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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

tigator. "Anti-TNF therapies have dramatically advanced our approach to the management of this disease, and these data demonstrate the potential of golimumab as a new efficacious anti-TNF-alpha treatment option."

According to findings from the Golimumab - A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks (GO-RAISE) trial, 59 percent of patients receiving golimumab 50 mg and 60 percent of patients receiving golimumab 100 mg achieved the primary endpoint of the study, ASAS 20 at week 14, compared with 22 percent of patients receiving placebo (P < 0.001 for both comparisons). Clinical benefit was demonstrated as early as week four after one dose and was maintained through week 24. At six months, 56 percent of patients receiving golimumab 50 mg and 66 percent of patients receiving golimumab 100 mg achieved ASAS 20 compared with 23 percent of patients receiving placebo (P < 0.001 for both comparisons). Furthermore, at six months, 44 percent of patients receiving golimumab 50 mg and 54 percent of patients receiving golimumab 100 mg achieved ASAS 40, defined as 40 percent improvement in ankylosing spondylitis signs and symptoms, compared with 15 percent of patients receiving placebo (P < 0.001 for both comparisons).

Importantly, at six months, 51 percent of patients receiving golimumab 50 mg and 48 percent of patients receiving golimumab 100 mg achieved a 50 percent reduction in disease activity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50), a standard measure for assessing ankylosing spondylitis disease activity, compared with 15 percent of patients receiving placebo (P < 0.001). The BASDAI measures important markers of disease activity, including pain, morning stiffness and joint swelling.

"When treating this potentially progressive and debilitating disease, we attempt to reduce pain and other symptoms so that patients can maintain or improve physical f
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SOURCE Centocor, Inc.
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