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New Anti-TNF Golimumab Significantly Reduced Signs and Symptoms of Ankylosing Spondylitis According to Phase 3 Study Findings
Date:11/7/2007

unction," said Atul Deodhar, MD, associate professor of medicine, Oregon Health and Science University, Portland, Oregon. "These findings show that golimumab improved both the signs and symptoms of ankylosing spondylitis and patients' physical function, which is promising in the treatment of this systemic inflammatory disease."

Findings from the GO-RAISE study showed that golimumab-treated patients experienced significant functional improvements as measured by the BASFI, a 1 to 10 scale (1 representing no impairment and 10 representing severe impairment), which measures physical function and impairment due to the disease and subsequent improvements as a result of treatment. Patients receiving golimumab 50 mg and 100 mg experienced an average decrease of 1.4 and 1.5 units from baseline in BASFI score, respectively, at week 14, compared with an average increase of 0.1 units among patient receiving placebo (P < 0.001 for both comparisons).

"We are encouraged by the findings from this Phase 3 trial evaluating golimumab as a treatment for ankylosing spondylitis," said Jerome A. Boscia, MD, senior vice president, Clinical Research and Development, Centocor, Inc. "These data suggest golimumab may be an effective treatment option for patients with this chronic, progressive spondyloarthropathy."

About the GO-RAISE Trial

The GO-RAISE trial included 356 patients with active ankylosing spondylitis. Subjects were randomized to receive subcutaneous injections of golimumab 50 mg or 100 mg or placebo every four weeks. The primary endpoint was the proportion of patients achieving ASAS 20 at week 14. At week 16, patients in the placebo or 50 mg group demonstrating less than 20 percent improvement from baseline in both total back pain and morning stiffness measures were switched to either golimumab 50 mg (previously receiving placebo) or golimumab 100 mg (previously receiving golimumab 50 mg).

Through week 24, golimumab was generally well tolerated with f
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SOURCE Centocor, Inc.
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