Long-term apremilast demonstrates continued efficacy in patients with psoriatic arthritis

Novel PDE-4 inhibitor continues to be well tolerated with an acceptable long-term safety profile

2013-06-12

(Press-News.org) Madrid, Spain, 12 June 2013: New data presented today at EULAR 2013, the Annual Congress of the European League Against Rheumatism show that apremilast 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. Also, apremilast continued to be well tolerated with an acceptable longer-term safety profile.

Apremilast is a novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4). It works as an anti-inflammatory drug by modulating a network of pro- and anti-inflammatory mediators inside cells.

PsA is a chronic inflammatory arthritis associated with psoriasis which significantly impacts health-related quality of life in patients, and increases risk of co-morbid cardiovascular and gastrointestinal disease.2 Psoriasis occurs in 2-3% of the population, with PsA occurring in up to 30% of those of cases.3

"Over the course of their disease patients with psoriatic arthritis may take a variety of treatment regimens over extended periods of time. Durability of response is therefore important. This relatively large study suggests that apremilast has sustained efficacy and tolerability over a year among patients previously treated with DMARDs and/or biologic agents" said Dr Arthur Kavanaugh, Professor of Medicine at the University of California, San Diego. "These results show that apremilast may become a potential therapy for psoriatic arthritis patients," he added.

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. Secondary endpoints included other measures of symptoms and signs, physical function and patient-reported outcomes.

At week 16, significantly more apremilast 20mg (31.3%; P=0.0140) and apremilast 30mg patients (40.0%; P END

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