Ortho Dermatologics: JAAD publishes results of Phase trials of DUOBRII
Ortho Dermatologics, a division of Valeant Pharmaceuticals, announced that the Journal of the American Academy of Dermatology published for the first time positive results from two Phase 3, multicenter, randomized, double-blind clinical trials (Studies 1 and 2) to assess the safety and efficacy of DUOBRIITM lotion in the treatment of plaque psoriasis.2 Studies 1 and 2, which enrolled a total of 418 patients, showed DUOBRII was consistently more effective than vehicle in achieving treatment success (defined as those with at least a two-grade improvement from baseline in an Investigator Global Assessment score, and 'clear' or 'almost clear' skin), demonstrating statistically significant superiority by week four (in Study 1) and week two (in Study 2). At week eight, 35.8% (Study 1) and 45.3% (Study 2) had achieved the primary efficacy outcome, compared to 7% and 12.5% on vehicle. The majority of patients maintained treatment success over the four-week post treatment period. DUOBRII was also superior in reducing psoriasis signs and symptoms and body surface area affected compared to vehicle. In addition, DUOBRII showed significant reductions in the severity of the clinical signs of psoriasis. The most common treatment-related adverse events were contact dermatitis (6.3%), application site pain (2.6%) and pruritus (2.2%).