Otezla results in Phase III POSTURE study for Ankylosing Spondylitis- Celgene

Celgene Corporation announced results of its phase III POSTURE study evaluating Otezla (apremilast), 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 the placebo arm 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 pre-specified 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 (DMC) recommended that the study proceed unchanged, based on an assessment of the safety and efficacy data at week 24. The safety and tolerability data observed in the POSTURE study are consistent with previously reported phase II data in Ankylosing Spondylitis, as well as six phase III studies of Otezla in psoriatic arthritis or psoriasis. No new safety signals were observed.