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

'There is no cure for ankylosing spondylitis and the goal of therapy is torelieve back and joint pain,' said Desiree van der Heijde, M.D., co-leadinvestigator of ATLAS and Professor of Rheumatology at Leiden UniversityMedical Center, The Netherlands. 'Even partial remission of AS can have aconsiderable positive impact on a patient's symptoms. These data arereassuring for patients because they demonstrate that adalimumab can be aneffective treatment for ankylosing spondylitis.'

Three-Year ATLAS Data Summary

ATLAS was a randomized, placebo-controlled, double-blind, Phase III studyconducted in the U.S. and Europe. The study involved 315 patients with activeAS who had an inadequate response to at least one non-steroidalanti-inflammatory drug (NSAID) or disease modifying anti-rheumatic drug(DMARD). Patients received HUMIRA 40mg subcutaneously or placebo every otherweek (EOW). Results at 12 and 24 weeks showed HUMIRA patients experienced astatistically significant reduction in signs and symptoms according to theAssessment in SpondyloArthritis International Society (ASAS) measure, orASAS20 compared to placebo. ASAS20 represents at least a 20 percentimprovement in at least three of the four assessments to measure patientimprovement and response to therapy. At 24 weeks, all patients were switchedto an open-label HUMIRA 40mg EOW dose trial for an additional 236 weeks.Improvement was observed through three years of treatment.

    Efficacy    --  After three years, 74 percent (174/234) of patients achieved ASAS20.    --  After three years, 42 percent (97/234) of patients achieved ASAS        partial remission.

Physicians measure the severity of AS on a scale of 0-100 for level ofpain, function, inflammation and a general overall assessment by the patient.Partial remission of the disease is classified as a score of less than 20 on a0-100 scale in each of those four assessments.

    Safety    --  The most common adverse experiences occurring in greater than or equal        to five percent of patients during three years of exposure were        nasopharyngitis, upper respiratory tract infection and headache.    --  There were no cases of tuberculosis or demyelinating disorders. There        was one death caused by malignancy.

About Ankylosing Spondylitis (AS)

AS is a rheumatic condition that affects young adults, and is more commonin men than in women. Ankylosis means 'fusion' and spondylitis means'inflammation of the spine.' Advanced AS can lead to new bone formation on thespine causing it to fuse in a fixed position. It commonly begins before theage of 35. It is estimated that nearly three million people in Europe and atleast half a million people in the United States are affected by AS or arelated spondyloarthropathy.