- Clinically Meaningful Improvements in Physician-Reported Outcomes Maintained Through Week 32
- Consistent Efficacy Was Observed at Week 16 in Subgroups of Patients with BSA <5% and BSA >5% in the Phase 3 ADVANCE Trial
- Supplemental New Drug Application for Otezla to Treat Adults with Mild-to-Moderate Plaque Psoriasis Currently Under Review by the U.S. Food and Drug Administration
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 3 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 ≤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%).
In February 2021, Amgen submitted a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Otezla for the treatment of adults with mild-to-moderate plaque psoriasis based on the Phase 3 ADVANCE data.