoL), impacting patients, their finances, families, and society in general. Mono symptoms in adults skin#These results provide important information on the efficacy of abrocitinib from the patient perspective and complement clinician-reported efficacy and safety outcomes from previous phase IIb and III monotherapy trials.Ītopic dermatitis (AD) is a chronic, relapsing, inflammatory skin condition with a high disease and comorbidity burden that affects up to 20% of children and 5–10% of adults worldwide. Improvements in itch, sleep disturbance, skin pain, and health-related quality of life were evident as early as week 2 and sustained over a period of 12 weeks. The pooled analysis from three monotherapy studies (N = 942) showed that adults and adolescents with moderate-to-severe atopic dermatitis treated with abrocitinib experienced clinically meaningful improvements in all patient-reported outcomes, especially itch, depression/anxiety, fatigue, and work productivity, which represent some of the most burdensome impacts of atopic dermatitis. NCT02780167 (registered 23 May, 2016), NCT03349060 (registered 21 November, 2017), NCT03575871 (registered 3 July, 2018).Ībrocitinib, an oral, once-daily, Janus kinase 1 selective inhibitor, showed efficacy and a manageable safety profile for adult and adolescent patients with moderate-to-severe atopic dermatitis in phase IIb and III trials this analysis focuses on patient-report outcome assessments in phase IIb and phase III monotherapy trials. ConclusionsĪbrocitinib 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. 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). Overall, 942 patients were included in this analysis. 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. Patient-reported outcome assessments included: global severity, itch, and multi-item measures that assess other signs and symptoms of atopic dermatitis. 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. 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. Atopic dermatitis imparts a substantial patient burden, including itch, sleep disturbance, and decreased health-related quality of life. ![]()
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