efalizumab

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NEW YORK, NY -- August 3, 2004 -- Results of an ongoing, open-label,

multicenter, phase 3 trial show that the efficacy of efalizumab, a

monoclonal antibody, is maintained for 30-month in patients with

moderate-to-severe plaque psoriasis.

Alice B. Gottlieb, MD, W.H. Conzen Chair in Clinical Pharmacology, Director,

Clinical Research Center, and Professor of Medicine and Associate Chair for

Research, Department of Medicine, University of Medicine and Dentistry of

New Jersey - Wood Medical School, New Brunswick, New Jersey,

presented results here July 31st at the American Academy of Dermatology

Annual Summer Scientific Meeting.

Three phase 3 trials have demonstrated that continuation of efalizumab

treatment for up to 6 months can maintain and sometimes improve the clinical

response achieved after 3 months of therapy, Dr. Gottlieb said.

An ongoing, open-label, multicenter phase 3 trial divided into an initial

3-month treatment period followed by up to 33 months of maintenance

treatment is evaluating the efficacy, safety, and pharmacokinetics of

long-term efalizumab therapy in patients with moderate-to-severe chronic

plaque psoriasis. Dr. Gottlieb reported preliminary results for patients

receiving up to 30 months of continuous therapy.

Efficacy was maintained throughout 30 months of continuous efalizumab

therapy. After 12 weeks of treatment, 41% of patients achieved 75%

improvement in the Psoriasis Area and Severity Index (PASI) and 13% achieved

PASI improvement of 90%. At month 30, patients were able to maintain the

mean percentage of PASI improvement achieved at week 12 relative to

baseline.

Efalizumab was well tolerated throughout 30 months of continuous treatment.

There was no increase in overall incidence of adverse events over time, and

no new common adverse events (5% or greater) emerged during long-term

treatment. During maintenance therapy, common adverse events (occurring in

5% or more of patients during any 12-week treatment period) included

accidental injury, nonspecific infection (for example, colds), increased

cough, rhinitis and sinusitis. Few patients withdrew due to adverse events

(3.1% or less) during each 3-month maintenance period.

Dr. Gottlieb concluded that improvements in psoriasis symptoms achieved

after 3 months of efalizumab therapy were sustained throughout 30 months of

continuous dosing, the longest continuous treatment data for psoriasis

patients receiving a biological agent.

Szczygiel

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