Apremilast (Otezla, Amgen) significantly improved psoriasis symptoms compared with a placebo in adults with mild-to-moderate disease, according to top-line results from a phase 3 clinical trial.
Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 specific for cyclic adenosine monophosphate. It is currently FDA-approved for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis, and adults with oral ulcers associated with Behçet’s Disease.
The phase 3 ADVANCE study is a multicenter, randomized, placebo-controlled, double-blind trial that assessed the efficacy and safety of apremilast in adults with mild-to-moderate plaque psoriasis. A total of 595 patients were included and randomized to receive either oral apremilast 30 mg twice daily or placebo for the first 16 weeks, and all patients received treatment with apremilast during an open-label extension phase through week 32.
Treatment with apremilast 30 mg twice daily resulted in 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.
The study also met its secondary endpoints of achieving 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 were each also statistically significant for the treatment effect of apremilast compared with placebo.
“Many patients with mild-to-moderate plaque psoriasis who use topical therapies still have challenges managing their psoriasis,” David M. Reese, MD, executive vice president of Research and Development at Amgen, said in a statement. “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 (AEs) observed in the study were consistent with the known safety profile of apremilast. The most commonly reported AEs that occurred in at least 5% of patients in either treatment group were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection.
Data will be submitted to the FDA for inclusion in apremilast's prescribing information, Amgen said.
1. Amgen Announces Positive Top-Line Results From Otezla® (apremilast) Phase 3 ADVANCE Study In Mild-To-Moderate Plaque Psoriasis. News Release. Amgen; May 6, 2020. Accessed May 8, 2020. https://www.amgen.com/media/news-releases/2020/05/amgen-announces-positive-topline-results-from-otezla-apremilast-phase-3-advance-study-in-mildtomoderate-plaque-psoriasis/