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Positive phase III data for Humira in ankylosing spondylitis

Abbott has revealed positive new results of two analyses from a major phase III study of Humira in ankylosing spondylitis, an inflammatory disease of the spine and spinal joints.

The first analysis demonstrated the ability of Humira to maintain the reduction of signs and symptoms in ankylosing spondylitis (AS) patients at 12 weeks through 52 weeks of treatment.

A second analysis demonstrated that Humira rapidly and significantly reduced pain and fatigue in patients with AS as early as two weeks compared with placebo and that the improvement was maintained for at least 24 weeks.

The data from the trial follow the recent approval by the European Commission of Humira as a treatment for severe active AS.

AS is the third of six autoimmune diseases targeted for Humira therapy, including rheumatoid arthritis and psoriatic arthritis. Abbott’s application for Humira for AS in the US is currently under review.

“Humira is a strong option in the AS treatment marketplace through its efficacy, safety and convenient dosing,” said Dr Rebecca Hoffman, divisional vice president of immunology development at Abbott. “With its recent approval for AS in Europe and current indications in RA and PsA, Humira is demonstrating benefits for patients facing these chronic and potentially disabling diseases.”