Apremilast, Experimental Psoriatic Arthritis Drug, Shows Promising Results in Phase 3 Trial
On July 12, Celgene Corporation reported results from the PALACE-1 study, the first of three pivotal phase III trials evaluating apremilast, the company’s experimental phosphodiesterase 4 (PDE4) inhibitor, in patients with psoriatic arthritis.
Approximately 500 patients were randomly assigned to receive apremilast 20 mg twice daily, apremilast 30 mg twice daily, or placebo for 24 weeks. All of the patients had received an oral disease-modifying antirheumatic drug (DMARD) or biologic therapy or had failed on an anti-tumor necrosis factor (TNF) agent before entry into the study.
The study’s primary endpoint was the proportion of patients in each treatment group who achieved the American College of Rheumatology criteria for 20% improvement (ACR20) compared with baseline at week 16. Secondary endpoints included other measures of signs and symptoms, physical function, and patient-reported outcomes.
Statistical significance for the primary end point of ACR20 was achieved for patients receiving apremilast. Patients in the active treatment arms also maintained significant improvements in arthritis-related endpoints, including ACR50 and ACR70, through week 24. Significant and sustained improvements in various measures of physical function were also observed in apremilast-treated patients.
The PALACE-1 study is ongoing. An extension phase, in which all patients receive apremilast, remains blinded until the patients complete week 52. Results from the other phase III studies of apremilast in psoriatic arthritis (PALACE 2 and PALACE 3) are expected in the third quarter of 2012. The NDA submission, based on the combined PALACE program, is scheduled for the first half of 2013.
Apremilast, an oral small-molecule PDE4 inhibitor, works intracellularly to modulate pro-inflammatory and anti-inflammatory mediators.
For more information, visit the Reuters article.