(Business Wire India; 10th July, 2014); Celgene Corporation (NASDAQ:CELG) announced 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 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 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.
“ Phase III POSTURE Study Did Not Achieve Primary Endpoint of ASAS 20 at Week 16 Based on Efficacy and Safety Data at Week 24, the Independent Data Monitoring Committee Recommended Continuation of the Phase III POSTURE Study Without ChangeIn OTEZLA Study Arms, ASAS 20 Results Continued to Improve Over Time OTEZLA Tolerability and Safety Profile Consistent With Previous Clinical Trials .
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. According to the protocol, magnetic resonance imaging (MRI) data will be collected in a subgroup of subjects at week 52 and at additional time points, and radiographs will be taken on all study patients at week 104 and at additional time points.
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.
“We are encouraged by these preliminary results, especially in patients with shorter disease duration and based on our evaluation and learnings from POSTURE, we plan to initiate another Phase III trial pending further data analysis, including the 52-week MRI data,” said Scott Smith, Global Head of Inflammation & Immunology at Celgene Corporation. “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.”
The evaluation of safety and efficacy in the treatment arms is ongoing and the results of the study will be presented at an upcoming medical meeting.
These results are from an investigational phase III study. OTEZLA is not approved for the treatment of patients with ankylosing spondylitis in any country.
