Patient-Reported Outcomes for Roflumilast Foam Highlighted for Seborrheic Dermatitis

David H. Chu, MD, PhD, FAAD

Credit: Arcutis Biotherapeutics

Roflumilast foam 0.3% treatment of seborrheic dermatitis shows a significantly larger Dermatology Life Quality Index (DLQI) score improvement as early as Week 2 compared to vehicle, new findings suggest, and such improvements may be maintained through to the 8-week mark.¹

These conclusions as well as others resulted from recent findings from the phase 3 STRATUM trial, with the poster data presented at the Fall Clinical Dermatology Conference in Las Vegas. The poster was titled ‘Effect of Roflumilast Foam 0.3% on Quality of Life in Patients With Seborrheic Dermatitis: Patient-Reported Outcomes From the STRATUM Phase 3 Trial.’^1,2

The research was authored by such investigators as David David H. Chu, MD, PhD, FAAD, dermatologist and vice president of clinical development at Arcutis Biotherapeutics. Chu and colleagues had assessed the safety and efficacy of roflumilast foam 0.3% using the DLQI’s 10 questions regarding the perceived effect of skin disease on quality of life.

“This analysis evaluated DLQI data collected from STRATUM patients aged ≥ 17 years with moderate-to-severe (seborrheic dermatitis),” Chu et al. wrote. “Patients received roflumilast foam 0.3% or vehicle foam once daily for 8 weeks.”¹

Notes on Trial Design

Lower scores, especially a score of 0 or 1, were noted by the team as corresponding with minimal or no impact on one’s life quality. Additionally, a reduction of 4 points or more is known to suggest clinically meaningful change for inflammatory skin conditions.

Participants of the study who were included were aged 17 years and older and were required to have moderate-to-severe seborrheic dermatitis. They would apply either roflumilast foam 0.3% or vehicle foam on a once-per-day dosing regimen over the course of the study’s 8 weeks. The investigators assessed patient-reported outcomes using several endpoints, including the percent change from baseline in subjects’ DLQI scores.

They also looked at successful achievement of a minimal-clinically important difference, which was defined as at least a 4-point reduction for those with baseline scores over 4. Additionally, the research team looked at achievement of a DLQI score of 0 or 1 for those beginning with scores above 1.

The 2, 4, and 8-week outcomes were compared by the team between the roflumilast and vehicle cohorts. The investigators used the Cochran–Mantel–Haenszel test to identify distinctions in binary endpoints, but their analysis of covariance (ANCOVA) was implemented to assess DLQI score shifts from the point of baseline.

Notable Findings for Patient-Reported Outcomes

There were 430 individuals included in the team’s analysis, with 140 for vehicle and 290 for roflumilast. The investigators determined that at each of the aforementioned time points, the percent change from baseline in subjects’ DLQI was shown to be significantly larger for the roflumilast arm relative to vehicle arm.

At Week 2, the changes were as follows: –48.81 versus –‍17.23; P < .0001. At Week 4, –52.86 versus –‍33.81; P = .0011. At Week 8, –‍61.74 versus –‍45.20; P = .0065. Compared to those given the vehicle, roflumilast foam therapy was noted as significantly raising the odds of participants’ achievement of an MID in DLQI at the 2, 4, or 8-week marks (OR: 3.18; 95% CI: 2.19–‍4.62; P < .0001).

The research team found that roflumilast also led to significantly increase in the odds of subjects’ achievement of a DLQI 0/1 compared with the vehicle arm at the 2, 4, or 8-week marks (OR: 2.07; 95% CI: 1.56–‍2.75; P < .0001). The roflumilast foam 0.3% cohort had, relative to vehicle, a significantly higher likelihood of meaningful improvement in life quality.

The investigators noted that the rapid and sustained effects of roflumilast foam 0.3% on STRATUM participants’ life quality levels should be taken into consideration by providers and healthcare decision-makers in moments of treatment option assessment for seborrheic dermatitis.

References

1. ^{Chu D, Stephenson B, Zirwas M, et al. Effect of Roflumilast Foam 0.3% on Quality of Life in Patients With Seborrheic Dermatitis: Patient-Reported Outcomes From the STRATUM Phase 3 Trial. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vegas, Nevada. 24-27 October.}
2. ^{Arcutis Biotherapeutics. Journal of the American Academy of Dermatology publishes ZORYVE (roflumilast) foam, 0.3% results for seborrheic dermatitis from pivotal phase 3 trial. Arcutis Biotherapeutics. January 29, 2024. https://investors.arcutis.com/news-releases/news-release-details/journal-american-academy-dermatology-publishes-zoryve. Accessed: October 26, 2024.}