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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

Patients with Painful and Progressive Form of Inflammatory Spinal Arthritis

Receiving Monthly Golimumab Treatment Showed Marked Improvements in

Physical Function

BOSTON, Nov. 7 /PRNewswire/ -- More than half of patients receiving monthly subcutaneous (SC) injections of golimumab (CNTO 148) 50 mg and 100 mg experienced significant and sustained improvements in the signs and symptoms of active ankylosing spondylitis, according to Phase 3 study results presented at the American College of Rheumatology (ACR) annual meeting. At week 14 of the study, 59 percent of patients receiving golimumab 50 mg and 60 percent of patients receiving golimumab 100 mg achieved at least 20 percent improvement in the Assessment in Ankylosing Spondylitis criteria (ASAS 20) compared with 22 percent of patients receiving placebo (P < 0.001). Investigators also reported that study subjects receiving golimumab 50 mg or golimumab 100 mg showed significant, sustained improvements in physical function through six months as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI).

Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy.

"The rapid and significant effects of golimumab as demonstrated by these study findings are encouraging for the rheumatology community and for the patients living with this debilitating disease," said Jurgen Braun, MD, lead physician at the Rheumatological Center in Herne, Germany, professor at the Ruhr-Universitat of Bochum, Germany, and lead study inves
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SOURCE Centocor, Inc.
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