Apremilast: Phase III data
Top-line data from the double-blind, international Phase III PALACE-1 trial in about 500 patients showed that twice-daily 20 and 30 mg oral apremilast each met the primary endpoint of improving the proportion of patients achieving an ACR20 response at week 16 vs. placebo. High-dose apremilast also met the secondary endpoints of improving ACR50 and ACR70 response rates at week 24 vs. placebo. Low-dose apremilast met the ACR50 endpoint, but missed the ACR70 endpoint.
Celgene also said apremilast produced significant and sustained improvements in other arthritis-related endpoints and in various measures of physical function, but did not disclose details. The company also said that gastrointestinal adverse events, upper respiratory tract infections and headache were no more common in patients receiving apremilast compared to placebo. The trial enrolled patients with active psoriatic arthritis who had received an oral DMARD, biologic therapy or had failed on an anti- tumor necrosis factor (TNF) agent. ...