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.
The radiographic analysis set for ADEPT OLE included all patients who had a week 48 and a week 96 or week 144 assessment (n=128 for placebo; n=115 for HUMIRA).
aAll patients had a radiographic measure at baseline, week 24, week 48, and at week 96 or week 144.4bIn this analysis, data are imputed; for patients who did not have a week 144 mTSS, the week 96 mTSS was used.4
cSeparate analysis of 24-week and OLE data utilized modified patient populations and corresponding different baseline mean mTSS values.2
*Radiographic inhibition/no radiographic progression defined as change in mTSS of ≤0.5 from baseline.2
mTSS=modified total Sharp score; OLE=open-label extension; BSA=body surface area; RCT=randomized controlled trial