Chronic and debilitating diseases, Crohn's disease (CD) and ulcerative colitis (UC) are the two most common forms of inflammatory bowel disease and affect more than four million people worldwide. Symptoms may include bleeding, diarrhea, fatigue, weight loss and anemia.
In two new studies, scientists showed that the use of investigational antibody vedolizumab resulted in remission and discontinued use of prednisone, a common yet difficult to tolerate drug used to treat both diseases.
A total of 895 patients were part of the ulcerative colitis trial conducted in 34 countries, and 1,115 patients were part of the Crohn's disease clinical trial conducted in 39 countries.
"This is a disease modifying drug. In many cases of patients with ulcerative colitis, complete healing of the bowel was observed and maintained with continued use of vedolizumab," he said.
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Vedolizumab is targeted to disease within the digestive tract so other areas of the body remain unaffected. It blocks immune system cells that release proteins called cytokines that trigger inflammation, causing tissue damage and diarrhea to move into the small intestine and colon.
Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan, funded the trial and has applied to the US Food and Drug Administration and the European Medicines Agency to have vedolizumab licensed for the treatment of adults with moderately to severely active CD and UC.
The results of the trials were published in the New England Journal of Medicine.