Celgene Announces Results From Ongoing Phase 3 LIBERATE Trial of Otezla for Psoriasis

Results from Celgene Corporation’s ongoing Phase 3 LIBERATE trial evaluating Otezla (apremilast) in patients with moderate to severe plaque psoriasis presented at 24th European Academy of Dermatology and Venereology show that half of psoriasis patients treated with oral Otezla achieved PASI 75 at week 52. 

The LIBERATE study evaluated the clinical efficacy and safety of either oral Otezla 30mg twice daily or weekly subcutaneous (SC) etanercept 50mg 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 during an open label extension phase.

At week 16, 40 percent (33/83) of patients receiving Otezla 30mg twice daily demonstrated statistically significant and clinically meaningful improvements compared with 12 percent (10/84) of patients on placebo in the primary endpoint, PASI-75 response. Statistical significance was also achieved for patients receiving weekly injections of etanercept 50 mg compared with placebo [48 percent (n=40/83) vs. 12 percent (n=10/84), respectively.

Also, 51 percent (42/83) of patients randomized to Otezla at baseline and 55 percent of patients who switched from etanercept to Otezla at week 16 (46/83) achieved PASI-75 at week 52.

Based on an exploratory analysis, Otezla also improved pruritus as measured by a visual analog scale. Significantly greater improvements in itching scores were seen at week 16 for patients treated with Otezla 30mg twice daily compared with placebo. Improvement in pruritus was observed as early as week 2 in patients receiving Otezla. Lower itching scores were also observed in patients who received weekly injections of etanercept 50mg from baseline to week 16.

Results from a Phase II head-to-head psoriasis study show superior efficacy of Boehringer Ingelheim’s investigational biologic compound BI 655066 over ustekinumab. After nine months, 69 percent of patients with moderate-to-severe plaque psoriasis maintained PASI 90 with BI 655066, compared to 30 percent of patients on ustekinumab.