Amgen’s Otezla (apremilast) improved measures of disease severity in adults with mild-to-moderate plaque psoriasis regardless of their Body Surface Area (BSA) involvement, according to findings from the placebo-controlled, phase 3 ADVANCE trial, presented at the AAD VMX 2021.

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

"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," says Linda Stein Gold, MD, 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."

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%, at least a 75% improvement in BSA, and a Scalp PGA (ScPGA) response score of clear or almost clear. Comparable improvements in disease severity were seen in adults with BSA >5% in ADVANCE.

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, headache, nausea, upper respiratory tract infection, and nasopharyngitis.

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 3 ADVANCE data. 

"These positive ADVANCE results add to the growing evidence supporting the potential benefit of Otezla in adults with mild-to-moderate plaque psoriasis," says 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."