Zoryve achieves plaque psoriasis improvement in 95% of patients
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Key takeaways:
- Of patients treated with Zoryve, 72.1% achieved PASI 50, 40.3% PASI 75, 19.7% PASI 90 and 12.3% PASI 100.
- Zoryve was well tolerated.
New phase 3 study data showed Zoryve cream 0.3% provided measurable improvement in psoriasis severity in nearly all treated individuals, Arcutis announced in a press release.
Zoryve (roflumilast), a steroid-free cream indicated for individuals with psoriasis aged as young as 6 years, was evaluated in two pivotal phase 3 studies, DERMIS-1 and DERMIS-2. Individual patient response data from these studies was presented at the 43rd Annual Fall Clinical Dermatology Conference.
“Data reported from clinical trials generally show results within the overall study population which is certainly important. However, what it does not show clinicians is the range or pattern of clinical response they can anticipate in the individual patient they are treating,” James Q. Del Rosso, DO, FAOCD, FAAD, research director and principal investigator, JDR Dermatology Research, and lead author on the individual patient response presentation, said in the release. “This information is clinically relevant during each office visit with every patient as it directly provides the range of individual patient responses, in this case using PASI scores as the measure of response.”
Results showed that 95% of individuals treated with roflumilast exhibited a measurable improvement in PASI at week 8. Specifically, 72.1% of patients treated with roflumilast achieved PASI 50 vs. 25.5% of those treated with vehicle (P < .0001).
Additionally, 40.3% of the roflumilast group achieved PASI 75 at week 8 vs. 6.5% of the vehicle group (P < .0001). PASI 90 and PASI 100 were also observed in 19.7% and 12.3% of roflumilast patients, respectively, compared with only 2.3% and 0.8% of vehicle patients at week 8 (P < .0001 and P < .001).
Roflumilast was deemed well tolerated from first application with patients reporting nearly no stinging and burning. A hot, tingling/stinging sensation was reported in 0.4% of roflumilast-treated patients vs. no vehicle-treated patients at first application, followed by 0% and 0.4% of the roflumilast group and 0.4% and 0% of the vehicle group at weeks 4 and 8, respectively.
Other adverse events included diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1%), upper respiratory tract infection (1%) and urinary tract infection (1%).
“Collectively, this information highlights the efficacy, consistency and importance of Zoryve cream as a corticosteroid-free topical treatment for the vast majority of children and adults with plaque psoriasis,” Del Rosso said.