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Review of the Clinical Information for SIMPONI™ (golimumab) In Rheumatoid Arthritis

Review of the Clinical Information for SIMPONI™ (golimumab) In Rheumatoid Arthritis

This Clinical Brief reviews the clinical information for SIMPONI™ (golimumab), which was approved by the U.S. Food and Drug Administration on April 24, 2009, for the treatment of adults with moderately to severe active rheumatoid arthritis (RA) in combination with methotrexate (MTX). It is also indicated for treatment of adults with active psoriatic arthritis, alone or in combination with MTX, and adults with active ankylosing spondylitis.

Highlights:

  • SIMPONI™ is administered in a one dose, once a month subcutaneously via a prefilled autoinjector or prefilled syringe.
  • SIMPONI™ has been studied in three phase 3 trials that enrolled different patients populations with respect to treatment. These multicenter, randomized, double-blinded, placebo-controlled trials included 1,542 patients age 18 or older with moderately to severely active RA.
  • In these three trials, SIMPONI™ was shown to improve the signs and symptoms in patients with moderately to severely active RA. It also was shown to be efficacious in patients who are incomplete responders or naïve to MTX, as well as those patients who have been previously treated with at least one other anti-tumor necrosis factor agent.

Roy Fleischmann, MD, Clinical Professor of Medicine, University of Texas Southwestern Medical Center, and Co-Medical Director, Metroplex Clinical Research Center, Dallas, discusses this novel agent.

Meetings

Private Health Insurance Exchanges Conference Washington, D.C. October 7–8, 2014
National Healthcare Facility Management Summit Palm Beach, FL October 16–17, 2014
National Healthcare CFO Summit Las Vegas, NV October 19–21, 2014
National Healthcare CXO Summit Las Vegas, NV October 19–21, 2014
Innovative Member Engagement Operations For Health Plans Las Vegas, NV October 20–21, 2014
4th Partnering With ACOs Summit Los Angeles, CA October 27–28, 2014
2014 Annual HEDIS® and Star Ratings Symposium Nashville, TN November 3–4, 2014
PCMH & Shared Savings ACO Leadership Summit Nashville, TN November 3–4, 2014
World Orphan Drug Congress Europe 2014 Brussels, Belgium November 12–14, 2014
Medicare Risk Adjustment, Revenue Management, & Star Ratings Fort Lauderdale, FL November 12–14, 2014
Healthcare Chief Medical Officer Forum Alexandria, VA November 13–14, 2014
Home Care Leadership Summit Atlanta, GA November 17–18, 2014