JointHealth™ express   December 13, 2013

Health Canada approves IV form of golimumab (Simponi®) for the treatment of rheumatoid arthritis (RA)

Health Canada approves IV form of golimumab for RA

Health Canada recently approved the IV form of golimumab (Simponi®) for the treatment of adults with moderate to severe active rheumatoid arthritis in combination with methotrexate.

The approval came as a result of findings from the Phase 3 Trial of Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy (GO-FURTHER). The study observed 592 patients with moderately to severely active RA who had at least six tender and six swollen joints at screening and baseline, had elevated C-reactive protein (CRP) levels at screening, and who had been receiving background methotrexate for at least three months.

Dr. Edward Keystone of Mount Sinai Hospital commented on Health Canada’s approval: “The approval of golimumab for infusion offers patients living with moderately to severely active RA a new and effective treatment option with an infusion time of 30 minutes. In addition, it is dosed based on weight, which means it can offer patients a more tailored option. Having an additional treatment that addresses the signs and symptoms of the disease and can also inhibit the progression of structural damage is critical for rheumatologists in meeting the needs of people living with this potentially disabling disease.”

Rheumatoid arthritis is an autoimmune disease with hallmark symptoms of inflammation and resulting pain. It is a disease process (like cancer or diabetes) where the body's immune system mistakenly attacks its own healthy joints. It is a relatively common disease-approximately 300,000 or 1 in 100 Canadians get it-and is often devastating to a person's body if not treated properly. The disease process causes swelling and pain in and around joints and can affect the body's organs, including the eyes, lungs, and heart. Rheumatoid arthritis most commonly affects the hands and feet. Other joints often affected include the elbows, shoulders, neck, jaw, ankles, knees, and hips. When moderate to severe, the disease reduces a person's life span by as much as a dozen years.

To view the Notice of Compliance, please click here and search for "Simponi".