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| |  ACR: Etanercept Inhibits Radiographic Progression of Psoriatic Arthritis By Bruce Sylvester Special to DG News NEW ORLEANS, LA -- October 28, 2002 -- Etanercept (Enbrel) significantly inhibits radiographic progression of joint destruction, joint space narrowing and bone erosion typical of patients with psoriatic arthritis, researchers report. The radiographic results from a phase 3, one-year extension study were presented as part of an oral presentation at the 66th American College of Rheumatology Annual Scientific Meeting in New Orleans. "Enbrel is the first therapy to reduce signs and symptoms, and inhibit the progression of bone erosions and joint space narrowing associated with psoriatic arthritis, a disease which has unique and distinct radiographic features not seen in rheumatoid arthritis," said Dr. Peter Ory, department of radiology, University of Washington, United States, and lead investigator of the study. Psoriatic arthritis is a chronic inflammatory disease of the joints and connective tissue. The disease combines joint pain and swelling that can lead to crippling debilitation with inflamed and irritated scaly red patches of skin on the body. There are approximately 450,000 patients with psoriatic arthritis in the United States and the disease affects both men and women most commonly between the ages 30 and 50. The investigators originally enrolled 205 subjects with psoriatic arthritis (PsA) in a 24-week, double-blind, placebo-controlled study of etanercept and placebo, which has been previously published (Mease, Arthritis Rheum 2001;44:S90). In that study, the researchers concluded that etanercept was safe and significantly effective for both the arthritis and psoriasis of patients with PsA and was well tolerated. At endpoint, the investigators locked the database and gave the 205 subjects the opportunity to enrol directly into a one-year open-label extension. All subjects enrolled in the extension. The investigators made a comparison of collected radiographic progression images from patients treated with etanercept versus placebo. They evaluated x-rays of hands and wrists at baseline of the original blinded study, at 24 weeks, at initiation of open-label treatment, at one year from original baseline, and at early termination during either part of the study. Radiographic image readers in pairs (who were uninformed of the treatment used in study and chronological order in which the x-rays had been made) read digitized x-rays of hands and wrists. They scored the images for erosions and joint space narrowing using a modified Sharp method. They also evaluate images of distal interphalangeal (DIP) joints. All 205 subjects were included in the radiographic evaluations. The investigators found significantly less radiographic progression in the etanercept group than in the placebo group. At one year, there was inhibition of radiographic progression in the etanercept group (n=101) as compared with the placebo group (n=104). The mean change from baseline in total Sharp score was a reduction in progression of -0.02 units in the etanercept group versus an increase in progression of +1.03 units in the placebo group (p=0.0001). The Sharp method uses a 4-point scale to rate joints according to the severity of erosions and degree of joint space narrowing. The erosion and joint space-narrowing subscores are then added to obtain a total radiographic score. Progression of structural damage was inhibited when measured not only by the total Sharp score, but also by joint erosion scores and joint space narrowing scores. The total mean rate of change in erosion scores was -0.08 units/year for etanercept versus +0.69 units/year for placebo (p < 0.0001). Likewise, for joint space narrowing the total mean rate of change was +0.06 units/year for etanercept versus +0.35 units/year in placebo patients (p = 0.04). Adverse events were similar to those reported in previous clinical trials of etanercept involving subjects with rheumatoid arthritis. The researchers saw no increase in the number of serious adverse events in etanercept subjects compared to placebo subjects. Only the rate of injection site reactions in patients receiving etanercept was statistically different compared to placebo (9 percent with placebo versus 36 percent with etanercept in the placebo controlled phase). "Patients with psoriatic arthritis often exhibit the painful bone and joint destruction and eventual deformities to fingers, hands and wrists which are associated with disability in this disease," said Dr. Ory. "This is the first study to show that an available treatment for psoriatic arthritis can dramatically inhibit the progression of this terrible condition. This is a breakthrough for us as clinicians and, most importantly, for our patients." The research was funded in part by the Immunex Corporation.
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