Otezla significantly improved measures of disease severity in adults with mild-to-moderate plaque psoriasis – Amgen

Amgen 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 , according to findings from the placebo-controlled, Phase III ADVANCE trial. Results were presented at the American Academy of Dermatology Virtual Meeting Experience 2021.

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 less than 5% treated with Otezla compared to placebo achieved a BSA less than 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 greater than 5% in ADVANCE. At week 16, a greater proportion of adults with BSA greater than 5% treated with Otezla compared to placebo achieved a BSA less than 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%).

In February 2021, Amgen submitted a supplemental New Drug Application to the FDA for Otezla for the treatment of adults with mild-to-moderate plaque psoriasis based on the Phase III ADVANCE data.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 t 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.