For adult patients with active psoriatic arthritis (PsA)

Inhibits progression of structural damage

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Less joint damage progression in many HUMIRA-treated patients vs placebo in the ADEPT clinical trial1-3


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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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Radiographic progression

Mean change in the modified total Sharp score (mTSS) at baseline, week 24, and week 48

Mean change in the modified total Sharp score (mTSS) at baseline, week 24, and week 48

*Radiographic inhibition/no radiographic progression defined as change in mTSS of ≤0.5 from baseline.2
HUMIRA patients with no radiographic progression in the OLE were treated with HUMIRA EOW in the RCT.2
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
§For HUMIRA-treated patients who did not have an mTSS at week 48, mTSS was imputed by linear extrapolation using the baseline and week 24 scores. The mTSS was used by the reader blinded to treatment group to assess the radiographs.2

Example Radiograph of a Severe PsA Patient

example radiograph of a severe PsA patient

An example of a radiograph from a patient with PsA. Not all PsA patients’ disease will get this severe. For illustrative purposes only.

Radiograph of a 58-year-old woman with psoriatic arthritis. Source: Science Source.


ACR=American College of Rheumatology; mTSS=modified total Sharp score; OLE=open-label extension; RCT=randomized controlled trial

Radiographic inhibition* at 24 and 48 weeks1,3

Week 24

91%

of HUMIRA-treated patients (n=144)
had no radiographic progression*


vs


71%

of placebo-treated patients (n=152)

Week 48

87%

of HUMIRA-treated patients (n=133)
had no radiographic progression*†

Nearly 9 out of 10 HUMIRA patients had no radiographic progression* after 48 weeks

OLE Limitations

As with any long-term OLE, 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


Open-label extension

Radiographic response through 144 weeks of OLE4

radiographic response through 144 weeks of OLE

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 144.4
bIn 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