‘A valuable treatment’: Roflumilast foam 0.3% shows positive PROs in scalp, body psoriasis
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Key takeaways:
- Scalp-IGA (66.4% vs. 27.8%) and body-IGA (45.5% vs. 20.1%) success was achieved by more roflumilast- vs. vehicle-treated patients.
- Roflumilast-treated patients also reported an improvement in quality of life.
Roflumilast foam 0.3% improved patient-reported outcomes in scalp and body psoriasis, according to a poster presentation at the Fall Clinical Dermatology Conference.
In the phase 3, parallel-group, double-blind, vehicle-controlled ARRECTOR trial, patients aged 12 years and older with moderate to severe scalp and body psoriasis were randomly assigned to receive roflumilast foam 0.3% (Zoryve, Arcutis; n = 281) or vehicle foam (n = 151) daily for 8 weeks, and while efficacy outcomes were evaluated, the investigators paid special attention to patient-reported outcomes.
“What we learned from this study overall is that the foam version of roflumilast, or Zoryve foam, is going to be a valuable treatment option for patients in that we not only see rapid and significant improvement in the clinical assessments of psoriasis symptoms, but we also see that from the patient’s viewpoint and in the patient reported outcomes,” Melinda J. Gooderham, MSc, MD, medical director of the SKiN Center for Dermatology, investigator with Probity Medical Research and assistant professor at Queen’s University, Peterborough, Ontario, Canada, told Healio.
In the study, a higher proportion of roflumilast-treated vs. vehicle-treated patients had better efficacy outcomes in scalp-IGA success (66.4% vs. 27.8%), scalp-IGA of clear (40% vs. 9.1%), body-IGA success (45.5% vs. 20.1%) and body-IGA clear (27.8% vs. 11%; P < .001 for all), respectively, by week 8 — findings that Gooderham stated “pleasantly surprised” her.
“The scalp is notoriously difficult to treat,” she said. “So, to see the scalp IGA success up to 66% and the body IGA success higher than with the cream was just a nice surprise.”
When it came to patient-reported outcomes, roflumilast also outperformed vehicle with 52.3% of roflumilast-treated patients reaching a Scalp Itch Numeric Rating Scale score of 0 or 1 vs. 24.1% of vehicle-treated patients (P < .0001). Similarly, 55.4% of the roflumilast group vs. 19.8% of the vehicle group achieved 0 or 1 on the Worst Itch Numeric Rating Scale (P < .0001).
A higher percentage of roflumilast- vs. vehicle-treated patients also experienced a Psoriasis Scalp Severity Index (PSSI)-50 (83.9% vs. 45.6%), PSSI-75 (70.9% vs. 31.3%), PSSI-90 (52.7% vs. 14.9%) and PSSI-100 response (41.1% vs. 10.3%; P < .0001 for all).
Quality of life also improved significantly for these patients. According to the Scalpdex, a questionnaire used to measure the level of impact a dermatological disease has on a patient, the total impact psoriasis had on roflumilast-treated patients’ quality of life decreased by 23.4 points from baseline compared with 12.8 points in the vehicle group. More specifically, roflumilast vs. vehicle lowered the emotional (–23.1 vs. –12.4), symptomatic (–29 vs. –15) and functional (–20.7 vs. –11.7; P < .0001 for all) burden of scalp psoriasis on quality life.
As these results presented themselves over the span of only 8 weeks, Gooderham emphasized that the rapid improvement induced by roflumilast can improve adherence and, as a result, overall outcomes.
“I think every dermatologist hears every day, ‘Oh, I stopped using it because it wasn’t working,’” she said. “So, to have a product that they can feel the benefit of early on will encourage that ongoing adherence.”
In addition to its rapid efficacy, roflumilast foam 0.3%’s unique ability to treat both the scalp and body can have positive outcomes for patients.
“Part of the burden of psoriasis, in addition to the itching and clinical appearance, is treatment,” Gooderham told Healio. “So, to have one product that you can use on your body and your scalp once a day really reduces that portion of their burden. If you look at the larger picture, this is where I think Zoryve foam will make the biggest impact.”