Amgen announced positive topline results from the phase 3 study of apremilast (Otezla®), a phosphodiesterase 4 (PDE4) inhibitor, for the treatment of adults with mild to moderate plaque psoriasis.
The multicenter, placebo-controlled, double-blind ADVANCE study evaluated the efficacy and safety of apremilast in 595 adult patients with mild to moderate plaque psoriasis. Patients were randomized to receive either apremilast 30mg orally twice daily or placebo for the first 16 weeks followed by all patients receiving apremilast in an open-label extension phase through week 32. The primary end point was the proportion of patients with static Physician’s Global Assessment (sPGA) response of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at week 16.
Results showed that apremilast met the primary end point achieving a statistically significant improvement in sPGA response at week 16 compared with placebo. In addition, the study met key secondary end points including at least 75% 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.
The safety profile of apremilast was consistent with that seen in previous trials. The most commonly reported adverse events (≥5%) 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.
“Many patients with mild to moderate plaque psoriasis who use topical therapies still have challenges managing their psoriasis,” said David M. Reese, MD, executive vice president of Research and Development at Amgen. “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.”
Otezla is currently approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, and for oral ulcers associated with Behçet’s disease. It is available in 10mg, 20mg, and 30mg tablets.
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