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Infliximab Demonstrates Safety and Efficacy for Treatment of Psoriasis: Presented at AAD

By Alison Palkhivala

SAN FRANCISCO, CA -- March 25, 2003 -- Infliximab therapy provides rapid and safe relief from psoriasis in patients with relatively severe forms of the condition, according to the results of a randomised multicenter trial.

To determine the efficacy of infliximab in the treatment of plaque-type psoriasis, the researchers conducted a randomised, placebo-controlled phase II trial in 248 adults with the condition. They randomised patients in a 1:2:2 ratio to placebo, 3 mg/kg of infliximab or 5 mg/kg of infliximab.

Alice B. Gottlieb, MD, PhD, from the University of Medicine and Dentistry New Jersey - Robert Wood Johnson Medical School Clinical Research Center in New Brunswick, New Jersey, United States presented the results here on March 22^nd at the 61^st Annual Meeting of the American Academy of Dermatology.

All patients had Psoriasis Area Severity Index (PASI) scores of 12 or more, and at least 10% of their body surface areas was affected. They stopped all systemic treatment for psoriasis at least 1 month prior and all topical therapy at least 2 weeks prior to initiation of treatment. During the study period, the only psoriasis treatments patients could use in addition to the study drug were emollients and shampoos containing tars or salicylic acid.

By Week 10, 72% of patients taking 3 mg/kg of infliximab and 88% of patients taking 5 mg/kg of infliximab had at least a 75% improvement in PASI score, compared with 6% of patients on placebo (P<0.001 for both doses of the drug versus placebo).

Headache and pruritis occurred in more than 5% of patients and more commonly in infliximab-treated than placebo patients. Overall, 16% of patients taking infliximab experienced infusion reactions through Week 6.

"It's supersonically fast," said Dr. Gottlieb about infliximab. "A PASI 75 [percent improvement] was achieved by 88% of patients, [and a] PASI 50 [percent improvement was] achieved by 97% of patients in the 5mg/kg group. Five [mg/kg] was better than 3 [mg/kg]."

"There were no surprises in toxicity," she added. "The infusion reaction rate was similar to that seen with Crohn's disease and rheumatoid arthritis patients."

"I hope to put all my patients on a biologic, and I will leave it up to my patients to decide which biologic they want. I plan to offer all the FDA-approved biologics to my patients," she concluded.


[Study title: Infliximab in the Treatment of Psoriasis: Results from the First 10 Weeks of the Phase II Trial. Abstract p596]

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