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Etanercept Efficacy For Psoriatic Arthritis Sustained at Two Years: Presented at ACR

By Bruce Sylvester

ORLANDO, FL -- October 30, 2003 -- Etanercept remains well tolerated and effective for reducing signs and symptoms of psoriatic arthritis and psoriasis for up to 106 weeks, researchers reported here October 28^th at the American College of Rheumatology 67^th Annual Scientific Meeting.

"Etanercept works dramatically to improve joint and skin manifestations of psoriatic arthritis and also inhibits radiographic progression of the disease," said lead investigator Philip Mease, MD, chief of the clinical rheumatology research division, Swedish Hospital Medical Center, Seattle, Washington.

This research extends the findings out to the 2-year mark, and shows a sustained effect over the 2-year period as well as further improvement in the skin manifestations found in a number of patients."

Investigators enrolled 205 subjects in the original 24-week, double blind, placebo controlled study. When the patients completed 24 weeks and the database was locked, 81 originally treated with placebo and 88 originally treated with etanercept were enrolled directly into a 1-year open-label extension. Mean etanercept use for patients initially on placebo was 45 weeks, and it was 80 weeks for patients initially on etanercept (maximum 106 weeks).

Standard American College of Rheumatology (ACR) criteria were used to evaluate severity of arthritis. The researchers evaluated psoriasis by target lesion score and the Dermatologist Static Global Assessment (DSGA) of target lesions. For patients with psoriasis at baseline of greater than or equal to 3% of body surface area, the researchers used the Psoriasis Area and Severity Index (PASI).

Results show that subjects on continued etanercept treatment sustained improvements in both arthritis and psoriasis. Placebo subjects showed improvement when they began etanercept therapy.

At 48 weeks of the extension, 75 subjects who were always treated with etanercept and 70 who were originally treated with placebo remained on treatment. The investigators reported that 66% achieved an ACR 20, 47% achieved an ACR 50, and 16% achieved an ACR 70. Also, 28% of patients had no tender joints, 26% had no swollen joints, and 39% had a Health Assessment Questionnaire (HAQ) disability score of zero. The HAQ includes measures of vitality and questions regarding activities of daily living.

At 48 weeks, 57% of patients had a target lesion assessment of "clear" or "almost clear." Of the 91 PASI-evaluated subjects, 67% achieved a 50% improvement from baseline in the PASI, and 38% achieved a 75% improvement.

Etanercept was well tolerated. During the original 24-week study, the rates per patient-year of serious adverse events were 0.14 for etanercept and 0.25 for placebo. The rate per patient-year for all exposure to etanercept was 0.11. Infections did not increase with extended etanercept treatment.

"These study results underline the value of sustained inhibition of disease activity with [anti-tumour necrosis factor] therapy. And the safety profile remained very good relative to other types of medications," Dr. Mease said.

The study was supported by Immunex Corporation, a subsidiary of Amgen Inc., and by Wyeth.


[Study title: Continued Efficacy and Safety of Etanercept (ENBRELŪ) in Patients With Psoriatic Arthritis and Psoriasis. Abstract 343]

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