IntroductionLIBERATE (NCT01690299), a global phase 3b study in biologic‐naive patients with moderate to severe plaque psoriasis, demonstrated that significantly more patients receiving apremilast for 16 weeks achieved PASI‐75 (≥75% reduction from baseline in Psoriasis Area and Severity Index [PASI]) vs. placebo. A post hoc analysis found no significant difference in response rates among patients given apremilast vs. etanercept, an anti‐tumour necrosis factor‐α biologic agent.This report describes efficacy and safety outcomes from the LIBERATE apremilast‐extension phase (Weeks 16–104) in patients who continued apremilast treatment through 104 weeks, including those who switched from etanercept or placebo.Materials and methodsPatients and study designPatient selection, study design and study methods have been described in detail. Briefly, patients in the LIBERATE trial were adults in the United States, Canada, Europe (Belgium, Czech Republic, Estonia, Germany, Great Britain, Hungary, Latvia, the Netherlands) or Australia with chronic, moderate to severe plaque psoriasis with inadequate response, inability to tolerate or contraindication to treatment with ≥1 conventional systemic agent, and who were biologic‐naive. Eligible patients were randomized (1 : 1 : 1) to double‐blind treatment with apremilast 30 mg twice daily, etanercept subcutaneous injection 50 mg once weekly, or placebo for 16 weeks. At Week 16, placebo and etanercept
Journal of the European Academy of Dermatology & Venereology – Wiley
Published: Jan 1, 2018
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