Abbott has announced that a Phase III study has shown its rheumatoid arthritis drug Humira (adalimumab) to be effective in treating ulcerative colitis, which causes inflammation and ulceration in the lining of the colon or large intestine.
The study included 494 adult patients with ulcerative colitis, of which 248 patients were treated with Humira. It found that 17.3% of patients taking Humira achieved clinical remission after 52 weeks, compared to 8.5% on the placebo.
Symptoms of ulcerative colitis include abdominal cramping, rectal bleeding, more frequent bowel movements and diarrhoea.
The adverse affects seen with the use of Humira include injection site reactions, upper respiratory infections, headaches, rashes and nausea.
Abbott has submitted applications to both the US Food and Drug Administration and the European Medicines Agency seeking approval to market Humira for the treatment of moderate-to-severe ulcerative colitis.
