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

rexate alone (P < 0.05). The SF-36 is a 36-item questionnaire that assesses impact in eight areas: physical functioning, pain, vitality, social functioning, psychological functioning, general health perceptions and role limitations due to physical and emotional problems. Lower scores indicate poorer functioning and well- being.

The Biologics License Application (BLA) and Marketing Authorization Application (MAA) for golimumab were submitted earlier in the year and are currently under review by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA), respectively. The filings are based on the extensive clinical development program for golimumab, including data from five pivotal Phase 3 trials in RA, psoriatic arthritis and ankylosing spondylitis.

About the GO-AFTER Trial

GO-AFTER was a Phase 3, multi-center, double-blind trial that included 461 patients with active RA of 8.65 years mean duration. All patients had previously received at least one anti-TNF agent, with 25 percent (n=115) having been treated with two therapies and 9 percent (n=43) with three. Discontinuation of previous anti-TNF therapy was due to lack of efficacy (58 percent), intolerance (17 percent) and other reasons (40 percent). Patients were randomized to one of three treatment groups: subcutaneous placebo, golimumab 50 mg or golimumab 100 mg every four weeks. At baseline, 66 percent of patients were receiving methotrexate; 5 percent and 7 percent of patients were receiving sulfasalazine and hydroxychloroquine, respectively. Patients continued to receive stable doses of methotrexate, sulfasalazine and/or hydroxychloroquine if receiving them at baseline.

Golimumab was generally well tolerated in this study. Through week 24, 72 percent, 66 percent and 78 percent of patients in the placebo, golimumab 50 mg and golimumab 100 mg groups, respectively, experienced at least one adverse event (AE). Ten percent of patients in the placebo group experienced
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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
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