Celgene announces phase 3 results for Otezla

The oral phosphodiesterase 4 selective inhibitor, Otezla, did not meet the primary endpoint of the POSTURE study but did achieve meaningful efficacy by week 24, according to a company press release.

Otezla (apremilast, Celgene) was approved by the U.S. Food and Drug Administration in March for the treatment of active psoriatic arthritis in adults, but is not yet approved for treating active ankylosing spondylitis.

The phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group POSTURE study aimed to evaluate the drug’s safety and efficacy in the treatment of active ankylosing spondylitis. Researchers enrolled 490 patients and randomly assigned them to receive apremilast 20 mg, apremilast 30 mg or placebo twice per day for 24 weeks. The study also included a subsequent long-term extension phase in which all patients were treated with apremilast.

POSTURE’s primary endpoint was the proportion of patients who achieved an Assessment of SpondyloArthritis international Society 20 response, or an improvement of at least 20%, by week 16. Although patients did not reach statistically significant improvement compared with placebo by week 16, apremilast achieved meaningful efficacy at week 24 among patients within the early stages of disease, according to the release.

The study is ongoing, with MRI data to be collected from a subgroup of patients at week 52 and additional time points, and radiographs to be collected from all patients at week 104 and additional time points.

Celgene plans to present results from the study at an upcoming medical conference, according to the release.