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Etanercept (Enbrel) Effective, Safe as Psoriasis Monotherapy, Even in High Doses: Presented at EADV

By Bonnie Darves

BARCELONA, SPAIN -- October 28, 2003 -- A new Phase III study provides further evidence that etanercept (Enbrel) is both effective and safe as first-line monotherapy for the treatment of moderate to severe psoriasis, researchers announced on October 18^th at the European Academy of Dermatology and Venereology Congress.

Reporting on results from the first 24 weeks of the one-year study, Alice Gottlieb, MD, PhD, director of the Clinical Research Center at Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States, said patients taking etanercept in doses of either 25 mg or 50 mg subcutaneously up to twice weekly experienced not only significant symptom reduction but also "dramatic improvement in all quality of life indices used—and the differences with both the 25 mg and 50 mg dose were seen as early as two weeks into treatment, compared with placebo. When you get to 24 weeks there is a 74% [PASI –Psoriasis Area Severity Index] improvement."

The drug is currently undergoing the United States Food and Drug Administration (FDA) approval process for use in rheumatoid arthritis and psoriatic arthritis in adults, Dr. Gottlieb said.

In the placebo-controlled trial, involving 653 patients at 47 centres, patients were randomised to receive 25 mg once weekly, 25 mg twice weekly or 50 mg twice weekly of etanercept for 24 weeks. At week 12, placebo patients switched to 25 mg of etanercept twice weekly until the end of the 24-week study.

The portion of patients who achieved PASI improvement of 75% at 24 weeks was 25% in the 25 mg group, 44% in the 25 mg twice-weekly group and 59% in the 50 mg group. "Sixty-six percent of participants were clear by week 24," Dr. Gottlieb said, noting that some physicians prefer to use that index rather than PASI scores to assess efficacy. "In quality of life improvement, more [etanercept] is not only better, it's faster, and longer [treatment duration] is better. My patients were running around in shorts and were 55% clear at week 12." Dr. Gottlieb added that nails also improved dramatically in those who responded to treatment.

The rate of adverse events was 1% in the study, and adverse events (mostly injection-site reactions) were no more frequent in the higher-dose group than in those taking only 25 mg and did not necessitate stopping treatment. "The drug works, and the high dose is as safe as the low dose," Dr. Gottlieb said.


[Study title: Efficacy and Safety of Enbrel (Etanercept) in Patients With Psoriasis. Podium Presentation FC12-2]

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