LIBERATE study results of Otezla (apremilast) in Plaque Psoriasis- Celgene

Celgene Corporation announced that results from its ongoing phase III LIBERATE trial evaluating Otezla (apremilast), in patients with moderate to severe plaque psoriasis were presented at a late-breaker presentation at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco, California .

The LIBERATE study evaluated the clinical efficacy and safety of either oral Otezla 30 mg twice daily or weekly subcutaneous (SC) etanercept 50 mg compared with placebo at week 16 in 250 patients who had no prior exposure to a biological therapy. It also examined the relative safety of a switch from etanercept to Otezla after week 16. At week 16, patients receiving Otezla 30 mg twice daily demonstrated statistically significant and clinically meaningful improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI)-75 response [primary endpoint; 40 percent with Otezla (n=33/83), 12 percent with placebo (n=10/84), P < 0.0001]. At week 16, statistical significance was also achieved for patients receiving weekly injections of etanercept 50 mg when compared with placebo [48 percent with etanercept (n=40/83), 12 percent with placebo (n=10/84), P < 0.0001]. A post-hoc analysis revealed no significant difference between Otezla and etanercept (P=0.2565) in PASI -75 at week 16. LIBERATE was not designed or powered to directly compare Otezla to etanercept.