Humira (adalimumab), previously approved by the FDA to treat such diseases as rheumatoid arthritis (2002), psoriatic arthritis (2005), ankylosing spondylitis (2006), Crohn’s disease (2007), plaque psoriasis (2008) and juvenile idiopathic arthritis (2008), has now been expanded to include treatment of moderate-to-severe ulcerative colitis in adults, when 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.
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.
“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.”
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.
Results from both studies showed 16.5%-18.5% of the patients treated with Humira achieved clinical remission compared with alittle more than 9% for patients given a placebo. Additionally, in the second study, 8.5% of patients treated with Humira sustained clinical remission compared with 4.1% of those 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.
Common side effects of Humira include infections, reactions at the injection site, headache, and rash.
For more information speak with your doctor, or contact specialists at Yale-New haven Hospital, 20 York St., New Haven, CT 06510 203 688-4242.