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1/2/2003

FDA Approves Humira for Patients With Rheumatoid Arthritis

Kate Traynor

Abbott Laboratories Inc. announced recently that the Food and Drug Administration has approved the marketing of Humira, or adalimumab, a recombinant human monoclonal antibody to tumor necrosis factor (TNF) alpha.

According to the product's labeling (PDF), adalimumab is indicated for reducing the signs and symptoms of rheumatoid arthritis and inhibiting the progression of structural damage in adults whose disease is moderately to severely active and has not responded adequately to at least one disease-modifying antirheumatic drug (DMARD).

Abbott said it expects to have the product available for use by mid-January.

Designed for subcutaneous administration, including self-injection by patients, Humira will be supplied in 1-mL prefilled syringes that deliver 40 mg of adalimumab in 0.8 mL of a clear, colorless, preservative-free sterile solution.

Jeffrey M. Leiden, president and chief operating officer of Abbott's pharmaceuticals group, said during a Jan. 2 conference call that the prefilled syringes were designed to be easy to use by patients suffering from rheumatoid arthritis.

The prefilled syringes for patients' use will be packaged in cartons that contain two trays, each holding a ready-to-use glass syringe with needle attached, and two alcohol wipes. For institutional use, the prefilled syringes will be packaged one to a carton with two alcohol wipes and will include a needle-protection device.

In addition to the ready-to-use syringes, adalimumab will be available in 2-mL glass vials containing 40 mg of drug in 0.9 mL of solution.

Regardless of the packaging, the product must be refrigerated at 2–8 degrees Centigrade.

The recommended dosage of adalimumab is 40 mg injected subcutaneously every two weeks. According to the labeling, the product can be administered alone or used with methotrexate, nonsteroidal antiinflammatory drugs, analgesics, and other DMARDs. Adalimumab can be administered at a dosage of 40 mg weekly in patients who are not also receiving methotrexate.

The labeling states that adalimumab, like other TNF blockers, is associated with serious and sometimes fatal infections, particularly among patients undergoing immunosuppressive therapy. Patients with an active infection should not use adalimumab, and the drug should be discontinued if an infection develops. The drug is not recommended for use in patients living in areas where tuberculosis and histoplasmosis are endemic.

Common but less serious adverse events associated with adalimumab use include redness, rash, itching, swelling, and bruising at the injection site.