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FDA approves TNF-alpha blocker golimumab
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The FDA recently approved golimumab, a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis.
Golimumab (Simponi, Centocor Ortho Biotech) is given subcutaneously and is intended for use in combination with the immunosuppressant drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.
In clinical trials, patients who received the drug for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis.
Golimumab is in a class of drugs that target and neutralize tumor necrosis factor-alpha (TNF-alpha), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue.
Like other TNF-alpha blockers, golimumab labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and invasive fungal infections with use of the drug. The FDA also required a risk evaluation mitigation strategy for golimumab, as it required for other TNF-alpha blockers. The risk evaluation mitigation strategy for golimumab includes a medication guide for patients and a communication plan to help prescriber’s understand the drug’s risks.
The most common adverse reactions to golimumab include upper respiratory tract infection, sore throat and nasal congestion.