Abbott’s Humira receives FDA approval to treat ulcerative colitis
Illinois pharmaceutical, medical device and diagnostics company , Abbott announced Friday that the U.S. Food and Drug Administration (FDA) expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults.
Image/Abbott Media Library
Humira is the first and only self-administered biologic treatment approved for ulcerative colitis.
Ulcerative colitis is the seventh approved indication of Humira in the United States. 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 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.
As far as the drug’s safety and effectiveness, the FDA says it was 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.
According to William J. Sanborn, MD, Chief of Gastroenterology at UC-San Diego, ‘There is a significant unmet medical need in this patient population, which has not seen a new treatment approved in more than seven years.”
Humira is now approved to treat the two primary diseases that make up inflammatory bowel disease (IBD); ulcerative colitis and Crohn’s disease.
