Etanercept Monotherapy Helpful in Psoriasis

December 16, 2003

Laurie Barclay, MD

Dec. 15, 2003 ‹ Etanercept monotherapy had a favorable safety profile and

significantly benefitted patients with psoriasis, according to the results

of a randomized, placebo-controlled trial published in the December issue of

the Archives of Dermatology.

" Based on molecular and clinical evidence, T cells, especially T1 cells, and

the cytokines they release appear to be critical mediators of the symptoms

of plaque psoriasis, " write Alice B. Gottlieb, MD, PhD, from the University

of Medicine and Dentistry of New Jersey Wood Medical School,

New Brunswick, and colleagues. " Clinical studies using agents that block

tumor necrosis factor (TNF) activity support the hypothesis that TNF

activity has an important role in psoriasis. "

In this double-blind, multicenter study conducted at outpatient private

practice and university dermatology research centers, 112 patients were

randomized to receive placebo or etanercept, 25 mg subcutaneously twice

weekly for 24 weeks. Other psoriasis treatments were limited during the

study. The primary end point was a 75% improvement in the Psoriasis Area and

Severity Index (PASI).

After 12 weeks of treatment, 17 (30%) of the 57 etanercept-treated patients

and one (2%) of the 55 placebo-treated patients had achieved PASI 75% (P <

..001). After 24 weeks, 32 etanercept-treated patients (56%) and three

placebo-treated patients (5%) had achieved this end point (P<.001).

By 24 weeks, physician global assessment revealed that psoriasis was clear

or minimal in more than 50% of the etanercept group. Treatment failure,

defined as PASI response less than 50%, occurred in 23% of patients.

However, etanercept had a beneficial effect on other efficacy measurements,

including patient global assessments and quality-of-life measures. Adverse

events were not significantly different between groups.

" Etanercept monotherapy provided significant benefit to patients with

psoriasis and had a favorable safety profile, " the authors write. " The

efficacy of etanercept, which blocks the effect of TNF, in the treatment of

psoriasis is particularly interesting in light of increasing clinical

evidence that disruption of specific interactions within the immune system

can improve psoriasis.... Etanercept may prove to be an effective and safe

long-term monotherapy for this chronic disease. "

Immunex Corp, a subsidiary of Amgen, Inc., sponsored this study.

Arch Derm. 2003;139:1627-1632

Reviewed by D. Vogin, MD

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