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Abbott phase 3 study shows efficacy of Humira in treating ankylosing spondylitis
By Angela McDaniels
Seattle, Nov. 14 - Abbott Laboratories said results from a phase 3 study show that patients with ankylosing spondylitis treated with Humira (adalimumab) had significant reductions in signs and symptoms and improved health-related quality of life.
The placebo-controlled, 24-week study was conducted in the United States and Europe and involved 315 patients with active ankylosing spondylitis who had an inadequate response to at least one non-steroidal anti-inflammatory drug or disease modifying anti-rheumatic drug.
Patients were rated on two scales: the Assessment in AS International Working Group criteria - which evaluates function, pain, the patient's global assessment and inflammation - and the Bath AS Disease Activity Index, which measures pain, stiffness and fatigue.
Scores on both scales were significantly better for patients treated with Humira than those on placebo at both week 12 and 24, the company said.
Patients were also given two health-related quality-of-life questionnaires: the Short Form-36 Health Survey and the AS Quality of Life Questionnaire.
At 12 and 24 weeks, patients treated with Humira reported greater improvement in scores in both questionnaires than those on placebo.
The data was presented Monday at the American College of Rheumatology annual meeting in San Diego.
In October, Abbott submitted a supplemental Biologics License Application with the U.S. Food and Drug Administration and a Type 2 Variation to the European Medicines Agency seeking approval to market Humira as a treatment for ankylosing spondylitis, an inflammatory disease of the spine and spinal joints.
Abbott is based in Abbott Park, Ill., and develops pharmaceuticals and medical device products.
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