June 18, 2003

      The U. S. Food and Drug Administration (FDA) has approved the marketing of HumiraTM (pronounced hue-mare-uh). Developed by Abbott Laboratories, Humira is the first human monoclonal antibody approved for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active rheumatoid arthritis who have had sufficient response to one or more traditional disease modifying antirheumatic drugs (DMARDs). Humira is approved for use alone or in combination with traditional DMARDs and will offer every-other-week dosing by subcutaneous injection (shot beneath the skin). A specially designed prefilled syringe for rheumatoid arthritis patients whose hands may be affected by crippling joint destruction are available in pharmacies.

      The approval of Humira was based on the efficacy and safety data obtained in four controlled clinical trials in more than 2,000 rheumatoid arthritis patients. Michael Schiff, M.D, director of clinical research, Denver Arthritis Clinic, clinical professor of medicine, Rheumatology Division, University of Colorado School of Medicine and a lead investigator for Humira clinical trails, commented, "In my experience with Humira, some patients see a rapid improvement in their signs and symptoms as early as one week, which allows them to participate in normal daily activities. Just as important is the ability of Humira to inhibit the progression of the disease, which means it slows the damage to the joints that occurs over time."

      Humira resembles antibodies normally found in the body. It works by specifically blocking tumor necrosis factor alpha (TNFa), a protein that plays a central role in the inflammatory responses of autoimmune diseases such as rheumatoid arthritis. TNF-blocking agents, including Humira, have been associated in rare cases with exacerbation of demyelinating disease. The most frequent adverse events seen in the placebo-controlled clinical trials (Humira vs. placebo) were upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent), and sinusitis (11 percent vs. 9 percent). Cases of tuberculosis (TB), frequently disseminated or extra pulmonary at clinical presentation, have been observed in patients receiving Humira. Discontinuations due to adverse events were 7 percent for Humira, 4 percent for placebo.

      As with any treatment program, the benefits and risks of Humira should be carefully considered before initiating therapy.