Celgene’s Otezla successful in late-stage study in expanded psoriasis population – Seeking Alpha

Results from a Phase 4 clinical trial, UNVEIL. evaluating Celgene's (CELG -0.6%) Otezla (apremilast) in patients with moderate plaque psoriasis with a body surface area of 5 - 10% showed a significant treatment benefit compared to placebo. The results were presented at the American Academy of Dermatology's Annual Meeting in Orlando, FL.

UNVEIL evaluated oral OTEZLA (30 mg twice daily) compared to placebo at week 16 in 221 subjects with moderate plaque psoriasis who had not been treated with systemic or biologic therapy. At baseline, 80% (n=177) had received topical therapy. The primary endpoint was the mean percent change from baseline in the product of PGA and BSA scores (two measures of psoriasis severity) at week 16.

The mean changes for the Otezla and placebo cohorts were -48.1% and -10.2%, respectively (p<0.0001). The proportions of patients who achieved at least a 75% improvement in symptoms were 35.1% and 12.3%, respectively (p<0.0001). The proportions of patients who achieved clear or almost clear skin were 30.4% and 9.6%, respectively (p<0.0001).

The most common treatment-relate adverse events were diarrhea (29%), headache (20%), nausea (18%), upper respiratory tract infection (7%) and vomiting (6%).

Otezla is currently approved to treat moderate-to-severe plaque psoriasis.

View original post here:
Celgene's Otezla successful in late-stage study in expanded psoriasis population - Seeking Alpha