In psoriatic arthritis
Significant and sustained inhibition of joint damage

ENBREL provided sustained inhibition of joint damage through 2 years1

Change in modified total Sharp Score (mTSS)*1

*mTSS = modified Total Sharp Score

  • The PsA pivotal study was a multi-center, double-blind, phase 3 study of 205 patients with active PsA1-3
  • 86% of ENBREL patients showed no radiographic progression from baseline to Year 2 (Δ in mTSS ≤0.0)1,4
Footnotes:
  • * Per protocol, in order to compare the radiographic images at Year 2 with images from baseline, 6 months, and 1 year, all images were reread. Because of the known variability in evaluation of radiographic images in psoriatic arthritis, all radiographs were reread, blinded to patient and time point, by 2 of 4 physicians. Radiographic scores were reported as an average from the 2 readers. Thus, the Year 2 scoring of the radiographic images is considered a new reading of the Year 1 time point.1,4
  • A modified Total Sharp Score (mTSS), which included distal interphalangeal joints was used. All radiographic data are based on the radiographic ITT analysis, defined as all randomly assigned patients with acceptable baseline and postbaseline radiographs. Linear extrapolation methodology was used.2,3

Study Design

THE PSORIATIC ARTHRITIS PIVOTAL STUDY1,2:

  • Multicenter, double-blind, phase 3 study of 205 patients with active PsA1,3,4
  • Mean duration of arthritic disease was about 9.1 years and mean duration of plaque psoriasis was about 19.0 years (with a qualifying target skin lesion)1,4
  • Patients were randomized to receive subcutaneous injections of ENBREL 25 mg (n=101) or placebo (n=104) administered twice weekly over the 24-week blinded treatment period1,3
  • After the 24-week period, patients continued therapy in a maintenance period of up to 6 months until all patients completed double-blind therapy. After the maintenance period, all patients received ENBREL 25 mg twice weekly in an open-label period of 48 weeks1-3
  • The data were stratified by absence or presence of concurrent MTX (either ENBREL alone [n=59] vs placebo [n=61] or ENBREL + MTX [n=42] vs placebo + MTX [n=43])1-3
  • Stable use of corticosteroids and/or NSAIDs was allowed. Of the 205 patients in the blinded study, 169 patients (81 originally receiving placebo, 88 originally receiving ENBREL) entered the open-label extension. As actual timing for radiographs may have differed from the target time points, linear extrapolation was utilized to adjust the radiographic data to the target time point1,2
  • Nonresponder imputation analysis was conducted during the double-blind portion for ACR response and skin lesion clearing, while parameters assessed during the open-label period were analyzed based on the observed population at each time point1
  • In the double-blind portion of the study, pain, morning stiffness, CRP, HAQ, and skin assessments were evaluated at Weeks 0, 4, 12, and 24. In the open-label extension, these endpoints were evaluated at Weeks 0, 4, 12, 24, 36, and 483,5
  • The primary efficacy endpoint was ACR 20 at 12 weeks1
  • The primary radiographic endpoint was the annualized rate of change in TSS over 1 year of treatment1
  • Secondary radiographic endpoints included annualized rate of change in TSS, erosion score, and joint space narrowing score at 6, 12, and 24 months1
  • Radiographs of hands and wrists were taken at baseline and 6 months in the controlled portion of the study, at initiation of open-label treatment, at 1 year and 2 years from original baseline, and at early termination from the study during either part of the study1,2
  • All patients who received at least 1 dose of study drug and who had at least 1 radiograph were to be included in the radiographic analysis. Scores were adjusted to a 6- or 12-month basis using linear interpolation/extrapolation of the observed change1,2,6
  • The mean duration of ENBREL exposure during the 12-month radiographic period was 331.6 days in the ENBREL group and 27.6 days in the placebo group6

TSS is based on combined scores of joint erosions in the hands and wrists on a scale of 0 to 5 (0=no damage) and joint space narrowing in the hands and wrists on a scale of 0 to 4 (0=no narrowing) and was modified to include an assessment of the distal interphalangeal joints. Data are shown for all patients having a 2-year radiograph (n=141).1,2,7

 
Supportive data
Moderate to Severe Rheumatoid Arthritis

In medical studies, ENBREL was shown to be clinically effective in about 2 out of 3 adults with moderate to severe RA at 3 months. ENBREL has been shown to begin working in as few as 2 weeks, and most patients who benefit will do so within 3 months. In another medical study, 55% of patients who were evaluated 5 years after beginning ENBREL therapy had no further progression of joint damage.

Psoriatic Arthritis

In a medical study, ENBREL was shown to be effective in about 50% of psoriatic arthritis patients at 6 months. Clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.

Important Safety Considerations

In psoriatic arthritis

ENBREL improved skin symptoms

View data
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Phil Mickelson: A PsA Patient's Perspective

Listen to Phil share his personal experience to gain more insight about your patients.

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Phil Mickelson: A PsA patient's perspective
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Treating Moderately Active RA
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Rapid, Sustained Efficacy of ENBREL
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Improving Outcomes in Psoriatic Arthritis
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A look back at 15 years