Humira reported to help ulcerative colitis patients not responsive to other treatments
Approximately 620,000 individuals in the United States suffer from ulcerative colitis, an inflammatory disease of the large intestine. A newly-approved medication may benefit people with moderate to severe ulcerative colitis who have not responded to corticosteroids and other immunosuppressant medicines.
On September 28, the Food and Drug Administration (FDA) announced that it had expanded the approved use of Humira (adalimumab) to include treatment of the condition in in adults. The drug is an anti-tumor necrosis factor (TNF) that blocks proteins, which play an important role in abnormal inflammatory and immune responses. The FDA notes that it should be used in individuals who have not been helped by immunosuppressant medicines such as corticosteroids, azathioprine, and 6-mercaptopurine have not worked.
Ulcerative colitis is a chronic disease that causes inflammation and ulcers in the inner lining of the large intestine. Ulcerative colitis and Crohn’s disease are the two major forms of chronic inflammatory bowel disease.
“Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual’s needs,” explained Donna Griebel, MD, director of the Division of Gastroenterology and Inborn Errors Products in FDA’s Center for Drug Evaluation and Research. She added, “Today’s approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy.”
Humira is manufactured by Abbott Laboratories, based in North Chicago, Illinois.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). To aid in the assessment of the condition, people 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. This scoring system is commonly referred to as the Mayo score.