THURSDAY, Jan. 02, 2003 (HealthDayNews) -- The U.S. Food and Drug Administration has approved the Abbott Laboratories drug HUMIRA (adalimumab) to treat rheumatoid arthritis.
The drug is produced using so-called recombinant DNA technology, a series of techniques for cutting apart and splicing together different pieces of DNA. When segments of foreign DNA are transferred into host cells or organisms like bacteria, the host cells become "factories" for the production of the protein coded for by the inserted DNA.
In HUMIRA's case, the host cells produce an antibody that binds to and blocks the human tumor necrosis factor (TNF), which is involved with the body's normal inflammatory response. People with rheumatoid arthritis have high levels of TNF in the fluid that lubricates their joints, causing the joints to become inflamed.
In a series of four clinical trials, HUMIRA was found to reduce the signs and symptoms of rheumatoid arthritis in more than half of the patients tested. The drug is injected once every other week.
The drug is required to carry a warning that serious, sometimes fatal infections may occur as a result of using TNF-blocking agents, including HUMIRA. Another possible side effect of the medication is cancer of the lymphoid system (lymphoma), the FDA says.
Here is the FDA Talk Paper about the drug. For more about rheumatoid arthritis, visit the Mayo Clinic.
