Humira, Drug for Rheumatoid Arthritis

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.

Barbara K. Hecht, Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com


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.