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Phase 3 Data Show Intravenous Golimumab Inhibited Radiographic Progression in Patients with Active Rheumatoid Arthritis
Date:11/12/2012

WASHINGTON, Nov. 12, 2012 /PRNewswire/ -- New Phase 3 findings from a Janssen Research & Development, LLC (Janssen)-sponsored study showed treatment with the investigational intravenous (I.V.) therapy golimumab, a tumor necrosis factor (TNF) inhibitor, significantly inhibited radiographic progression in patients with active moderate to severe rheumatoid arthritis (RA) despite treatment with methotrexate.  Analysis of study patients' X-rays showed significant inhibition of the progression of structural damage at week 24 in greater proportions of patients receiving I.V. golimumab plus methotrexate compared with patients receiving placebo plus methotrexate.  The inhibition of structural damage progression was maintained in patients randomized to I.V. golimumab through week 52, and inhibition of structural damage progression was observed at week 52 in patients receiving placebo who crossed over to I.V. golimumab at week 24.  Treatment with I.V. golimumab plus methotrexate also led to improvements in signs and symptoms and disease activity with nearly 60 percent of patients achieving at least a 20 percent improvement in the American College of Rheumatology (ACR 20) score at week 14, the study's primary endpoint, and nearly two-thirds of patients achieving that response at week 52.  These data are being presented at the 2012 Annual Meeting of the American College of Rheumatology.     

In September, Janssen announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of I.V. golimumab in combination with methotrexate for the treatment of adults with moderately to severely active RA.  Golimumab is currently marketed as SIMPONI® (golimumab), a subcutaneous injection approved by the United States Food and Drug Administration (FDA) for the treatment of moderately to severely active RA with the medicine methotrexate, active
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SOURCE Janssen Research & Development, LLC
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