Does Baseline Severity of Atopic Dermatitis Impact the Long-Term Efficacy of Abrocitinib? Post-hoc Analysis of Two Randomized Trials

INTRODUCTION: Baseline severity of atopic dermatitis (AD) may influence treatment response. The objective of this analysis was to assess short- and long-term abrocitinib efficacy and safety by baseline AD severity. METHODS: A post-hoc analysis of patients (aged ≥ 12 years) with moderate-to-severe AD receiving abrocitinib 100 mg or 200 mg or placebo in two studies-JADE COMPARE (ClinicalTrials.gov ID: NCT03720470) and JADE EXTEND (NCT03422822)-was performed. Baseline severity was assessed by several measures, including the Investigator's Global Assessment (IGA) and the Eczema Area and Severity Index (EASI). Efficacy and safety endpoints were stratified by baseline severity. RESULTS: Higher proportions of patients with moderate or severe baseline AD achieved IGA score 0/1 (clear/almost clear) with abrocitinib at week 16 (moderate: 40.8% [100 mg], 50.0% [200 mg]; severe: 19.1% [100 mg], 43.2% [200 mg]) versus placebo (moderate: 18.0%; severe: 2.8%). At week 112, IGA 0/1 was achieved by high proportions of patients receiving abrocitinib with moderate (60.2% [100 mg], 64.3% [200 mg]) or severe (38.6% [100 mg], 54.5% [200 mg]) disease. Response rates were similar with other measures, including co-achievement of EASI-90 (90% improvement from baseline score) and Peak Pruritus Numerical Rating Scale 0/1 (no itch/mild itch). There were no new safety signals. CONCLUSION: Abrocitinib demonstrated early and sustained improvement in skin clearance and itch through week 112 in adult and adolescent patients, and sustained responses were observed in patients in the moderate and severe baseline AD subgroups. CLINICAL TRIALS REGISTRATION: This study was a pooled analysis of data from the phase 3 JADE COMPARE (NCT03720470) and JADE EXTEND (NCT03422822) trials.