Celgene announced results from two PALACE Phase 3 clinical trials with Otezla (apremilast) for the treatment of adults with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
PALACE 1 and 4 are multi-center, double-blind, placebo-controlled, parallel-group studies with two active-treatment groups. In PALACE 1, 2 and 3, approximately 1,500 patients were randomized 1:1:1 to receive either Otezla 20mg or 30mg twice daily or placebo for 16 weeks. At week 16, some placebo-treated patients were randomized to one of the two Otezla groups, while others remained on placebo through week 24. After week 24, patients began a subsequent long term, open-label, active treatment phase. In PALACE 4, more than 500 DMARD-naïve patients were randomized 1:1:1 to receive either Otezla 20mg or 30mg twice daily, or placebo, for 24 weeks, with a subsequent active treatment phase up to 52 weeks, followed by a long-term safety phase in which all patients are treated with Otezla. The primary endpoint of the PALACE 1, 2, 3 and 4 studies was the modified American College of Rheumatology criteria for 20% improvement (ACR20) at week 16.
In PALACE 1, 84% (144/171) of patients who completed one year (52 weeks) of 30mg twice daily therapy continued to receive Otezla at two years (104 weeks). Improvements in efficacy measures observed at 52 weeks were sustained through 104 weeks of treatment. At week 104, among patients receiving Otezla 30mg twice daily, the ACR20 response rate was 65.3%. ACR50 and 70 response rates were 34% and 19.6%, respectively, at week 104. In PALACE 4. In this trial, nearly 84% (168/201) of DMARD-naïve patients who completed one year of Otezla 30mg twice daily monotherapy continued to receive Otezla at two years. At week 104, among patients treated with Otezla 30mg twice daily monotherapy, an ACR20, 50 and 70 response was reached by 61.4%, 40.7%, and 19.2% of patients, respectively.
Otezla is already indicated for active psoriatic arthritis and for moderate-to-severe plaque psoriasis in adults who are candidates for phototherapy of systemic therapy. Otezla is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients with psoriasis or psoriatic arthritis is not well defined.
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