Rx: Humira Approved for Ulcerative Colitis Treatment

[zumone2002]

http://www.medicinenet.com/script/main/art.asp?articlekey=163479

Humira Approved for Ulcerative Colitis Treatment

By Daniel J. DeNoon
WebMD Health News
Reviewed by Louise Chang, MD

Sept. 28, 2012 -- The FDA has approved Abbott's Humira for the
treatment of moderate to severe ulcerative colitis.

Humira (adalimumab) now is approved for both forms of inflammatory
bowel disease (IBD): ulcerative colitis and Crohn's disease.

It was already approved to treat Crohn's disease, rheumatoid
arthritis, psoriatic arthritis, plaque psoriasis, juvenile idiopathic
arthritis, and ankylosing spondylitis.

For ulcerative colitis, Humira is approved when other drugs to
suppress immune responses haven't worked.

"Each patient with ulcerative colitis experiences the disease
differently, and treatment must be adjusted to meet each individual's
needs," says Donna Griebel, MD, director of the FDA's gastroenterology
division. "Today's approval provides an important new treatment option
for patients who have had an inadequate response to conventional
therapy."

Clinical studies tested Humira in treating ulcerative colitis patients
with moderate to very severe disease. Clinical remission -- defined as
relatively mild disease -- happened after eight weeks of Humira
treatment in 16.5% to 18.5% of patients, compared to 9.2% to 9.3% of
patients given an inactive placebo.

The FDA-approved dosing regimen for Humira for ulcerative colitis
begins with an initial dose of 160 milligrams, a second dose two weeks
later of 80 mg, and a maintenance dose of 40 mg every other week,
thereafter. The drug is given by injection.

Ulcerative colitis patients who do not get clinical remission after
eight weeks of treatment should stop taking Humira.

Common side effects of Humira include infections, reactions at the
injection site, headache, and rash.

SOURCE:News release, FDA.

--
Luke