SAN FRANCISCO, November 11, 2001 Phase 3 results of ENBREL (etanercept) studied in patients with psoriatic arthritis will be presented this week at the 65th Annual American College of Rheumatology National Scientific Meeting in San Francisco.
Psoriatic arthritis is a devastating disease for which there are currently no approved treatments, says Philip Mease, MD, Seattle Rheumatology Associates, Swedish Medical Center Division of Clinical Research and Clinical Professor, University of Washington. These data, currently under review by the FDA, indicate that ENBREL can significantly improve the signs and symptoms of psoriatic arthritis in many patients.
This 24-week, multicenter, randomized, double-blind, placebo-controlled study assessed the efficacy and tolerability of ENBREL (25-mg twice-weekly subcutaneous injections) or placebo in 205 patients with psoriatic arthritis. The primary endpoint was measured by the proportion of patients who met the American College of Rheumatology preliminary criteria for improvement (ACR20), which includes duration of morning stiffness, tender and swollen joint counts and a patient as well as a physician global assessment. In addition, two other measurements were utilized to study aspects of both the joint and skin manifestations of psoriatic arthritis:. 1) The Psoriatic Arthritis Response Criteria (PsARC) measures improvement in tender and swollen joint score, along with a series of global assessments; and 2) a subset of clinical study patients was measured by improvement in the psoriasis area and severity index (PASI). PASI measures improvement in both the amount of psoriatic plaque throughout the body, as well as the severity of the disease.
Results from the study include: