Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate‐to‐severe atopic dermatitis: an analysis of patient‐reported outcomes.

Background: A significant improvement in clinical signs was demonstrated with abrocitinib relative to placebo in adolescents with moderate‐to‐severe atopic dermatitis (AD) in three phase 3, randomized, double‐blinded, placebo‐controlled studies (JADE TEEN [ClinicalTrials.gov, NCT03796676], JADE MONO‐1 [NCT03349060] and JADE MONO‐2 [NCT03575871]). Objectives: To evaluate the impact of abrocitinib on patient‐reported signs/symptoms, including sleep loss and quality of life among adolescents with moderate‐to‐severe AD. Methods: JADE TEEN, JADE MONO‐1 and JADE MONO‐2 were conducted in the Asia‐Pacific region, Europe and North America and included patients aged 12–17 years with moderate‐to‐severe AD and inadequate response to ≥ 4 consecutive weeks of topical medication or treatment with systemic therapy for AD. Patients were randomly assigned (1 : 1 : 1, JADE TEEN; 2 : 2 : 1, JADE MONO‐1/‐2) to receive once‐daily oral abrocitinib (200 or 100 mg) or placebo for 12 weeks in combination with topical therapy (JADE TEEN) or as monotherapy (JADE MONO‐1/‐2). Data from adolescent patients in JADE MONO‐1/‐2 were pooled for these analyses. Results: At week 12, more adolescents treated with abrocitinib (200 or 100 mg) vs. placebo achieved a ≥ 4‐point improvement from baseline in the Patient‐Oriented Eczema Measure in JADE TEEN (83.9% and 77.0% vs. 60.2%) and JADE MONO‐1/‐2 (83.0% and 69.4% vs. 43.5%) and a ≥ 6‐point improvement from baseline in the Children's Dermatology Life Quality Index in JADE TEEN (73.8% and 67.5% vs. 56.5%) and JADE MONO‐1/‐2 (70.0% and 57.1% vs. 19.0%). Significant improvements in SCORing Atopic Dermatitis Visual Analog Scale for sleep loss scores were demonstrated with abrocitinib vs. placebo at weeks 2‐12 in JADE TEEN and JADE MONO‐1/‐2. Conclusions: Patient‐reported signs/symptoms, including reduction of sleep loss and quality of life, were substantially improved with abrocitinib monotherapy or combination therapy relative to placebo in adolescents with moderate‐to‐severe AD. [ABSTRACT FROM AUTHOR]