A new intravenous antibody medication has shown positive results for treating both Crohn's disease and ulcerative colitis, scientists have found.
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.
"The two trials showed highly encouraging results for patients suffering from moderate-to-severe Crohn's disease and ulcerative colitis when conventional therapy such as steroids, immune suppressive drugs and anti-tumour necrosis factor (TNF) biologic drugs failed," said William Sandborn, principal investigator of the Crohn's disease study, from University of California - San Diego School of Medicine.
"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.
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.
The targeted nature of the medication helps reduce troublesome side effects such as weight gain, nausea and headaches caused by other treatment options.
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.
