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Golimumab Phase 3 Data Show Significant Improvement In Physical Function In Patients with Rheumatoid Arthritis
Date:10/27/2008

participating in the study developed malignancies: one patient taking golimumab 100 mg plus methotrexate developed breast cancer, one patient taking placebo plus methotrexate developed Bowen's disease and squamous cell skin cancer, one patient taking golimumab 100 mg plus placebo developed basal cell cancer, and one patient taking golimumab 100 mg plus placebo developed squamous cell carcinoma. One patient receiving golimumab 100 mg plus placebo died from diarrhea, colitis and sepsis.

Anti-TNF therapies have been associated with serious and sometimes fatal risks including the risk of tuberculosis and other serious infections, malignancies, heart failure, central nervous system disorders, reactivation of hepatitis B and other serious events.

About Rheumatoid Arthritis

RA is a chronic and debilitating disease that affects approximately 1.3 million people in the United States and more than three million people in Europe. Signs and symptoms of RA include pain, stiffness and motion restriction in multiple joints. Because RA is a progressive disease, it can cause permanent joint deformity and severe disability if not diagnosed early or if initial treatment is delayed. RA can occur at any age, but is most common in adults 30-50 years old and is two-to-three times more prevalent in women than in men. The cause of RA is unknown, although genetic factors may contribute to the disease.

About Golimumab

Golimumab, the next-generation human anti-TNF-alpha monoclonal antibody from Centocor Inc. and Schering-Plough Corporation, 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 RA, including a study in a methotrexate-naive patient population, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as an every four-week subcutaneous injection and an intravenous (IV) infusion therapy. Golimumab targets and neutralizes both th
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SOURCE Centocor
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Related biology technology :

1. Centocor, Inc. and Schering-Plough Submit Application Requesting Approval of Golimumab in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
2. Medarex Receives Milestone Payment for Submission of Regulatory Application Requesting Approval of Golimumab (CNTO 148) in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
3. Phase 3 studies show golimumab significantly improved signs and symptoms of rheumatoid arthritis
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