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.
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.