The FDA ( Food and Drug Administration ) has approved Humira ( Adalimumab ) to treat adult patients with moderately to severely active Crohn's disease, a chronic inflammatory disease of the intestines, which affects an estimated one million Americans. Humira is a human-derived, genetically-engineered monoclonal antibody.
The product acts to reduce excessive levels of human tumor necrosis factor ( TNF ) alpha, which plays an important role in abnormal inflammatory and immune responses.
Crohn's disease is a chronic, incurable, inflammatory bowel disease that causes diarrhea, cramping and abdominal pain, and in some cases, fistulas.
Humira has been studied in 1,478 patients with Crohn's disease in four clinical trials comparing the drug to a placebo and two longer term extension studies.
The labeling of Humira includes a boxed warning, the strongest type of label warning, that use of this product has been associated with serious, sometimes fatal, infections, including cases of tuberculosis, opportunistic infections, and sepsis. Before initiating Humira treatment, patients should be evaluated for tuberculosis risk factors and tested for latent tuberculosis infection. Other serious adverse events reported by Humira users include lymphoma, a type of cancer. The most frequent adverse events included upper respiratory infections, sinusitis, and nausea.
Humira requires subcutaneous injections to initiate treatment for Crohn's disease, and maintenance treatment is administered as one injection every other week.
Humira was previously approved for the treatment of three autoimmune diseases: rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Source: FDA, 2007
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