Incyte Announces New Findings from Pooled Analyses of the Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream in Patients with Atopic Dermatitis - Seite 2

• 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.