Humira is approved to control ulcerative colitis when immunosuppressant medicines like corticosteroids, azathioprine, and 6-mercaptopurine have not worked. The drug is an anti-tumor necrosis factor (TNF) that blocks proteins that play an important role in abnormal inflammatory and immune responses.
Ulcerative colitis is a chronic disease that causes inflammation and ulcers in the inner lining of the large intestine. It is one of two main forms of chronic inflammatory bowel disease and affects about 620,000 Americans, according to the National Institutes of Health.
"Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual's needs," said Donna Griebel, M.D., director of the Division of Gastroenterology and Inborn Errors Products in FDA's Center for Drug Evaluation and Research. "Today's approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy."
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).
Patients with ulcerative colitis are normally evaluated for stool frequency, rectal bleeding, endoscopic findings and a physician's assessment, which combined provide a score ranging from 0 to 12 to help assess the activity of ulcerative colitis. This scoring system is commonly referred to as the Mayo score.
Humira's safety and effectiveness for 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 to TNF-blockers participated in the studies. All patients enrolled in the studies had a Mayo score of 6 to 12 and an endoscopy subscore of 2 to 3. Patients were randomly assigned to take Humira or a placebo.
The studies were designed to measure the percentage of patients whose Mayo score decreased to 2 or less with no individual subscore of more than 1 after eight weeks of treatment. Patients who obtained such reductions in the Mayo score were determined to have achieved clinical remission.
Results from both studies showed 16.5 percent to 18.5 percent of patients treated with Humira achieved clinical remission compared with 9.2 percent to 9.3 percent of patients receiving placebo. Additionally, in the second study, 8.5 percent of patients treated with Humira sustained clinical remission compared with 4.1 percent of patients treated with placebo. The effectiveness of Humira has not been established in patients with ulcerative colitis who have lost response to or were intolerant to TNF blockers.
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 should only continue to be used in patients who have shown evidence of clinical remission by eight weeks of therapy.
No new side effects were identified during clinical studies. Common side effects of Humira include infections, reactions at the injection site, headache, and rash.
Humira is manufactured by Abbott Laboratories, based in North Chicago, Ill.
The U.S. Food and Drug Administration today expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults.