The recent phase 3, multicenter, ADVANCE trial investigated the efficacy of apremilast (Otezla), an oral phosphodiesterase 4 (PDE4) inhibitor, in adults with mild to moderate plaque psoriasis.1 The treatment is currently approved by the U.S. Food & Drug Administration (FDA) to treat adults with active psoriatic arthritis, adults with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and adults with oral ulcers associated with Behçet’s disease.2
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The ADVANCE trial was randomized, placebo controlled and double blind. At week 16, the study’s primary endpoint, patients treated with 30 mg of apremilast twice daily had statistically significant improvements in the static Physician’s Global Assessment (sPGA) response compared with placebo-treated patients. (Note: Statistically significant improvement was defined as an sPGA score of clear  or almost clear , with at least a two-point reduction from baseline.)
Additionally at week 16, apremilast-treated patients showed statistically significant improvements, compared with placebo-treated patients, in multiple secondary endpoints. These secondary endpoints included at least a 75% improvement from baseline in the percent of affected body surface area (BSA), a change in total BSA score from baseline, and a change in Psoriasis Area and Severity Index total score from baseline.
The most common adverse events, which occurred in at least 5% of patients, were diarrhea, headache, nausea, nasopharyngitis and upper respiratory tract infection. The adverse events observed were consistent with the known safety profile of apremilast. Amgen, the treatment’s maker, plans to submit these data to the FDA for inclusion in apremilast’s prescribing information.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Amgen Inc. News release: Amgen announces positive top-line results from Otezla (apremilast) phase 3 ADVANCE study in mild to moderate plaque psoriasis. 2020 May 6.
- U.S. Food and Drug Administration. Prescribing information: Otezla. 2020 Apr 10.