Otezla phase 3 advance trial results

[Fred]

Amgen today announced Otezla (apremilast) improved measures of disease severity in adults with mild-to-moderate plaque psoriasis regardless of their Body Surface Area (BSA) affected by the disease.

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"Many people with mild-to-moderate plaque psoriasis still report challenges in managing their symptoms, which can have a significant impact on their daily lives, despite the availability of existing topical treatment options," said Linda Stein Gold, M.D., director of dermatology clinical research at Henry Ford Health System, Detroit, and lead investigator for the ADVANCE study. "The ADVANCE findings demonstrated that oral apremilast significantly improved clinical measures of disease severity, such as Body Surface Area and scalp involvement."

In ADVANCE, oral Otezla 30 mg twice daily achieved a statistically significant improvement of the primary endpoint of static Physician's Global Assessment (sPGA) response at week 16 compared to placebo (21.6% vs. 4.1%, p<0.0001). These clinical improvements were maintained through week 32.

Otezla also demonstrated improvements in all secondary endpoints at week 16. A greater proportion of adults with BSA ≤5% treated with Otezla compared to placebo achieved a BSA ≤3% (respectively 71.7% vs. 35.8%), at least a 75% improvement in BSA (29.0% vs. 6.1%) and a Scalp PGA (ScPGA) response score of clear or almost clear (35.6% vs. 12.9%).

Comparable improvements in disease severity were seen in adults with BSA >5% in ADVANCE. At week 16, a greater proportion of adults with BSA >5% treated with Otezla compared to placebo achieved a BSA ≤3% (respectively 54.6% vs. 14.9%), at least a 75% improvement in BSA (36.8% vs. 8.6%), and a ScPGA response score of clear or almost clear (50.6% vs. 19.2%).

The adverse events observed in this trial analysis were consistent with the known safety profile of Otezla. The most commonly reported (≥5%) treatment-emergent adverse events with Otezla treatment were diarrhea (14.3%), headache (12.9%), nausea (12.7%), upper respiratory tract infection (8.5%) and nasopharyngitis (6.8%).

"These positive ADVANCE results add to the growing evidence supporting the potential benefit of Otezla in adults with mild-to-moderate plaque psoriasis," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to continuing to work with the FDA to potentially expand access to oral Otezla to adults with mild-to-moderate disease severity."

In the U.S., Otezla is 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 for adult patients with oral ulcers associated with Behçet's Disease. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 250,000 patients with moderate-to-severe plaque psoriasis or active psoriatic arthritis in the U.S.

Source: amgen.com

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