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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

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.

"There remains significant unmet need for a safe, effective, oral therapy, especially for patients early in the progression of their disease."

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."

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The 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.