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FDA Approves New Drug Humira™ for Rheumatoid Arthritis

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www.ProHealth.com • January 8, 2003


The U.S Food and Drug Administration (FDA) has approved adalimumab, marketed by Abbott Laboratories as Humira ™ for the treatment of rheumatoid arthritis (RA).

Humira is produced by recombinant DNA technology. It is a human-derived antibody that binds to human tumor necrosis factor alpha (TNF alpha). TNF is naturally produced by the body and is involved with normal inflammatory and immune responses. Individuals with rheumatoid arthritis, a disease that affects more than 2 million Americans, have high levels of TNF in the synovial fluid (lubricating fluid in joints). The extra TNF plays an important role in both the pathologic inflammation and the joint destruction that are hallmarks of RA. Humira is the second treatment of its kind and may significantly increase the availability of these drugs to patients.

By working against the inflammatory process, Humira, like other TNF blockers has been shown to be effective in controlling symptoms of the disease. Humira is indicated for reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis that have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be used alone or in combination with methotrexate or other DMARDs.

The efficacy and safety of Humira were assessed in four randomized, double-blind studies in more than 2,000 adult RA patients. Humira was found to reduce signs and symptoms of rheumatoid arthritis in over half the patients. In one of the four studies, patients were treated for a year and then evaluated radiographically. Patients treated with Humira plus methotrexate (MTX) demonstrated less joint deterioration than patients receiving MTX alone.

In these trials some patients experienced an improvement in RA signs and symptoms as early as one week (22 percent, 14/63 patients). American College of Rheumatology (ACR) responses have been seen in some patients out to three years. Humira is approved for use alone or in combination with traditional DMARDs.

"As rheumatologists, our goal in RA treatment is to treat the pain and swelling as well as slow the progression, which is why it's exciting to have a new option with Humira," said 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 trials. "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 is administered as a single subcutaneous injection every other week. The package insert carries a bolded warning stating that serious, sometimes fatal, infections (including cases of tuberculosis and sepsis) have been reported with the use of TNF-blocking agents including Humira. The most serious adverse events associated with Humira are, as with other TNF blockers, serious infections, neurologic effects, and certain malignancies of the lymphoid system. A higher rate of lymphomas was observed than the expected rate in the general population, but RA patients, particularly those with active disease, may be at a higher risk for development of lymphoma. Patients with rheumatoid arthritis should discuss therapy options with their healthcare providers. Humira is administered as a single subcutaneous injection every other week.

Humira is available in a pre-filled syringe that was specially designed for use by patients who may have limited use of their hands as a result of the destructive progression of RA. The syringe has unique plastic wings that are easy to hold and will allow those patients who are prescribed Humira in the pre-filled syringe to self-administer their Humira at home without having to mix or measure their medication. This unique design was reviewed by an independent panel of people with arthritis and health professionals and received the Arthritis Foundation Ease of Use Commendation Seal.

The FDA’s Center for Biologics Evaluation and Research was able to approve this treatment ahead of deadline, reviewing the product within nine months (standard review is a ten-month cycle).



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