Patient-reported outcomes favor roflumilast vs. vehicle in scalp, body psoriasis treatment
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Key takeaways:
- At week 8, roflumilast reduced itch in more patients compared with vehicle (65.3% vs. 30.3%).
- Patient-reported outcomes for scaling, itch or pain favored roflumilast over vehicle (19.6% vs. 7.1%).
New results, including patient-reported outcome data, from the phase 3 ARRECTOR trial show roflumilast foam 0.3% continues to improve scalp and body psoriasis in adults, Arcutis announced in a press release.
“These data from the ARRECTOR trial show once-daily topical roflumilast foam achieved early and significant improvements in psoriasis signs and symptoms on both the scalp and body, including in patients who have already failed standard-of-care topical steroids, suggesting investigational roflumilast foam may be an important topical treatment option,” Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, said in the release.
The study included 432 adults and adolescents aged 12 years and older of which 81.9% reported previous topical steroid usage and 58.5% reported inadequate response, intolerance or contraindication to such treatment.
The results, which were presented at the European Academy of Dermatology and Venereology (EADV) Congress in Berlin, showed roflumilast significantly reduced itch in a greater proportion of patients compared with vehicle (65.3% vs. 30.3%; P < .0001) at week 8 according to a 4-point change from baseline in the Scalp Itch-Numeric Rating Score.
Significantly more patients taking roflumilast vs. vehicle achieved S-IGA success (66.4% vs. 27.8%, P < 0.0001), B-IGA Success (45.5% vs. 20.1%, P < 0.0001) and PASI-75 (50.1% vs. 16.8%, P < 0.0001) at week 8.
Twenty-four hours following the first application, investigators observed a rapid and significant improvement in scalp itch (P = .0164).
According to the 16-item Psoriasis Symptom Diary questionnaire, 19.6% of roflumilast-treated patients reported a total score of 0 compared with 7.1% of vehicle-treated patients (P = .0012). Further, more of the roflumilast group vs. vehicle also reported scores of 0 for psoriasis-related scaling, itch and pain (P < .0001 for all).