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

Abstract

BackgroundA 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]).ObjectivesTo evaluate the impact of abrocitinib on patient‐reported signs/symptoms, including sleep loss and quality of life among adolescents with moderate‐to‐severe AD.MethodsJADE 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.ResultsAt 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.ConclusionsPatient‐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.