Amgen’s Otezla produces significant improvements in measures of mild-to-moderate psoriasis, compared with placebo, according to a top-line results from the ADVANCE trial.
ADVANCE is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla (apremilast) in adults with mild-to-moderate plaque psoriasis. The study showed that oral Otezla 30 mg twice daily achieved a statistically significant improvement, compared with placebo, in the primary endpoint of the static Physician's Global Assessment (sPGA) response (defined as an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline) at week 16.
In addition, the week 16 secondary endpoints of achieving at least 75 percent improvement from baseline in the percent of affected body surface area (BSA); change in BSA total score from baseline; and change in Psoriasis Area and Severity Index (PASI) total score from baseline were each also statistically significant for the treatment effect of Otezla compared with placebo.
"Many patients with mild-to-moderate plaque psoriasis who use topical therapies still have challenges managing their psoriasis," says David M. Reese, M.D., executive vice president of Research and Development at Amgen, in a news release. “We look forward to discussions with the FDA about the potential to bring Otezla, which has already been prescribed to hundreds of thousands of patients with moderate-to-severe psoriasis, to more patients who may need additional therapeutic options."
The adverse events observed in this trial were consistent with the known safety profile of Otezla. The most commonly reported adverse events that occurred in at least 5 percent of patients in either treatment group were diarrhea, headache, nausea, nasopharyngitis and upper respiratory tract infection.
Detailed results will be submitted for presentation at an upcoming medical meeting.