Study: Roflumilast cream 0.15% Significantly Reduces Itch, Improves Quality of Life

10/24/2024

Key Takeaways:

  • In the phase 3 ZORYVE cream 0.15% provided rapid itch relief within 24 hours and improved atopic dermatitis symptoms.
  • Patient-reported outcomes, including SCORAD and POEM scores, improved significantly as early as Week 1.
  • ZORYVE cream was well-tolerated, with low rates of adverse events in both studies.

New data show that ZORYVE® (Roflumilast) cream 0.15% rapidly alleviates symptoms of atopic dermatitis (AD) and significantly improves patient-reported outcomes, including daily activity, sleep, and emotional well-being, according to Arcutis. 

The manufacturer announced in a press release that it will be presenting new patient-reported outcome data for roflumilast cream 0.15% at the American College of Allergy, Asthma, and Immunology (ACAAI) 2024 Annual Scientific Meeting. According to the manufacturer, the phase 3 INTEGUMENT-1 and -2 trials showed the cream resulted in rapid symptom relief for AD patients, and was associated with significant improvements in all measured efficacy endpoints. It also showed that roflumilast cream 0.15% significantly reduced itch within 24 hours of the first application; further improvements in skin symptoms, sleep quality, and emotional distress were reported as early as within one week. Specifically, of the patients treated with roflumilast cream 0.15%, 64.2% achieved a clinically meaningful improvement in SCORing AD (SCORAD) Total Score vs. 36.3% treated with vehicle by Week 1.

The cream also showed continued benefit at Week 4, with 46.2% of patients achieving significant improvement in SCORAD vs. 26.6% with vehicle. Improvements in Patient-Oriented Eczema Measure (POEM) and Dermatitis Family Impact (DFI) scores were also more significant in the roflumilast cream 0.15%group vs. vehicle. 

"When evaluating different treatment options for chronic skin conditions we often focus on the clinical efficacy outcomes, like disease clearance or reduction in symptoms like itch," said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis. "However, this is just one piece of the puzzle and it’s just as important to understand the improvement in other aspects of patients’ lives that are impacted by this chronic disease. We’re proud to share these data showcasing rapid improvement in patient reported outcomes, which translate to meaningful relief with roflumilast cream 0.15% for those with AD their families, and caregivers.”

Source: Arcutis press release. October 24, 2024. 

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