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In 2 recent phase 3 trials, safety and efficacy was proven in the use of roflumilast cream 0.3% for the treatment of plaque psoriasis.
The Journal of the American Medical Association (JAMA) has published positive results from 2 phase 3 trials on the use of roflumilast cream 0.3%(ZORYVE; Arcutis Biotherapeutics, Inc) once per day to treat chronic plaque psoriasis.
Results from the trials showed that ZORYVE led to significant improvements in plaque clearance and itch after 8 weeks in adults and children with plaque psoriasis, with Investigator Global Assessment (IGA) being used to measure success.
Mark Lebwohl MD, FAAD, discussed how plaque psoriasis and the itching that accompanies the condition negatively affects patients’ quality of life. The results from the phase 3 trials indicate that ZORYVE can greatly reduce sores and loss of sleep from itch caused by plaque psoriasis. Also, Lebwohl noted, ZORYVE quickly cleared plaques in cases of varying severity.
The two trials were identical phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies. Participants were aged 2 years and above, and had mild, moderate, or severe chronic plaque psoriasis which covered 2% to 20% of their body surface area.
Once a day, participants applied ZORYVE to the affected area, over the course of 8 weeks. In a control group, a vehicle was applied instead of ZORYVE. IGA success after 8 weeks was seen in many more patients using ZORYVE than those using a vehicle.
Improvements in itch began as early as week 2, progressing through week 8. Patients with significant itch saw a 4-point reduction measured by a Worst Itch Numerical Rating Scale. ZORYVE also saw significant success in treating intertriginous areas, often achieving IGA success by week 8.
Signs and symptoms were significantly improved in patients, and safety and tolerability of the cream were similar to vehicle. No serious adverse events occurred.
Journal of the American Medical Association publishes roflumilast cream 0.3% results from pivotal DERMIS-1 and -2 phase 3 trials in plaque psoriasis. Arcutis Biotherapeutics. Accessed September 23, 2022. https://www.arcutis.com/journal-of-the-american-medical-association-publishes-roflumilast-cream-0-3-results-from-pivotal-dermis-1-and-2-phase-3-trials-in-plaque-psoriasis/