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Data Show that Abbott's HUMIRA(R) (adalimumab) Reduced the Signs and Symptoms of Ankylosing Spondylitis Up to Three Years
Date:6/12/2008

PARIS, June 13 /PRNewswire-FirstCall/ -- Abbott announced new data from the open-label extension of the ATLAS (Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS) phase III clinical trial, which showed HUMIRA(R) (adalimumab) reduced the signs and symptoms of ankylosing spondylitis (AS) for up to three years of treatment among 74 percent of patients tested. AS is a type of arthritis that primarily causes inflammation of the spine and the spinal joints. These data were presented at the European League Against Rheumatism (EULAR) annual meeting in Paris.

"There is no cure for ankylosing spondylitis and the goal of therapy is to relieve back and joint pain," said Desiree van der Heijde, M.D., co-lead investigator of ATLAS and Professor of Rheumatology at Leiden University Medical Center, The Netherlands. "Even partial remission of AS can have a considerable positive impact on a patient's symptoms. These data are reassuring for patients because they demonstrate that adalimumab can be an effective treatment for ankylosing spondylitis."

Three-Year ATLAS Data Summary

ATLAS was a randomized, placebo-controlled, double-blind, Phase III study conducted in the U.S. and Europe. The study involved 315 patients with active AS who had an inadequate response to at least one non-steroidal anti-inflammatory drug (NSAID) or disease modifying anti-rheumatic drug (DMARD). Patients received HUMIRA 40mg subcutaneously or placebo every other week (EOW). Results at 12 and 24 weeks showed HUMIRA patients experienced a statistically significant reduction in signs and symptoms according to the Assessment in SpondyloArthritis International Society (ASAS) measure, or ASAS20 compared to placebo. ASAS20 represents at least a 20 percent improvement in at least three of the four assessments to measure patient improvement and response to therapy. At 24 weeks, all patients were switched to an open-label HUMIRA 40mg EOW dose trial for an additional 236 weeks. Impr
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