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One-Year Data Show Golimumab Improved Signs and Symptoms In Patients with Psoriatic Arthritis In Phase 3 Study
Date:10/27/2008

ients experienced SAEs and no tuberculosis or opportunistic infections were reported. Between weeks 24 and 52, one colon and one small cell lung cancer were reported. The small cell lung cancer patient died; another patient died in a climbing accident. Through one year, golimumab had a similar safety profile to the first 6 months.

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 Psoriatic Arthritis

Psoriatic arthritis is a chronic inflammatory arthropathy manifesting with joint pain and swelling that can lead to joint destruction and debilitation. It is frequently associated with inflamed, scaly, red patches of skin psoriasis and psoriasis nail involvement. Symptoms may include stiffness and tenderness of the joints and surrounding tissue and reduced range of motion. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected. Psoriasis affects an estimated two to three percent of the world's population, and approximately one out of three patients affected by psoriasis may develop psoriatic arthritis. Both men and women are equally affected by psoriatic arthritis, most commonly between the ages 30 and 50, in the peak of their productive years.

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 rheumatoid arthritis (RA), 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 the soluble and membrane-bou
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SOURCE Centocor
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1. Phase 3 studies show golimumab significantly improved signs and symptoms of rheumatoid arthritis
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. Centocor, Inc. and Schering-Plough Submit Application Requesting Approval of Golimumab in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
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