Celgene announced that new findings from its ongoing Phase 3 LIBERATE trial evaluating Otezla (apremilast) in patients with moderate to severe plaque psoriasis were presented at the 24th European Academy of Dermatology and Venereology (EADV) Congress in Copenhagen, Denmark on October 7–11, 2015.
LIBERATE (PSOR-010; EvaLuatIon from a PlaceBo-controllEd Study of ORal ApremilasT and Etanercept in Plaque Psoriasis) is a Phase 3b, multicenter, randomized, placebo-controlled, double-blind, double-dummy study on the efficacy and safety of Otezla, etanercept and placebo in patients with moderate to severe plaque psoriasis. The study enrolled 250 patients with inadequate response, intolerance or contraindication to at least one conventional systemic agent and no prior biologic exposure. Patients were randomized 1:1:1 to receive Otezla 30mg twice daily, etanercept 50mg once weekly or placebo for 16 weeks. Following the first 16 weeks, all patients were switched to (or continued on) Otezla through week 104. The primary endpoint was the proportion of patients with either Otezla or placebo who achieved Psoriasis Area and Severity Index (PASI)-75 response at week 16.
Primary findings from LIBERATE were previously presented at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco. Data presented at AAD showed that 40% (33/83) of patients receiving Otezla demonstrated statistically significant and clinically meaningful improvements in PASI-75 response at week 16 compared with 12% (10/84) of patients on placebo (P<0.0001). Statistical significance was also achieved for patients receiving etanercept compared with placebo [48% (n=40/83) vs. 12% (n=10/84), respectively, P<0.0001].
New findings presented at EADV showed that 51% (42/83) of patients randomized to Otezla at baseline and 55% 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 symptom, as measured by a visual analog scale (0mm=no itch at all; 100mm=worst itch imaginable). Significantly greater improvements in itching scores were seen at week 16 for patients treated with Otezla (decrease of 38mm; 95% CI: -45 to -31mm) compared with placebo (decrease of 26mm; CI: -34 to -19mm).
Otezla is an oral, small-molecule, phosphodiesterase 4 (PDE4) inhibitor specific for cyclic adenosine monophosphate (cAMP).
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