Summary: The FDA has approved the drug Humira for the treatment of rheumatoid arthritis. Humira is a human antibody that blocks a protein known as tumor necrosis factor (TNF), which plays a key role in inflammation.
Comment: This is a big new drug for Abbott Laboratories, the maker of Humira. It joins Enbrel and Remicade as anti-TNF drugs.
FDA Approves New Therapy for Rheumatoid Arthritis
FDA has approved adalimumab (marketed by Abbott Laboratories as HUMIRA) to treat rheumatoid arthritis (RA). This is the second treatment of its kind and may significantly increase the availability of these therapeutics to patients.
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.
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 who 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 adult 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.
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.
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).
Source: FDA Talk Paper, T02-59, December 31, 2002