Recommended Citation
Eichenfield LF, Stein Gold LF, Chiesa Fuxench ZC, Venturanza ME, Ren H, and Brar KK. 34794 Long-term safety and disease control of ruxolitinib cream among Black or African American patients with atopic dermatitis: Pooled results from 2 phase 3 studies. J Am Acad Dermatol 2022; 87(3):AB180.
Document Type
Conference Proceeding
Publication Date
9-1-2022
Publication Title
J Am Acad Dermatol
Abstract
Atopic dermatitis (AD) is an inflammatory skin disease with a prevalence in the United States of approximately 20%/5%–10% in Black or African American children/adults. In 2 phase 3 studies (TRuE-AD1/TRuE-AD2), 1249 patients (≥12 years old, Investigator’s Global Assessment [IGA] score 2/3, 3%–20% affected body surface area [BSA]) were randomized (2:2:1) to twice-daily 0.75% ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream, 1.5% ruxolitinib cream, or vehicle for an 8-week, double-blind vehicle-controlled period, followed by a double-blind long-term safety period (LTS; as-needed treatment; assessments every 4 weeks) up to Week 52. Patients initially randomized to ruxolitinib remained on their regimen during the LTS; patients initially on vehicle were rerandomized to either ruxolitinib strength. During the LTS, patients treated areas with active AD only, stopped treatment 3 days after lesion clearance, and restarted treatment at recurrence. Among self-identifying Black or African American patients in the 0.75%/1.5% ruxolitinib groups for the full study in this pooled analysis (n = 91/n = 97), 53.8%/61.9% achieved clear/almost clear skin (IGA 0/1) at Week 8. From Week 12–52, 55.2%–73.3%/59.3%–78.7% of patients (range) achieved IGA 0/1. Mean affected BSA was 8.6%/8.3% at baseline, 3.8%/3.6% at Week 8, and 1.7%–3.3%/1.3%–2.5% (range of mean values) through Week 52. Over 52 weeks, treatment-emergent adverse events were reported in 59.3%/56.7% of patients; treatment-related adverse events were reported in 4.4%/6.2%. Incidence of application site reactions was low. In summary, the majority of Black or African American patients achieved clear/almost clear skin using ruxolitinib cream monotherapy, which was well tolerated.
Volume
87
Issue
3
First Page
AB180
