Impact of Roflumilast Foam 0.3% on Patient-Reported Quality of Life in Seborrheic Dermatitis: An Analysis of Stratum Data for Patients Unresponsive or Intolerant to Topical Corticosteroids
Chu DH1, Stephenson B2, Lee J3, Bannister B3, Hickey C3, Westley T3, Zirwas M4
1Arcutis Biotherapeutics, Inc, Westlake Village, CA, USA, 2Arcutis Biotherapeutics, Inc, SAN FRANCISCO, CA, USA, 3Lumanity, Bethesda, MD, USA, 4Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley, OH, USA
OBJECTIVES: Roflumilast foam 0.3% (roflumilast) has demonstrated efficacy and tolerability in STRATUM. a Phase 3 clinical trial of patients with moderate-to-severe seborrheic dermatitis (SD). Our aim was to assess the quality of life (QOL) impact of roflumilast versus vehicle in patients who reported an inadequate response, intolerance, or contraindication to topical corticosteroids (TCS).
METHODS: Baseline and follow-up Dermatology Life Quality Index (DLQI) data from the STRATUM trial were collected for patients aged ≥17 years with moderate-to-severe SD who had an inadequate response, intolerance, or contraindication to TCS. Patient-reported outcome (PRO) endpoints included percentage change from baseline in DLQI score and achievement of a minimal important difference (MID; defined as ≥4-point reduction in baseline DLQI score), for roflumilast versus vehicle at weeks 2, 4, and 8. Differences in change from baseline DLQI scores were assessed using the Kruskal-Wallis rank sum test. The Cochran–Mantel–Haenzel test was used to assess differences in the proportion of patients achieving binary endpoints between treatment arms in each subgroup.
RESULTS: 181 patients at baseline (125 roflumilast, 56 vehicle) were included in the subgroup analysis. At each time point, percentage change from baseline in DLQI score was significantly larger for roflumilast-treated patients relative to vehicle (Week 2: -45.65% (95% CI: -54.44%, -35.46%) vs -13.62% (-28.82%, 0.64%); p<0.001; Week 4: -55.35% (-64.88%, -42.38%) vs -25.08% (-37.25%, -12.21%); p<0.001; Week 8: -61.93% (-71.38%, -49.96%) vs -37.06% (-53.10%, -21.30%); p=0.001) Treatment with roflumilast significantly increased the odds of achieving an MID in DLQI from baseline to weeks 2, 4, or 8 (common odds ratio [OR]: 6.97; 95% confidence interval [CI]: 3.97, 12.24; p<0.001).
CONCLUSIONS: These results suggest that roflumilast provides significant and meaningful QOL benefits for moderate-to-severe SD patients with an inadequate response, intolerance, or contraindication to TCS.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Patient-reported Outcomes & Quality of Life Outcomes
No Additional Disease & Conditions/Specialized Treatment Areas, Sensory System Disorders (Ear, Eye, Dental, Skin)