Celgene's Otezla Does Not Achieve Primary Phase III Endpoint

July 9, 2014 1:41 PM

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Celgene's Otezla Does Not Achieve Primary Phase III Endpoint

Celgene reported results of its Phase III POSTURE study evaluating Otezla, the company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with active ankylosing spondylitis. The Otezla arms did not achieve statistically significant improvement versus placebo for the primary endpoint, the percentage of patients who achieve an ASAS (Assessment of SpondyloArthritis international Society) 20 response at week 16. However, in a prespecified analysis, meaningful efficacy was observed at week 24 in a large subset of patients with early-stage disease. Evaluation of the efficacy results is ongoing.

An independent data monitoring committee recommended that the study proceed unchanged, based on an assessment of the safety and efficacy data at week 24. According to the protocol, magnetic resonance imaging (MRI) data will be collected in a subgroup of subjects at week 52 and at additional time poi...

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