AAD: Raptiva Helps in Psoriasis of Hands and Feet

WASHINGTON, Feb. 2 -- A 12-week course of Raptiva (efalizumab) significantly improved chronic severe plaque psoriasis of the hands and feet, researchers here reported today.

Almost half of the 52 patients who received weekly Raptiva injections had little to no evidence of psoriasis at the end of treatment, said lead investigator Craig Leonardi, M.D., associate professor of dermatology at St. Louis University. This compared with a response rate of 17.9% in a placebo arm (P=0.015),

The double blind study randomized 80 patients with chronic moderate-to-severe plaque psoriasis of the hands or feet, or both, in a 2:1 design to weekly injection Raptiva or saline Dr. Leonardi reported at the American Academy of Dermatology meeting. The primary endpoint was a Physician's Global Assessment (PGA) rating of clear (0), almost clear (1) or mild (2).

Forty-five of the 52 Raptiva patients completed all 12-weeks of treatment as did 21 of 28 patients in the placebo arm. Dr. Leonardi's findings were based on intention-to-treat analysis.

Among the findings:

• After 12 weeks 46.2% of the Raptiva patients achieved PGA ratings of 0, 1, or 2 versus 17.9% of the placebo patients (P=0.015).
• Seventeen (32.7%) of the Raptiva patients had PGA scores of 0 or 1 versus two (7.1%) of the placebo patients (P=0.013).
• Overall, there were no significant differences in adverse events between the two arms. One patient in the Raptiva arm developed both gastrointestinal hemorrhage and lacunar infarction and one serious infection occurred in the placebo arm.

Asked why Raptiva, a humanized antibody approved in 2003 for treatment of chronic moderate-to-severe plaque psoriasis, was not compared with an active treatment, Dr. Leonardi said, the comparison with placebo was the only way to get definitive evidence that Raptiva was effective for this subset of psoriasis.

"This is the first randomized, placebo controlled trial in this specific psoriasis population," he said. He estimated that psoriasis of the hands and feet affects about 10% to 15% of psoriasis patients.

Historically psoriasis of the hands and feet has been a treatment challenge. As a result "we usually just throw everything at it --ultraviolet light, acetritin, methotrexate-but nothing has really worked, and the patients are left just miserable."

On the basis of these findings, he said that Raptiva should be considered for any patient with psoriasis of the hands and feet who does not respond to topical therapy, which should remain the first-line treatments.

But he added that cost was likely to be a factor, since "this is an expensive drug and patients without insurance are not getting this drug."

The estimated cost of a year's therapy with Raptiva is ,000, but typical insurance co-payments "run about to per injection," he said.