THU0439 52-Week Efficacy and Safety of Apremilast and Switch from Etanercept in Patients with Moderate To Severe Psoriasis: Results from The Liberate Study

BackgroundPsoriasis is a chronic systemic inflammatory disease often treated with conventional systemic and biologic drugs that may variously be ineffective, inaccessible, or pose significant safety and tolerability risks.ObjectivesThe phase IIIb LIBERATE (Evaluation in a Placebo-Controlled Study of Oral Apremilast and Etanercept in Plaque Psoriasis) study (NCT01690299) evaluated the efficacy and safety of apremilast or etanercept vs. placebo in biologic-naive patients (pts) with moderate to severe plaque psoriasis.MethodsIn this double-blind, double-dummy study, pts were randomized (1:1:1) to placebo (PBO), apremilast 30 mg BID (APR), or etanercept 50 mg QW (ETN) through Wk16; thereafter, all pts switched to or continued APR (PBO/APR, ETN/APR, APR/APR). The primary endpoint was achievement of a ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score (PASI-75) at Wk16 with APR vs. PBO; secondary endpoint was PASI-75 achievement at Wk16 with ETN vs. PBO. Additional physician global assessments (PGA) of disease activity were conducted using the static (sPGA), lattice system (LS-PGA), and scalp (ScPGA) instruments; nail disease was also evaluated (Nail Psoriasis Severity Index [NAPSI]). Responses were assessed at Wks16 and 52 using the last-observation-carried-forward (LOCF) methodology.Results250 pts received ≥1 dose of study drug, had both baseline PASI and ≥1 post-treatment PASI evaluations, and were included in the analysis set (PBO n=84; APR n=83; ETN n=83). At baseline, 166 (66.4%; PBO n=58; APR n=54; ETN n=54) pts had an ScPGA score ≥3 (moderate to very severe) and 148 (59.2%; PBO n=46; APR n=52; ETN n=50) had a NAPSI score ≥1. At Wk16, PASI-75 achievement was significantly greater (P