Apremilast: Additional Phase III data

Additional data from the double-blind, international Phase III PALACE-3 trial in about 500 patients showed that twice-daily 20 and 30 mg oral apremilast led to ACR20 response rates, the primary endpoint, of 29% and 43%, respectively, at week 16 vs. 19% for placebo (p=0.02 and p<0.0001). Additionally, ACR20 response rates at week 24 were 40% for low-dose apremilast and 42% for high-dose apremilast. In patients who were naïve to treatment with biologics, low- and high-dose apremilast led to ACR20 response rates at week 16 of 33% and 44%, respectively, vs. 21% for placebo (p<0.05 for both). Furthermore, Psoriasis Area Severity Index (PASI) 50 response rates at week 24 were 36% for low-dose apremilast and 46% for high-dose apremilast compared to 26% for placebo (p<0.05 for high-dose apremilast vs. placebo). PASI 75 response rates at week 24 were 23% for low-dose apremilast and 27% for high-dose apremilast compared to 12% for placebo (p<0.05 for high-dose apremilast vs. placebo). The trial enrolled patients with active psoriatic arthritis who had failed oral DMARDs, and/or an anti- tumor necrosis factor (TNF) agent. Data were presented at the European League Against Rheumatism meeting in Madrid. ...