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Title: Sustained Improvement Seen With Adalimumab Therapy for Psoriasis: Presented at AAD

"Sustained Improvement Seen With Adalimumab Therapy for Psoriasis: Presented at AAD"

By Ed Susman NEW ORLEANS, LA -- February 21, 2005 -- Seventy percent of patients with severe chronic plaque psoriasis achieved sustained improvement from their skin disease by undergoing injections with the targeted therapy adalimumab. Adalimumab is a fully human monoclonal antibody that acts as a tumor necrosis factor-alpha antagonist. It is approved in the United States and other countries for reducing the signs and symptoms and improving physical function in people with rheumatoid arthritis and is being investigated for use in psoriasis. "Patients treated with adalimumab demonstrated sustained efficacy [at] up to 60 weeks of therapy," said Richard Langley, MD, research director in dermatology at Dalhousie University, in Halifax, Nova Scotia, Canada. Dr. Langley presented the study results at a poster discussion session on February 19[^th at the 63^rd annual meeting of the American Academy of Dermatology.

Dr. Langley and colleagues examined outcomes in patients enrolled in a 48-week extension trial that followed a 12-week double-blind, placebo-controlled trial that tested two dosing levels of adalimumab against placebo. The extension study included a second blinded study in which all patients were on active drug, and that was followed by a 24-week open-label study.

There were 148 patients in the first trial; eventually 132 patients enrolled in the extension trial that looked at long-term efficacy and safety of treatment with adalimumab. The group included 46 patients who were originally in the placebo arm but were transferred to an adalimumab arm after 12 weeks; 40 patients who were taking adalimumab every other week; and 44 patients taking adalimumab weekly. After 60 weeks, 67% of patients receiving adalimumab 40 mg by injection every other week and 73% of patients receiving adalimumab 40 mg by injection every week had achieved a Psoriatic Area and Severity Index (PASI) 75 -- a measure of improvement of the signs and symptoms of psoriasis. All patients receiving adalimumab received an 80 mg loading dose and then 40 mg doses thereafter.

"A PASI 75 means that you can run around naked and no one can tell you have psoriasis," said Alice Gottlieb, MD, professor of medicine and the director of the Clinical Research Center at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, New Jersey. Psoriasis is an immune-mediated disorder characterized by inflammation and thickening of the epidermis causing thick scaly plaques on the skin.

Dr. Langley said that the patients in the trial would continue to be followed.

"This study is another example showing that these biological agents do work to relieve symptoms of psoriasis," said Phoebe Rich, MD, clinical associate professor of dermatology at the Oregon health Sciences University, in Portland, Oregon. "However, long-term studies of the safety of these drugs need to be performed because we really have no long-term data on the safety of these drugs -- most of which will have to be taken by patients for many years."

According to Dr. Langley, the 60-week data revealed no new unexpected safety concerns but did show that one problem seen in the early studies -- injection site reactions -- seem to disappear. "After 60 weeks, injection site problems become a non-issue with these patients," he said.

The study is supported by Abbott Laboratories, Abbott Park, Illinois.

[Study title: Long-term safety and efficacy of adalimumab in the treatment of moderate to severe chronic plaque psoriasis. Abstract P8]

Access by news media is prohibited to numerous sessions of the American Academy of Dermatology annual meeting. This report is based on a presentation for which coverage was permitted by the Academy.

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