Phase IV UNVEIL trial of Otezla (apremilast) shows benefits in moderate plaque psoriasis- Celgene

Celgene announced that results from its phase IV UNVEIL trial evaluating Otezla (apremilast), in patients with moderate plaque psoriasis with a body surface area (BSA) of 5-10 percent. The UNVEIL study evaluated the clinical efficacy and safety of oral Otezla 30 mg twice daily compared with placebo at week 16 in 221 patients with moderate plaque psoriasis [defined as a BSA involvement of 5-10 percent and a static Physician's Global Assessment (sPGA) of 3] who were naïve to systemic and biologic therapy. At baseline, more than 80 percent of patients enrolled in the trial had previously received topical therapy. The primary endpoint was the mean percentage change from baseline in the product of PGA and BSA (PGA×BSA) at week 16. The PGAxBSA composite tool is a simple assessment that has been developed as a measure of clinically meaningful responses of psoriasis patients in clinical trials.

At week 16, patients who received Otezla had a significantly greater improvement in mean percentage change from baseline in PGA×BSA compared with those who received placebo (-48.1 vs. -10.2, respectively). In addition, a 75 percent or greater improvement in PGA×BSA score was achieved by 35.1 percent of patients treated with Otezla vs. 12.3 percent of patients treated with placebo). A significantly greater percentage of patients receiving Otezla versus placebo achieved a PGA score of 0 (clear) or 1 (almost clear) at week 16 (30.4 percent vs. 9.6 percent). In other secondary endpoints, enrolled patients who had scalp psoriasis (n=167), a significantly greater percentage who received Otezla achieved a Scalp Physician’s Global Assessment score of 0 (clear) or 1 (minimal) with a greater than two-point reduction from baseline compared with placebo (38.0 percent vs. 20.0 percent, respectively). Data were presented at the American Academy of Dermatology's Annual Meeting.