For adult patients with active psoriatic arthritis (PsA)

Alleviates signs and symptoms

Improvement of signs and symptoms in many HUMIRA-treated patients vs placebo


STUDY DESIGN INTRODUCTION

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

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ACR response

Almost 6 out of 10 HUMIRA-treated patients experienced ACR 20 response after both 12 and 24 weeks1,4

percentage of HUMIRA-treated and placebo-treated patients who experienced ACR 20, ACR 50, and ACR 70 response after 12 and 24 weeks

HUMIRA 40 mg EOW (n=151)

ACR 20

ACR 50

ACR 70

Placebo EOW (n=162)

ACR 20

ACR 50

ACR 70

aP<0.001

ACR Components

The above analysis is of the intent-to-treat population, using nonresponder imputation (NRI) methodology. Patients who withdrew, had missing data, or received rescue therapy were counted as non-responders.
ACR 20: ≥ 20% improvement in both tender and swollen joint counts, plus ≥ 20% improvement in at least 3 out of the following3:

  • Patient's assessment of pain
  • Patient global assessment of disease activity
  • Physician global assessment of disease activity
  • Disability index of the HAQ
  • Acute-phase reactants, such as erythrocyte sedimentation rate and C-reactive protein (CRP)

*mTSS measures erosions and joint space narrowing, as well as radiographic changes specific to PsA patients, including DIP joints, with a maximum score of 570.3,5
ACR 50 and ACR 70 analyses include the same criteria as ACR 20 with the use of a higher percentage improvement (50% and 70%, respectively).4
ACR=American College of Rheumatology

Open-label extension

ACR response rates at 48 and 104 weeks4

OLE ACR 20, ACR 50, and ACR 70 responses at weeks 48 and 104

HUMIRA 40 mg EOW (n=281)

ACR 20

ACR 50

ACR 70

ACR Components

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.


aLOCF analysis based on the duration of exposure to HUMIRA (including those patients originally randomly assigned to placebo).
*mTSS measures erosions and joint space narrowing, as well as radiographic changes specific to PsA patients, including DIP joints, with a maximum score of 570.2,5

ACR=American College of Rheumatology; EOW=every other week; LOCF=last observation carried forward; OLE=open-label extension