The U.S. Food and Drug Administration today expanded the approved use of Humira
(adalimumab) to include treatment of moderate-to-severe ulcerative colitis
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.