ENBREL demonstrated rapid and sustained improvements in signs, symptoms, and CRP

THE PSORIATIC ARTHRITIS PIVOTAL TRIAL^1-4:

• Multicenter, double-blind, phase 3 trial of 205 patients with active PsA
• 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 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 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 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 a 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