Oral Apremilast Shows Positive Long-Term Data in Psoriatic Arthritis

Celgene announced positive 52-week results for oral apremilast from the company's study PALACE 1, a Phase 3 study that evaluated patients with psoriatic arthritis.

PALACE 1 is the first of four (PALACE 2, 3, 4) completed randomized, multicenter, double-blind, placebo-controlled studies evaluating patients with psoriatic arthritis who have received oral disease-modifying antirheumatic drugs (DMARD) and/or biologic therapy and/or have failed on an anti-tumor necrosis factor (TNF) agent. In PALACE 1, 2 and 3, approximately 1,500 subjects were randomized to either apremilast 20mg twice daily, apremilast 30mg twice daily, or placebo for 24 weeks, with a subsequent extension in which all patients were treated with apremilast.

The primary endpoint of the PALACE 1, 2 & 3 studies is the proportion of patients in each treatment group who achieved the ACR20 compared to baseline at Week 16.

Long-term results from PALACE 1 demonstrated meaningful improvement in American College of Rheumatology (ACR) 20 scores from Week 24–52. Patients in the apremilast treatment arm for 52 weeks demonstrated ACR scores of 63% for apremilast 20mg twice daily and 55% for apremilast 30mg twice daily. Similar improvement data were observed in the ACR 50 and ACR 70 scores.

Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) that intracellularly modulates a network of pro-inflammatory and anti-inflammatory mediators.

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