Abbott (MONTREAL, Canada) announced that it has received approval from Health Canada to market Humira® (adalimumab) as a treatment for active ankylosing spondylitis (AS) in Canada. Humira is indicated for reducing the signs and symptoms in patients with active AS who have had an inadequate response to conventional therapy. It is estimated that AS affects between 150,000 and 300,000 Canadians (as many as one in 100); most patients are males who have been stricken in their 30s and 40s. The approval of Humira for the treatment of AS is based on data from the ATLAS (Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS) trial. ATLAS was a randomized, placebo-controlled, double-blind, phase III study conducted in Europe and the US. Results showed that Humira was successful in reducing pain and inflammation in patients with AS, the study's primary endpoint. Other findings demonstrated the efficacy of Humira in many patients in reducing disease activity and improving physical function and physical quality of life.
Humira is also approved in Canada for the treatment of moderately-to-severely active rheumatoid arthritis and active psoriatic arthritis. To date, Humira has been approved in 65 countries and prescribed to more than 150,000 patients worldwide. Clinical trials are currently underway evaluating the potential of Humira in other autoimmune diseases.
—A. Techman
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