Roflumilast foam improves quality of life in patients with seborrheic dermatitis
Click Here to Manage Email Alerts
Key takeaways:
- Patients with seborrheic dermatitis treated with roflumilast foam 0.3% had a significant quality of life improvement.
- More patients treated with roflumilast vs. vehicle achieved a DLQI score of 0 or 1.
Treatment with roflumilast foam was associated with a significant improvement in quality of life for patients with seborrheic dermatitis, according to a poster presented at the Academy of Managed Care Pharmacy Nexus meeting.
“Seborrheic dermatitis can have an impact on a patient’s quality of life, from dealing with itchy, uncomfortable or visibly flaky skin, to embarrassment or inability to participate in social activities,” David Chu, PhD, FAAD, vice president of clinical development at Arcutis and one of the study’s investigators, told Healio. “Treatment of seborrheic dermatitis can make a significant impact in improvement in patients’ quality of life.”
The STRATUM phase 3 clinical trial evaluated the safety and efficacy of roflumilast foam 0.3% in 430 adult patients with seborrheic dermatitis using the Daily Life Quality Index (DLQI) score and the Cohoran-Natel-Haenszel test.
Patients were included if they had an IGA score of at least 3 on the 5-point scale and a body surface area involvement of up to 20%. They were randomly assigned 2:1 to receive roflumilast foam 0.3% or vehicle foam for eight weeks.
At week 2, DLQI scores were reduced by 48.81% in the treatment group, compared with 17.23 in the vehicle group (P < .0001). At weeks 4 and 8, these results continued with reductions of 52.86% and 61.74% in the treatment group, compared with reductions of 33.31% and 45.2% in the vehicle group.
A significant increase in the odds of achieving minimal clinically important difference, or a reduction of at least 4 points from baseline in DLQI, was also observed in the treatment arm at all points.
Additionally, a DLQI score of 0 or 1 was achieved by 37.1% of the roflumilast group at week 2 compared with 23.6% of the vehicle group. At weeks 4 and 8, 46.8% and 63.4% of the treatment arm reached this milestone, compared with 33.3% and 39.6% of those in the vehicle arm.
“These results demonstrate that as early as week 2, treatment with roflumilast foam 0.3% can improve quality of life in patients with seborrheic dermatitis, with improvements sustained through Week 8,” Chu told Healio. “Thus, roflumilast foam 0.3%, if approved, may provide a treatment for patients with seborrheic dermatitis that can result in a rapid and sustained impact on their quality of life.”
Collapse
Chu D. et al. Poster. Effect of roflumilast foam 0.3% on quality of life in patients with seborrheic dermatitis: patient-reported outcomes from the STRATUM phase III trial. Presented at: AMCP Nexus; Orlando.
Read more about
Click Here to Manage Email Alerts