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MEDI-545 Found Acceptably Safe in Chronic Psoriasis

IFN-α does not appear to have significant role in maintenance of established plaque psoriasis

THURSDAY, April 1 (HealthDay News) -- MEDI-545 -- a fully human anti-interferon-α monoclonal antibody -- appears safe in patients with chronic plaque psoriasis but does not significantly inhibit the type I interferon gene signature in these patients, suggesting that interferon-α (IFN-α) doesn't play a significant role in maintaining the disease, according to research published in the March issue of the Journal of the American Academy of Dermatology.

Robert Bissonnette, M.D., of Innovaderm Research in Montreal, and colleagues analyzed data from 36 individuals with chronic plaque psoriasis. They received one intravenous dose of placebo or MEDI-545 at dosages of 0.3 to 30 mg/kg and were followed for 18 weeks.

The researchers found that adverse events were similar in the treatment and placebo groups; only two were reported. One subject in the 30 mg/kg group had a drug-related hypotensive infusion reaction, and the other subjects slated to receive this dosage weren't treated. The other adverse event was a myocardial infarction in the 10 mg/kg group, but it was considered unrelated to treatment. No antibody response to the treatment was observed in any subject. The researchers also found that the treatment didn't substantially inhibit the type I IFN gene signature in affected skin, and it had no clinical activity.

"In conclusion, the safety profile of MEDI-545, an anti-IFN-α monoclonal antibody, supports future clinical development in diseases associated with elevated type I IFN gene signature and skin manifestations such as lupus, scleroderma, and dermatomyositis," the authors write. "The lack of substantial inhibition of type I IFN-inducible genes suggests that the type I IFN gene signature is not driven by IFN-α in established psoriatic skin lesions."

The study was supported by MedImmune, which employs several of the co-authors. The other co-authors reported financial relationships with MedImmune and other companies.

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