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Infliximab And Etanercept Both Effective In Treating Ankylosing Spondylitis: Presented at ACR

By Emma Hitt

NEW ORLEANS, LA -- October 30, 2002 -- Infliximab (Remicade) and etanercept (Embrel) both appear to be effective in treating ankylosing spondylitis (AS), according to the findings of two new phase III randomized trials

Dr. Jan Brandt, with the Benjamin Franklin Hospital, Free University, Berlin, Germany, and colleagues presented their findings at the American College of Rheumatology (ACR) 66^th Annual Scientific Meeting here on Monday.

Previous data had suggested that infliximab, a monoclonal antibody to TNF-alpha, might have efficacy over three months in patients with active and severe AS, but the researchers point out that the long-term benefit is uncertain.

Dr. Brandt and colleagues conducted a 54-week randomized trial of 69 patients. Of these, just over half of those taking infliximab experienced a 50 percent regression of disease activity compared to only 9 percent of placebo (p<0.001) during that time.

The researchers report that the magnitude of improvement was sustained in every outcome measure assessed until week 54. A total of 77 percent of patients participated until the end of the trial.

The results are "a major breakthrough" in the treatment of AS, conclude the researchers, although they point out that infliximab may cause "uncommon but potentially untoward side effects." Consequently, they recommend that the treatment be performed in cooperation with experienced rheumatologic centers.

Their second study, an intention-to-treat primary efficacy analysis, suggested that etanercept may also benefit patients with AS. Eight out of 14 patients (57 percent) treated with etanercept achieved a 50 percent regression of disease activity at week 6 compared to only one of 16 (6 percent) patients taking placebo (p=0.004), they found.

"In comparison to infliximab, improvement starts (more slowly) and is maintained for a shorter period of time upon treatment with etanercept," they point out. In contrast, etanercept caused fewer side effects than did infliximab.

"Taken together, etanercept seems to be another promising treatment option for patients with active AS," the researchers conclude.

The infliximab study was funded by Essex Pharma, Munich, Germany, and the etanercept study was funded by Wyeth Immunex, Munster, Germany.

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