ENBREL can provide sustained inhibition of structural damage and significant improvement in skin symptoms of PsA

In the Psoriatic Arthritis pivotal trial, ENBREL patients sustained inhibition of structural damage through 2 years1-4*†

  • 86% of patients on ENBREL showed no radiographic progression from baseline to 2 years (Δ mTSS ≤0.0)3,4
  • Most patients showed little or no change in the mTSS during this 24-month study (median change of 0 in both groups)1,3,4

Change in modified Total Sharp Scores (mTSS)1,3*†

Efficacy in psoriatic arthritis

 *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 two of four physicians. Radiographic scores were reported as an average from the two readers. Thus, the Year 2 scoring of the radiographic images is considered a new reading of the Year 1 time point.
 †mTSS is calculated using the Sharp/van der Heijde method. 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.

One-year data
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At year 1 in the Psoriatic Arthritis pivotal trial, ENBREL significantly inhibited radiographic progression vs. placebo (Δ mTSS = -0.03 vs 1.00, P = 0.0001) (This was a primary endpoint.)1,3

  • More placebo-treated patients had larger magnitudes of radiographic worsening (increased TSS) compared with ENBREL treatment during the controlled period of the study3
  • At 12 months, in an exploratory analysis, 12 of 104 placebo patients compared with 0 of 101 patients treated with ENBREL had increases of ≥ 3 units in TSS3
Study Descriptions
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The Psoriatic Arthritis Pivotal Trial1-4:

  • Multicenter, double-blind, phase 3 trial of 205 patients with active psoriatic arthritis
  • 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)
  • 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 period
  • After the 24-week period, patients continued therapy in a maintenance period 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 weeks
  • 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])
  • 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 for the radiographic data to the target time point
  • 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 point
  • The primary radiographic endpoint was the annualized rate of change in TSS over 1 year of treatment
  • Secondary radiographic endpoints included annualized rate of change in TSS, erosion score, and joint space narrowing score at 6, 12, and 24 months
  • Radiographs of hands and wrists were taken at baseline and 6 months in the controlled portion of the trial, 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 study
  • 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 6- or 12-month basis using linear interpolation/extrapolation of the observed change
  • 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 group

Definition:

  • 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)

References

  1. Enbrel® (etanercept) Prescribing Information. Thousand Oaks, CA: Immunex Corporation; February 2011.
  2. Data on file, Amgen.
  3. Mease PJ, Kivitz AJ, Burch FX, et al. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum. 2004;50:2264-2272.
  4. Mease PJ, Kivitz AJ, Burch FX, et al. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol. 2006;33:712-721.
View Study Designs and Descriptions

Patients on ENBREL experienced substantial skin clearing1,2

The PRESTA study was a 24-week, randomized, multicenter, two-period study of 752 patients with active psoriatic arthritis, consisting of a 12-week double-blind treatment period followed by a 12-week open-label treatment period. In the PRESTA study, patients on ENBREL 50 mg QW achieved substantial improvement in skin symptoms as measured by PASI 75ठand BSA|| (LOCF)1

  • In the Psoriatic Arthritis pivotal trial, 23% of patients on ENBREL 25 mg BIW (n = 14/60), compared with 3% of patients on placebo (n = 1/38), achieved PASI 75 at 24 weeks (P = 0.001)2§

§Only patients with at least 3% of BSA at baseline were evaluated for PASI responses

In the PRESTA Study, improvement in skin symptoms as measured by PASI 75ठand BSA|| involvement for patients on ENBREL 50 mg QW (LOCF)1

Efficacy in psoriatic arthritis
  • 32% of patients on ENBREL 50 mg QW achieved the primary endpoint of clear/almost clear PGA (Physician Global Assessment) scores at 12 weeks.1
  • At baseline, the mean BSA of patients in the PRESTA study was 30%; it was 11% in the Psoriatic Arthritis pivotal trial.1,2
  • 15% more patients who received ENBREL 50 mg QW (n = 360) achieved ACR 70 response at 24 weeks than at 12 weeks (37% vs 22%)1
Understanding the Data
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While the 50 mg QW arm of the mITT population included 373 patients, 18 patients who reported zero painful and/or swollen joints at baseline were excluded from ACR response analysis.2

Footnotes
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 ‡The PASI is a measure of the average redness, thickness, and scaliness of the psoriatic lesions (each graded on a 0-4 scale), weighted by the area of involvement. PASI is reported on a scale of 0 to 72, where 0 represents no psoriasis lesions and 72 represents 100% body coverage of the worst possible lesions. PASI scores ≥ 10 represent severe psoriasis.

 §PASI 75 = 75% or greater improvement in the Psoriasis Area and Severity Index (PASI) score.

 ||BSA measures the percent of the subject's body covered by psoriasis lesions. BSA involvement ≥10% represents severe psoriasis. In the PRESTA study, 1% body surface area was defined as palm+thumb+other fingers up to the PIP joint.

Study Descriptions
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The PRESTA Study1:

Efficacy in psoriatic arthritis

  • A 24-week, randomized, multicenter, two-period study of 752 patients with active psoriatic arthritis (mean BSA of 30.82), consisting of a 12-week double-blind treatment period followed by a 12-week open-label treatment period
  • All patients had both psoriatic arthritis and moderate to severe chronic plaque psoriasis and were candidates for systemic therapy. Mean duration of psoriatic arthritis was 7.08 years and mean duration of plaque psoriasis was 18.92 years
  • The mITT population of 752 included all patients who received one dose of trial drug and had at least one postbaseline efficacy evaluation
    • The PRESTA study included a limited number of patients with zero painful and/or swollen joint counts at baseline, including 18 of the 373 in the 50 mg QW arm
  • At baseline, 36% of the mITT population (n = 752) had prior MTX use
    • During the trial, 25% of patients received concomitant MTX (mean weekly dose of 12.71 mg)
    • DMARDs and systemic antipsoriasis therapies other than MTX and acitretin were prohibited within 28 days before baseline until the end of the trial
  • Patients were randomized to receive ENBREL 50 mg BIW over the 12-week blinded treatment period followed by ENBREL 50 mg QW over the 12-week open-label treatment period (n = 379) or ENBREL 50 mg QW over both the 12-week blinded treatment period and the 12-week open-label treatment period (n = 373)
  • Subjects were evaluated at baseline and at Weeks 3, 6, 12, 18, and 24
  • The primary efficacy endpoint was the comparison between subjects in the ENBREL 50 mg BIW/QW group and the ENBREL 50 mg QW group for the proportion of subjects achieving a status of clear or almost clear on the Physician Global Assessment (PGA) of psoriasis at Week 12

References

  1. Data on file, Pfizer Inc.
View Study Designs and Descriptions

View the safety profile of ENBREL for psoriatic arthritis

Important Safety Information Prescribing Information Medication Guide
Indications
 
Moderate to Severe Rheumatoid Arthritis Supportive Data Psoriatic Arthritis Supportive Data
Safety Information ISI
See how Phil Mickelson stayed "on course" after a diagnosis of psoriatic arthritis just after the 2010 U.S. Open. See Phil's story

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