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.