Benzinga | Apr 23, 2021 10:02AM EDT

Incyte Reports New Findings From Pooled Analyses Of Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream In Patients With Atopic Dermatits

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:

* At Week 8, more patients achieved IGA-TS with ruxolitinib cream 0.75% and ruxolitinib cream 1.5% versus vehicle (50.0% and 59.4% versus 0%, respectively).

* More patients who applied ruxolitinib cream 0.75% and ruxolitinib cream 1.5% versus vehicle achieved EASI-50 (80.6% and 78.1% versus 38.5%), EASI-75 (75.0% and 71.9% versus 7.7%), and EASI-90 (52.8% and 46.9% versus 7.7%) at Week 8.

* At Week 8, more patients achieved itch NRS4 with ruxolitinib cream 0.75% and ruxolitinib cream 1.5% versus vehicle (50.0% and 61.1% versus 27.3%).

"We are pleased to have the opportunity to share additional analyses from the TRuE-AD program with the scientific community at AAD VMX as these data provide more insight into the needs of people living with AD and the impact ruxolitinib cream could have across patient subgroups," said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. "Specifically, the findings suggest ruxolitinib cream could be an effective treatment option for AD irrespective of patients' pre-treatment characteristics, and may be efficacious among those with more severe disease -- potentially delaying or preventing the need for systemic therapy in these patients. We look forward to furthering analyzing data from the TRuE-AD program in the hopes it will lead to a meaningful new option for patients living with this inflammatory skin condition, which can significantly impact patients' quality of life."

Finally, a third pooled analysis (Poster #26887) provided additional context regarding the impact of ruxolitinib cream on sleep quality and related impacts -- a key quality of life measure. It showed clinically-relevant improvement in sleep parameters in adolescents and adults with AD who received ruxolitinib cream as demonstrated by mean change from baseline in patient-reported outcomes tools. Specifically:

* At Week 8, more patients with Patient-Reported Outcomes Measurement Information System (PROMIS) sleep-related impairment (8a) and sleep disturbance (8b) scores ?14 at baseline who received ruxolitinib cream 0.75% or ruxolitinib cream 1.5% BID achieved a clinically meaningful ?6-point improvement versus vehicle (30.3% and 33.9% versus 20.3%; and 26.5% and 30.5% versus 17.9%, respectively).

* More patients who received ruxolitinib cream 0.75% or ruxolitinib cream 1.5% BID reported no nights of disturbed sleep versus vehicle (66.1% and 71.6% versus 44.3%) at Week 8, as assessed by Patient-Oriented Eczema Measure (POEM) item 2 (number of nights of disturbed sleep due to eczema over the past seven days).

* A greater reduction in mean change from baseline in Scoring Atopic Dermatitis (SCORAD) sleeplessness scores (indicating improved sleep quality) was reported in patients who received ruxolitinib cream compared with those who applied vehicle at Weeks 2, 4 and 8.

Across all analyses, the overall safety profile of ruxolitinib cream was consistent with previously reported data and no safety signals were observed.

"There is an urgent need for new treatment options that balance efficacy and tolerability for patients with atopic dermatitis," said Kim Papp, M.D., Ph.D., Founder and President of Probity Medical Research and the Coordinating Investigator for the TRuE-AD program. "I am thoroughly encouraged by findings from the TRuE-AD program, and the potential ruxolitinib cream could have for patients whose everyday lives are impacted by the itch and inflammation associated with their disease."

These presentations are available on demand on the AAD VMX website at https://eposters.aad.org/categories, and can be accessed until July 12, 2021.