Incyte Announces New Findings from Pooled Analyses of the Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream in Patients with Atopic Dermatitis

Incyte (Nasdaq:INCY) today announced findings from three pooled analyses of its randomized, double-blind, vehicle-controlled Phase 3 studies – TRuE-AD1 and TRuE-AD2 – evaluating ruxolitinib cream, an investigational JAK1/JAK2 inhibitor designed for topical application, as a treatment for patients with atopic dermatitis (AD). These presentations (Posters #27716, #27620 and #26887) will be available on demand as part of the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX), held virtually April 23–25, 2021.

Positive topline results from the individual TRuE-AD1 and TRuE-AD2 studies were previously reported. Efficacy and safety results from a pooled analysis of TRuE-AD1 and TRuE-AD2 were also announced and presented at the 29th European Academy of Dermatology and Venereology (EADV) Congress in October 2020. The primary and secondary endpoints were met in both TRuE-AD1 and TRuE-AD2.

New findings from the analyses being presented at AAD VMX add to the growing body of evidence on ruxolitinib cream as a potential treatment for AD.

One analysis (Poster #27716) assessed patient response to ruxolitinib cream across several clinical characteristics, including baseline Investigator’s Global Assessment (IGA) score (2 or 3), Eczema Area Severity Index (EASI) score (≤7 or >7), itch numerical rating scale (NRS) score (<4 or ≥4) and affected Body Surface Area (BSA) (<10% or ≥10%; patients with ≥10% BSA are typically classified as having more severe AD).

• Ruxolitinib cream 0.75% applied twice daily (BID) and ruxolitinib cream 1.5% BID both demonstrated greater improvement compared to vehicle in all analyzed efficacy endpoints (i.e., IGA Treatment Success [IGA-TS], the proportion of patients achieving at least a 50%, 75% or 90% improvement from baseline in the EASI score [EASI-50, EASI-75, EASI-90] and the proportion of patients with at least a 4-point improvement in the itch NRS [NRS4]) at Week 8, regardless of clinical characteristic subgroup.
• Higher responses were observed in patients with more severe disease (e.g., baseline BSA ≥10%).

A subsequent analysis (Poster #27620) looked specifically at patients in TRuE-AD1 and TRuE-AD2 with BSA ≥10% and EASI ≥16 at baseline, criteria that have been used in clinical studies with systemic therapies to identify patients with more severe AD. It found higher rates of clinical responses with ruxolitinib cream versus vehicle in these patients, and results were similar using different definitions for more severe AD (i.e., IGA=3; IGA=3 and EASI ≥16; IGA=3, EASI ≥16 and BSA ≥10%; and IGA=3, EASI ≥16, BSA ≥10% and itch NRS ≥4). Specifically: