PALACE 1 Study reported at EULAR for apremilast(Celgene) for Psoriatic Arthritis
New data presented at EULAR 2013, the Annual Congress of the European League Against Rheumatism, shows that apremilast from Celgene, administered to patients with Psoriatic Arthritis, continues to demonstrate meaningful clinical responses beyond 24 weeks. For patients who completed 52 weeks of the study, up to 65% achieved ACR20 response rates.
PALACE-1 is a phase III multi-centre, double-blind, placebo-controlled, parallel-group study with two active-treatment groups. 504 patients with active Psoriatic Arthritis, despite prior disease-modifying anti-rheumatic drugs (DMARDs) and/or biologicals over the previous 24 weeks were randomised 1:1:1 to receive either apremilast 20 mg twice daily, 30 mg twice daily or identically-appearing placebo for 24 weeks. The primary endpoint of the study was the proportion of patients in each treatment group who achieved ACR20 compared to baseline at week 16.
At week 16, significantly more apremilast 20mg (31.3%; P=0.0140) and apremilast 30mg patients (40.0%; P<0.0001) achieved an acr20 vs. placebo (19.4%). at week 52, by which time all patients had received a minimum of 28 weeks treatment with apremilast, response was generally maintained over the treatment period. at week 52, acr20 was achieved by 63.0% (apremilast 20mg) and 54.6% (apremilast 30mg) of patients.>0.0001)>
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