PROVE Study Demonstrates Long-Term Safety and Tolerability of Etanercept in Patients with Psoriatic Arthritis

Half of the patients with psoriatic arthritis enrolled in a trial of etanercept continued responding to the medication and complying with treatment guidelines for more than 5 years.

enrolled in a trial of etanercept (Enbrel) continued responding to the medication and complying with treatment guidelines for more than 5 years.

. The mean age of the study group members, who were 54.8% male, was 48.3 years and their mean disease duration was 7.5 years. More than a quarter of the patients (26.1%) used corticosteroids in conjunction with the etanercept, while more than half of them (57.1%) used methotrexate.

Researchers used physical examinations and questionnaires to evaluate cohort members at baseline and at months 6, 12, 18, 30,42, 54 and 66.

In all, 156 patients (51.5%) were still using etanercept, and demonstrating signs of benefit, at the end of 66 months. The mean period of etanercept use was 4 years (standard deviation 1.9 years). Men adhered to treatment significantly longer than women (5.0 vs. 3.9 years; p<.0001). Among those who dropped out of the study, 35.9% cited failure to respond to the medication as their reason for doing so.

After 6 months of treatment, 49% of patients with active synovitis at baseline achieved full remission from joint synovitis, and the mean number of joints with synovitis per patient fell by 81.7%. Among such patients who remained for the duration of the study, 77.6% had no joints with synovitis after 66 months of treatment, while the mean number of joints with synovitis per patient had fallen by 92.6%.

Among polyarticular patients, the mean total Health Assessment Questionnaire score (0—60) decreased 64.8%, from 27.0 (95% confidence interval [CI], 25.9–28.1) to 9.7 (95% CI, 8.5–10.9), after 6 months and 66.6%, from 27.0 to 7.7 (95% CI, 6.2–9.3) after 66 months. The chance that this improvement was random was less than 0.001 in both cases.

Among oligoarticular patients who continued using etanercept until the end of the trial, numeric rating scale patient scores fell 48.6% from baseline to month 66.

Adverse events related to treatment were reported in 177 patients (58.8%) and serious adverse events related to treatment were reported in 53 patients (17.6%).

from daily clinical practice [at multiple medical centers], adherence to etanercept was high [when] observed over 5.5 years and [the medication] was well tolerated.”

patients.

, junior rheumatoid arthritis, plaque psoriasis and ankylosing spondylitis as well as psoriatic arthritis. It blocks the action of TNF-alpha, which is thought to be the master regulator of inflammatory immune response in many parts of the body.