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Etanercept may be a Feasible Treatment for Plaque Psoriasis

Patients who are treated with etanercept, compared with placebo, were more likely to achieve a significant improvement in symptoms of plaque psoriasis, according to the findings of a phase 3 study conducted at 47 sites in the United States.

Investigators with the Etanercept Psoriasis Study Group conducted a 24-week, double-blind analysis of subcutaneous etanercept or placebo in 672 patients (67% male, mean age of 45.1 years), with clinically stable plaque psoriasis. The study population had a mean affected body-surface area of 28.7%, a mean baseline psoriasis area-and-severity index of 18.4, and 22% had psoriatic arthritis. Previous therapies included topical corticosteroids in 88% and systemic therapy or phototherapy for psoriasis in 76% of the participants.

Of the patients randomised to etanercept, 160 received low-dose (25 mg once weekly), 162 received medium-dose (25 mg twice weekly), and 164 received high-dose (50 mg twice weekly) for 24 weeks. During the first 12 weeks of treatment 166 patients received placebo then switched to medium-dose etanercept for 12 weeks. A total of 652 patients received at least 1 dose of the study treatment.

After 12 weeks of treatment 14% in the low-dose, 34% in the medium-dose, and 49% in the high-dose etanercept groups compared with 4% in the placebo group reached the primary endpoint of a 75% or greater improvement from baseline in the psoriasis index.

After 24 weeks of treatment, 25% of the low-dose, 44% of the medium-dose, and 59% of the high-dose etanercept treated patients reached the primary endpoint. Among the original placebo group, 33% achieved a psoriasis index improvement of 75% or greater over baseline after switching to medium-dose etanercept for the last 12 weeks of the study.

Patients treated with etanercept were more likely to receive a clear or almost clear of psoriasis physician assessment and etanercept treated patients showed more significant improvements in the Dermatology Life Quality Index compared with placebo. Adverse events occurred in similar proportions in all active treatment groups and the placebo group at week 12.

"Although data regarding long-term safety in patients with psoriasis are not available," writes Alice B. Gottlieb, MD, PhD, of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, and colleagues, "the data from patients with rheumatoid arthritis suggest that long-term treatment with etanercept may be a viable option for patients with psoriasis."

N Engl J Med 2003;349:2014-22.

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