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Five-Year SIMPONI Data Reported In Treatment Of Signs And Symptoms Of Moderately To Severely Active Rheumatoid Arthritis
Date:6/12/2013

MADRID, June 12, 2013 /PRNewswire/ -- Janssen Biotech, Inc. announced today new five-year data from three pivotal Phase 3 studies evaluating SIMPONI® (golimumab) 50 mg administered subcutaneously once every four weeks in the treatment of moderately to severely active rheumatoid arthritis (RA).  The new findings from open-label, long-term extensions of the pivotal registration trials are results from the use of SIMPONI in several RA populations.  The populations studied included patients naive to methotrexate, patients with active disease despite methotrexate (MTX) and patients who had previously received anti-tumor necrosis factor (anti-TNF) agents.  Among patients continuing treatment with SIMPONI 50 mg in combination with methotrexate or other disease-modifying antirheumatic drugs (DMARDs) through five years, between 60 and 85 percent of patients experienced at least a 20 percent improvement in American College of Rheumatology criteria (ACR 20) at the end of the treatment period. The findings are being presented at the 2013 European League Against Rheumatism (EULAR) Annual Congress."These five-year data are important and provide rheumatologists insights into how patients living with a chronic inflammatory disease like rheumatoid arthritis may respond over time," said Josef Smolen, M.D., Professor and Chairman, Department of Rheumatology, Medical University of Vienna, Vienna, Austria and lead study investigator.  "Golimumab continues to be an important therapeutic option for patients living with moderately to severely active rheumatoid arthritis."

Five-year Safety and Efficacy of Golimumab in Methotrexate-naive Patients with Rheumatoid Arthritis: Final Study Results of the Phase 3, Randomized, Placebo-controlled GO-BEFORE Trial
An analysis using observed data from the Phase 3 GOlimumab Before Employing meth
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SOURCE Janssen Biotech, Inc.
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