Efficacy and Safety of Abrocitinib Versus Dupilumab in Patients Who Self-Identified as Having Skin of Color: A Post Hoc Analysis of JADE COMPARE

Abstract

Introduction Abrocitinib is efficacious and well-tolerated in patients with moderate-to-severe atopic dermatitis (AD). Clinical presentations of AD and treatment outcomes may vary in patients with skin of color (SoC). This study assessed short-term efficacy and safety of abrocitinib versus dupilumab in patients with SoC and moderate-to-severe AD in the phase 3 study, JADE COMPARE (NCT03720470). 

Methods This post hoc analysis included data from patients aged ≥18 years who were randomly assigned 2:2:2:1 to receive abrocitinib (200 mg/100 mg), dupilumab 300 mg, or placebo with concomitant topical therapy for 16 weeks. Patients who self-reported their race as non-White or did not report their race but identified as Hispanic or Latino were categorized as having SoC. Data are reported with non-responder imputation.  

Results Of 837 patients in JADE COMPARE, 227 (27.1%) were categorized as having SoC and 610 (72.9%) were categorized as White. The proportions of patients achieving efficacy responses, including a ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75), an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) (IGA 0/1), a ≥4-point improvement from baseline in the Peak Pruritus Numerical Rating Scale score (PP-NRS 4; used with permission from Regeneron Pharmaceuticals, Inc., and Sanofi), the high-threshold composite endpoint of ≥90% improvement from baseline in the EASI plus PP-NRS score of 0 or 1 (EASI-90 + PP-NRS 0/1),and a Dermatology Life Quality Index score of 0 or 1 (DLQI 0/1), were generally higher or comparable with abrocitinib versus dupilumab starting as early as Week 2 through Week 16; similar results were observed between treatment groups for patients with SoC and White patients. Adverse events including herpes zoster were more frequent with abrocitinib versus dupilumab or placebo in both patient subgroups, although overall frequency of herpes zoster was low. Treatment emergent adverse events in the placebo, abrocitinib 100 mg, abrocitinib 200 mg, and dupilumab 300 mg groups were reported in 57.1%, 57.1%, 66.2%, and 48.4% of patients with SoC and 51.7%, 48.9%, 60.2%, and 50.6% of White patients, respectively.  

Conclusions Greater proportions of patients with SoC and White patients achieved efficacy responses with abrocitinib versus dupilumab as early as Week 2 of treatment. The safety profiles of abrocitinib and dupilumab were consistent with previous analyses of the overall population from JADE COMPARE.