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Data From Two Phase 3 Studies Show Anti-TNF Golimumab Significantly Improved Signs and Symptoms of Rheumatoid Arthritis
Date:6/11/2008

X experienced improvements in disease activity as measured by DAS28. Seventy-six percent of patients in the combined golimumab group were classified as DAS28 (CRP) responders, and 38 percent achieved DAS 28 remission, compared with 61 percent and 28 percent of patients receiving placebo and MTX, respectively (p<0.001 for responders and p=0.031 for remission).

"We are encouraged by the findings of both of these Phase 3 studies," said Robert J. Spiegel, M.D., chief medical officer, Schering-Plough Research Institute. "Golimumab holds great promise as an anti-TNF therapy for patients who may benefit from monthly subcutaneous injections for RA and related rheumatic diseases."

In March 2008, Centocor Inc. and Schering-Plough Corporation (NYSE: SGP) announced that a Marketing Authorization Application (MAA) had been submitted to the European Medicines Agency requesting the approval of golimumab as a monthly subcutaneous treatment for adults with RA, psoriatic arthritis and ankylosing spondylitis. The initial submission and Phase 3 development programs are unprecedented among anti-TNF-alpha therapies, as they mark the first time that an MAA has been proposed for review inclusive of three unique disease states. Golimumab, Centocor's and Schering-Plough's next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every four-week subcutaneous injection and an intravenous (IV) infusion therapy.

About the GO-FORWARD Trial

GO-FORWARD, a Phase 3, multi-center clinical trial included 444 patients with active RA. Adult patients with more than four tender and swollen joints, despite MTX therapy, were randomly assigned to receive golimumab (50 or 100 mg) plus MTX, golimumab 100 mg plus placebo or placebo plus MTX at weeks 0, 4, 8, 12, 16 and 20. Data were assessed at weeks 14 and 24. The co-primary endpoints were percentage of patients achieving ACR 20 response at week 14 and improvement from baseline in HAQ at week 24.

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SOURCE Centocor
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