US health care major Abbott Laboratories says that data from a Phase III trial of Humira (adalimumab), its tumor necrosis factor targeting therapeutic in ankolysing spondylitis, demonstrated that the drug rapidly reduces the symptoms and pain associated with the condition, in comparison to placebo. Further analysis of the trial results showed that benefits conferred by treatment were maintained from week 12 to 42 of the study.
The results are derived from the Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS), which was a randomized, placebo-controlled, double-blind Phase III assessment of Humira's efficacy in treating the condition in 315 patients with active AS. After 12 weeks, approximately 60% of those given the drug had achieved a 20% reduction in symptoms (ASAS 20). In addition, after 24 weeks, patients were eligible to enroll in an open-label extension of the program, data from which revealed that after one year of additional treatment, 74% of the subjects had shown a 20% clinical response.
Abbott presented the findings at the annual European League Against Rheumatology congress in Amsterdam, the Netherlands, last week, following Humira's recent approval by the European Medicines Agency (EMEA) for the treatment of severe active AS. The company added that the drug, which is also indicated for use in rheumatoid and psoratic arthritis, is under US Food and Drug Administration review for approval in the AS indication.
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