Incyte announces new data from Phase 2 study evaluating ruxolitinib cream

Incyte announced new results from a Phase 2 study evaluating the efficacy and safety of twice-daily ruxolitinib cream 1.5% in adult patients with Hurley stage 1 or 2 hidradenitis suppurativa. These data were presented as a late-breaking oral presentation at the American Academy of Dermatology Annual Meeting, held from March 8-12, 2024, in San Diego. The study met its primary endpoint, demonstrating a significantly greater reduction in abscess and inflammatory nodule count in patients treated with ruxolitinib cream 1.5%, compared to those who applied the vehicle control at Week 16. More than three quarters of on-treatment patients achieved at least a 50% reduction in AN count, 54.2% achieved a 75% reduction, 20.8% achieved 90% reduction, and 20.8% achieved complete clearance, surpassing the 56.3%, 25.0%, 12.5% and 12.5% reductions, respectively, in the vehicle control group. The majority of patients in the ruxolitinib cream 1.5% group met the criteria for Hidradenitis Suppurativa Clinical Response, which indicates a 50% or greater reduction in AN count without an increase in abscesses or draining fistulas, compared to 50.0% of patients in the vehicle control group. Patients treated with ruxolitinib cream 1.5% showed a greater mean reduction in the International Hidradenitis Suppurativa Severity Score System score compared to baseline at Week 16 compared to the vehicle group. Patients treated with ruxolitinib cream 1.5% showed a change -1.85 and -1.42 from baseline in the Skin Pain Numeric Rating Scale and Itch NRS at Week 16, respectively, versus a -2.61 and -2.75 change from those in the vehicle control group. Due to patient eligibility criteria, patients studied did not have high itch or skin pain scores at baseline; however, additional research is needed to evaluate treatment impact on skin pain and itch scores. The study results showed that ruxolitinib cream 1.5% was generally well-tolerated. Treatment-emergent adverse events occurred in 38.2% of patients who applied ruxolitinib cream 1.5% versus 42.9% of patients who applied vehicle control. The most common TEAEs among patients receiving ruxolitinib cream 1.5% were COVID-19 and nasopharyngitis. Discontinuation due to TEAEs were infrequent, and no serious TEAEs were reported in the ruxolitinib cream 1.5% group.