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Investigative Apremilast Shows Efficacy and Safety for Treatment of Plaque Psoriasis: Presented at AAD

By Bruce Sylvester

SAN ANTONIO, TX -- February 4, 2008 -- The Investigative oral therapy apremilast (CC-10004) is both effective and safe for treatment of moderate to severe plaque-type psoriasis, researchers reported here at the American Academy of Dermatology 66th Annual Meeting (AAD).

"We continue to see a need for new treatments for patients who fail to respond to current therapies," said presenter and lead investigator Kim Papp, MD, PhD, Associate Clinical Professor of Medicine, University of Western Ontario Medical School, London, Ontario, Canada.

Dr. Papp said that his team observed a statistically significant response, according to the Psoriasis Area Severity Index (PASI 75) score, with a trend for significance on the PASI 90 on 20 mg twice daily dosing. "We saw no significant adverse events," he said during his presentation on February 2.

In this phase 2 study, investigators randomised 260 subjects to apremilast 20 mg twice daily, apremilast 20 mg once daily, or placebo for 12 weeks.

The primary endpoint was the proportion of subjects treated with apremilast who had achieved a PASI 75 response at week 12 (last treatment relative to the baseline visit). "Last treatment" was the last PASI assessment completed during the 12-week treatment phase.

At week 12, a statistically significantly higher proportion of subjects treated with 20 mg twice daily achieved PASI 75 response compared with the placebo group (24% vs 10%; P =.023).

Among subjects receiving 20 mg twice daily or placebo, 57% versus 23%, respectively, achieved PASI 50 at week 12 from last treatment. Among the 20 mg twice daily apremilast group versus 6% of the placebo group achieved PASI 90.

Adverse event profiles were similar for apremilast and placebo. No serious adverse events related to the study drug were reported in this study.

Funding for the study was provided by Celegene Corporation.


[Presentation title: A Phase 2 Study Demonstrating the Efficacy and Safety of the Oral Therapy CC-10004 in Subjects With Moderate to Severe Psoriasis. Abstract P2614]

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