Long term results for Otezla in Psoriatic Arthritis- Celgene

Celgene Corporation has announced that results from long-term (104-week) efficacy and safety analyses of Otezla (apremilast) from the open-label phase of two PALACE phase III clinical trials for Psoriatic Arthritis, were presented at the 2014 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in Boston.

In PALACE 1, 84 percent (144/171) of patients who completed one year (52 weeks) of 30 mg 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 30 mg twice daily, the ACR20 response rate was 65.3 percent. ACR50 and 70 response rates were 34.0 percent and 19.6 percent, respectively, at week 104. Similar findings were observed in PALACE 4. In this trial, nearly 84 percent (168/201) of DMARD-naïve patients who completed one year of Otezla 30 mg twice daily monotherapy continued to receive Otezla at two years. At week 104, among patients treated with Otezla 30 mg twice daily monotherapy, an ACR20, 50 and 70 response was reached by 61.4 percent, 40.7 percent and 19.2 percent of patients, respectively.

In both PALACE 1 and PALACE 4, changes in other efficacy measures—including the HAQ-DI, which assesses improvements in physical function, and swollen and tender joint counts—were also generally sustained between weeks 52 and 104 with continued Otezla treatment. In PALACE 4, treatment with Otezla in patients with pre-existing enthesitis (inflammation at sites where tendons or ligaments insert into bone) or dactylitis (inflammation of an entire digit), two key manifestations of psoriatic arthritis, resulted in improvements in enthesitis and dactylitis that were sustained through 104 weeks of treatment.