US-based biotechnology firm Celgene has reported results from its Phase III POSTURE trial evaluating its oral, selective inhibitor of phosphodiesterase 4 (PDE4) ‘Otezla’, in patients with active ankylosing spondylitis.
Patients treated in the Otezla arms did not achieve significant improvement versus the placebo arm for the primary endpoint, which is the percentage of people who achieve an ASAS (Assessment of SpondyloArthritis international Society) 20 response at week 16.
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At Week 24, the prespecified analysis showed that meaningful efficacy was seen in a large subset of patients with early-stage disease.
Based on an evaluation of the safety and efficacy data at week 24, an independent data monitoring committee (DMC) suggested that the study proceed unchanged.
Safety and tolerability data observed in the POSTURE trial are consistent with previously reported Phase II data in ankylosing spondylitis, as well as six Phase III trials of Otezla in psoriatic arthritis or psoriasis.
Celgene global head of Inflammation & Immunology Scott Smith said: "Ankylosing spondylitis is a chronic, debilitating disease, and despite advances over the last 15 years, there remains significant unmet need for a safe, effective, oral therapy, especially for patients early in the progression of their disease."
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By GlobalDataThe assessment of safety and efficacy in the treatment arms is ongoing and the results of the trial will be presented at an upcoming medical meeting.
The company said that Otezla is not approved for the treatment of patients with ankylosing spondylitis in any country.
On the Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group POSTURE trial, 490 subjects were randomised in a 1:1:1 ratio to receive either apremilast 20mg BID, apremilast 30mg BID, or identically-appearing placebo for 24 weeks, with a subsequent long-term extension phase in which all subjects are treated with apremilast.
