Incyte announced new results from a Phase 2 study evaluating the efficacy and safety of twice-daily ruxolitinib cream 1.5% (Opzelura®) in adult patients with Hurley stage 1 or 2 (mild-to-moderate) hidradenitis suppurativa (HS). These data were presented as a late-breaking oral presentation (Session: S050 ? Late-Breaking Research: Session 2) at the American Academy of Dermatology (AAD) 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 (AN) count in patients treated with ruxolitinib cream 1.5%, compared to those who applied the vehicle control (least squares mean change of -3.61 for ruxolitinib cream 1.5% vs. -2.42 for vehicle control; P<0.05) at Week 16. Additional secondary endpoints of the study included: More than three quarters (79.2%) of on-treatment patients achieved at least a 50% reduction in AN count (AN50), 54.2% achieved a 75% reduction (AN75), 20.8% achieved 90% reduction (AN90), and 20.8% achieved complete clearance (100% reduction, AN100), surpassing the 56.3%, 25.0%, 12.5% and 12.5% reductions, respectively, in the vehicle control group.

The majority (79.2%) of patients in the ruxolitinib cream 1.5% group met the criteria for Hidradenitis Suppurativa Clinical Response (HiSCR), 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 (IHS4) score compared to baseline at Week 16 (-4.46) compared to the vehicle group (-2.66). Patients treated with ruxolitinib cream 1.5% showed a change -1.85 and -1.42 from baseline in the Skin Pain Numeric Rating Scale (NRS) 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 (TEAEs) 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 (5.9%) and nasopharyngitis (5.9%). Discontinuation due to TEAEs were infrequent (ruxolitinib cream 1.5%, n=2 [5.9%]; vehicle control, n=0 [0%]), and no serious TEAEs were reported in the ruxolitinib cream 1.5% group. This randomized, double-blind, vehicle-controlled Phase 2 clinical trial is designed to evaluate the safety and efficacy of ruxolitinib cream 1.5% (Opzelura®) in patients with mild-to-moderate hidradenitis suppurativa (HS).

The study enrolled 69 adult patients (age = 18 years) diagnosed with Hurley stage 1 or 2 HS who have a total abscess and inflammatory nodule (AN) count of 3 to = 10, with no draining tunnels at screening and baseline visits. The primary outcome measure of the study is change from baseline in AN count at Week 16. Secondary outcome measures include proportion of participants achieving reduction in AN count relative to baseline, change from baseline in the Skin Pain Numeric Rating Scale (NRS), change from baseline in the itch NRS score, proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR), change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) score and number of TEAEs.

Opzelura, a novel cream formulation of Incyte?s selective JAK1/JAK2 inhibitor ruxolitinib, is approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, and is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

Opzelura and the Opzelura logo are registered trademarks of Incyte. OPZELURA is for use on the skin only. Do not use OPZELURA in eyes, mouth, or vagina.

OPZELURA may cause serious side effects, including: Serious Infections: OPZELURA contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect immune system.

JAK inhibitors can lower the ability of immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections.

Some people have had serious infections of their lungs while taking OPZELURA. healthcare provider should watch closely for signs and symptoms of TB during treatment with OPZELURA.