Amgen Announces Positive Top-Line Results for Otezla® (apremilast) in Phase 3 ADVANCE Study for Mild-to-Moderate Plaque Psoriasis

Today, Amgen announced that in the Phase 3 ADVANCE study evaluating its oral therapy Otezla (apremilast) in patients with mild-to-moderate plaque psoriasis, the treatment demonstrated a statistically significant improvement in skin clearance, as measured by the static Physician’s Global Assessment (sPGA) at Week 16, compared with placebo.

Psoriasis is a chronic, inflammatory skin disease characterized by red patches covered with silvery scales, dryness, cracking, bleeding, and thickened, pitted, or raised nails. For patients with more severe symptoms, psoriasis significantly impacts their quality of life. According to statistics released in a press release, psoriasis affects nearly 3% of the global population, with approximately 125 million patients worldwide. Despite progress in drug development in this field over the past decade, patient survey data indicate that 30% of psoriasis patients do not receive adequate treatment.

Otezla is an oral selective phosphodiesterase 4 (PDE4) inhibitor originally developed by Celgene. It is currently approved in the United States for three indications: 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 adult patients with oral ulcers associated with Behçet’s disease. Since its initial approval by the U.S. FDA in 2014, Otezla has been prescribed to more than 250,000 patients with moderate-to-severe plaque psoriasis or active psoriatic arthritis. Otezla has also been approved in more than 50 countries outside the United States, including those in the European Union and Japan. Last year, Amgen acquired the development and commercialization rights to this drug from Celgene.

The ADVANCE trial is a multicenter, randomized, placebo-controlled Phase 3 clinical study designed to evaluate the efficacy and safety of Otezla in patients with mild-to-moderate plaque psoriasis. The primary endpoint was the proportion of patients achieving static Physician’s Global Assessment (sPGA) clearance at Week 16, defined as complete or almost complete clearance of skin symptoms or a reduction of at least 2 points from baseline. The trial results demonstrated that Otezla met the primary endpoint. Detailed data from this trial will be presented at future scientific conferences.

References:

[1] Amgen Announces Positive Top-Line Results From Otezla® (apremilast) Phase 3 ADVANCE Study In Mild-To-Moderate Plaque Psoriasis. Retrieved 2020-05-06, from https://www.prnewswire.com/news-releases/amgen-announces-positive-top-line-results-from-otezla-apremilast-phase-3-advance-study-in-mild-to-moderate-plaque-psoriasis-301053621.html

Original Title: Amgen's Oral Therapy Achieves Positive Top-Line Results in Treating Mild-to-Moderate Psoriasis

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