Phase 2 Study Results: Ruxolitinib Cream for Mild-to-Moderate HS

3 June 2024
A recent Phase 2 clinical trial has shown promising results in the treatment of mild-to-moderate hidradenitis suppurativa (HS), a chronic skin condition characterized by painful nodules and abscesses. The study, which was conducted using ruxolitinib cream 1.5% (Opzelura®), demonstrated a significant reduction in the count of abscesses and inflammatory nodules in patients treated with the cream compared to those using a vehicle control.

The trial's primary endpoint was met, with a notable decrease in the number of abscesses and nodules at week 16 for those using ruxolitinib cream 1.5%. The study also revealed that a substantial majority of patients on the treatment achieved at least a 50% reduction in nodule count, with a significant number achieving higher levels of reduction.

The findings were presented at the American Academy of Dermatology (AAD) Annual Meeting, where experts highlighted the potential of ruxolitinib cream for individuals with milder forms of HS, a condition that currently lacks approved therapies and often sees inadequate standard care.

The study's secondary endpoints included various measures of improvement, such as the Hidradenitis Suppurativa Clinical Response (HiSCR) and the International Hidradenitis Suppurativa Severity Score System (IHS4). Patients treated with ruxolitinib cream also reported a reduction in skin pain and itchiness.

Importantly, the cream was found to be generally well-tolerated, with treatment-emergent adverse events occurring at a similar or lower rate than in the control group. The most common adverse events were mild and included COVID-19 and nasopharyngitis.

HS is a debilitating condition that affects the quality of life for those who suffer from it. The successful results of this Phase 2 study offer hope for a new treatment option that could help manage the persistent symptoms of HS, particularly for those with milder forms of the condition.

Incyte, the company behind Opzelura, has a commitment to advancing dermatological treatments, focusing on the JAK-STAT pathway for conditions with significant unmet medical needs. The positive outcomes of this trial align with Incyte's mission to develop innovative solutions for patients.

While the study's results are encouraging, further research is necessary to fully understand the impact of ruxolitinib cream on skin pain and itchiness in patients with HS. The study's findings are a step forward in the ongoing search for effective therapies for this challenging skin condition.

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