Psoriasis (also called psoriasis) is a severe, chronic inflammatory disease that causes raised, red, scaly patches on the skin, usually affecting the elbows, knees, and the outside of the scalp, but can appear anywhere on the body. Approximately 125 million people worldwide have psoriasis, including approximately 14 million in Europe and more than 7.5 million in the United States. Approximately 80% of patients have plaque psoriasis, the most common form of the disease, and up to 63% of people with psoriasis have the genital area affected (at any time) during the course of the disease.
On December 1, 2021, Amgen announced positive top-line results from the DISCREET trial. The DISCREET trial is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy of Otezla® (apremilast) in the treatment of moderate to severe genital psoriasis and moderate to severe plaque psoriasis. The study showed that oral Otezla 30 mg twice daily achieved clinically meaningful and statistically significant improvements in the primary endpoint of modified static physician global assessment (sPGA-G) response at week 16 compared with placebo.
Additionally, all secondary endpoints were meaningful and significant improvements in Genital Psoriasis Numerical Rating Scale (GPI-NRS) response, change from baseline in affected body surface area (BSA), change from baseline in Dermatology Life Quality Index (DLQI), and static Physician Global Assessment (sPGA) response at Week 16 compared to placebo.
The type and incidence of adverse events observed in this trial were consistent with Otezla's known safety profile. The most common adverse events (≥5%) were diarrhea, headache, nausea, and nasopharyngitis.
Patients who completed the double-blind phase of the trial continued or switched to Otezla during the expansion phase and received treatment through week 32. The study is ongoing and scheduled to be completed in the first half of 2022.
In the United States, Otezla is approved for the treatment of adults with moderate-to-severe plaque psoriasis (treatable with phototherapy or systemic therapy), active psoriatic arthritis, and oral ulcers associated with Behçet disease. Since first receiving FDA approval in 2014, Otezla has been used in more than 650,000 patients worldwide with moderate to severe plaque psoriasis, active psoriatic arthritis, or Behçet's disease.
References:
https://www.amgen.com/newsroom/press-releases/2021/12/amgen-announces-positive-topline-results-from-otezla-apremilast-phase-3-discreet-study-in-moderate-to-severe-genital-psoriasis
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