For adult patients with active psoriatic arthritis (PsA)
ADEPT was a 24-week randomized, double-blind, placebo-controlled study in 313 adult patients with active PsA who had inadequate response to NSAIDs. Co-primary endpoints were ACR 20 response at week 12 and mean change from baseline in mTSS for HUMIRA-treated patients at week 48 vs placebo at week 24. Patients who completed the original 24-week double-blind ADEPT study (n=285) were eligible for open-label treatment through week 144.1-4
OLE limitations: As with any long-term open-label extension, there are several limitations with the OLE portion of this study. For example, there is the potential for enrichment of the long-term data in the remaining patient population, as those who remain in the study generally fare better than those who discontinue.