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Etanercept Safe, Well Tolerated in the Elderly


 

The safety of the biologic etanercept (Enbrel) doesn't appear to vary depending on the age of the patient taking it for a rheumatic disease, according to the findings from a review of 22 clinical trials.

The investigation, by Roy Fleischmann, M.D., of the University of Texas Southwestern Medical Center at Dallas, and his colleagues, examined data on 3,893 subjects with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Most of the clinical trials were controlled, with control patients taking either placebo or methotrexate (Ann. Rheum. Dis. [online] Sept. 21, 2005; http://ard.bmjjournals.com/onlinefirst.shtml

Significantly more subjects aged 65 years and older reported adverse events and serious adverse events whether they were treated with etanercept or not. The rate of medically important adverse events was higher in elderly users and nonusers of the biologic (10% and 7%, respectively), compared with younger users and nonusers (4% and 1%).

But when the data were analyzed to take into account event rates associated with etanercept among control subjects, the only statistically significant difference was a higher proportion of infectious events in younger subjects.

The study was funded by Immunex Corp. and by Wyeth, the manufacturers of etanercept.

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