Patients With Moderate-to-Severe Atopic Dermatitis Maintained Depth of Response Up to 2 Years With Continuous Abrocitinib Treatment
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Keywords
Abrocitinib, atopic dermatitis, flare activity
Abstract
Introduction: Patients with moderate-to-severe atopic dermatitis (AD) have a longitudinal disease course with fluctuating AD severity over time, and static assessments may not accurately capture disease severity. The oral Janus kinase 1-selective inhibitor, abrocitinib, is approved for the treatment of adolescents and adults with moderate-to-severe AD in multiple regions. The goal of this study was to assess the frequency of breakthrough disease flare activity and the severity of any such flare activity in patients receiving continued abrocitinib treatment.
Procedure/Study: Data were included from patients receiving abrocitinib (200 mg/100 mg) or placebo as monotherapy or in combination with topical therapy in phase 2a and 3 trials and enrolled in the ongoing extension study, JADE EXTEND (NCT03422822; data cutoff: 5 September 2022) and who achieved response criteria (Investigator’s Global Assessment score of 0 or 1 with ≥2 points improvement from baseline [IGA 0/1] or ≥75% improvement from baseline in Eczema Area and Severity Index [EASI-75]) at Week 16. Assessments included the proportion of patients from Week 16 in the long-term efficacy pool who maintained response for EASI-75, ≥4-point improvement from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS4; used with permission from Regeneron Pharmaceuticals, Inc., and Sanofi), ≥4-point improvement from baseline in Dermatology Life Quality Index (DLQI-4) and ≥6-point improvement from baseline in Children’s Dermatology Life Quality Index (CDLQI-6) to 116 weeks at 80% and 100% of visits, respectively. Missing data were handled with nonresponder imputation.
Results: Overall, 663 and 361 patients received abrocitinib 200-mg and 100-mg and met the response criteria at Week 16. Substantial proportions of patients receiving abrocitinib at either dose maintained response at 80% of visits to Week 116 for EASI-75 (200 mg: 62.3%, 100 mg: 52.6%), PP-NRS4 (47.1%, 35.5%), and patient-reported outcomes DLQI-4 (61.1%, 53.4%) and CDLQI-6 (57.6%, 40.0%). A notable proportion of patients receiving abrocitinib at either dose maintained response without flare for 100% of visits.
Conclusion: Most patients did not experience frequent breakthrough flare activity with continuous abrocitinib treatment up to Week 116.
Funding/Disclosures: This study was funded by Pfizer.
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