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FDA Okays Expanded Use of Humira (Adalimumab) in Ulcerative Colitis

TNF blocker indicated when immunosuppressants fail (Sept. 28)

On September 28, the FDA expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults.

Humira is approved to control ulcerative colitis when immunosuppressant medicines such as corticosteroids, azathioprine, and 6-mercaptopurine have failed. The drug is an anti-tumor necrosis factor (anti-TNF) antibody that blocks proteins that play an important role in abnormal inflammatory and immune responses.

The FDA previously approved Humira to treat rheumatoid arthritis (2002), psoriatic arthritis (2005), ankylosing spondylitis (2006), Crohn’s disease (2007), plaque psoriasis (2008), and juvenile idiopathic arthritis (2008).

Humira’s safety and effectiveness in patients with ulcerative colitis were established in two clinical studies. A total of 908 patients who had never been treated with a TNF blocker, or who lost response to or were intolerant of TNF blockers, participated in the studies. The patients were randomly assigned to receive Humira or placebo.

Patients with ulcerative colitis are normally evaluated for stool frequency, rectal bleeding, endoscopic findings, and a physician’s assessment, which, when combined, provide a score ranging from 0 to 12 to help assess disease activity. This scoring system is commonly referred to as the Mayo score.

The two clinical studies of Humira were designed to measure the percentage of patients whose Mayo scores decreased to 2 or less with no individual subscore of more than 1 after 8 weeks of treatment. Patients who obtained such reductions in the Mayo score were determined to have achieved clinical remission.

Results from both studies showed that 16.5% to 18.5% of patients treated with Humira achieved clinical remission compared with 9.2% to 9.3% of patients given placebo. In addition, in the second study, 8.5% of patients treated with Humira sustained clinical remission compared with 4.1% of placebo-treated patients. The effectiveness of Humira has not been established in patients with ulcerative colitis who have lost response to or are intolerant of TNF blockers.

The FDA-approved dosing regimen for Humira for ulcerative colitis begins with an initial dose of 160 mg, followed by a second 80-mg dose 2 weeks later and a maintenance dose of 40 mg every other week thereafter. Drug treatment should be continued only in patients who have shown evidence of clinical remission by 8 weeks of therapy.

Common side effects of Humira therapy include infections, injection-site reactions, headache, and rash.

Humira is manufactured by Abbott Laboratories, based in North Chicago, Ill.

For more information, visit the FDA Web site.

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