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SIMPONI(TM) (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Date:4/24/2009

moderately to severely active rheumatoid arthritis
  • Alone or in combination with methotrexate for the treatment of adult patients with active psoriatic arthritis
  • For the treatment of adult patients with active ankylosing spondylitis

  • SIMPONI is available in two dosage forms. The SIMPONI SmartJect(TM) is a novel autoinjector designed to meet the needs of arthritis patients that has received the Ease-of-Use Commendation by the Arthritis Foundation. SIMPONI is also available as an easy to use prefilled syringe.

    The efficacy and safety of SIMPONI have been evaluated in one of the most comprehensive clinical development programs for an anti-TNF-alpha therapy, which included simultaneous studies in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The program, which includes more than 2,000 patients across five pivotal Phase 3 trials, served as the primary basis for FDA approval. In rheumatoid arthritis, SIMPONI has been studied in a broad range of patients, including adults naive to methotrexate, adults responding inadequately to methotrexate and adults previously treated with at least one anti-TNF-alpha agent. In each of the three trials, significantly more patients receiving SIMPONI 50 mg plus methotrexate achieved at least a 20 percent improvement in arthritis symptoms (ACR20), compared with patients receiving placebo plus methotrexate and/or other disease modifying anti-rheumatic drugs. Improvements were seen as early as four weeks after the first SIMPONI injection and continued to improve over time. A proportion of patients also achieved substantial improvements in arthritis symptoms, 50 percent improvement (ACR50) and 70 percent improvement (ACR70), with continued SIMPONI treatment.

    A Phase 3 trial, the largest of its kind, evaluating SIMPONI in the treatment of psoriatic arthritis showed that SIMPONI 50 mg significantly improve
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    SOURCE Centocor Ortho Biotech Inc.
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