Relief may soon be on the way for more than a million Americans who suffer from inflammatory bowel diseases and do not respond to or cannot tolerate the side effects of current medications.
Research out today by doctors at the University of California, San Diego shows that a new drug called vedolizumab works well for both ulcerative colitis and Crohn's disease, usually without severe side effects.
Doctors reported the results in two studies published in The New England Journal of Medicine. The ulcerative colitis research involved 895 patients in 34 countries. More than 1,100 Crohn's disease patients from 39 countries were also studied. The researchers followed subjects for one year.
“That the drug works in two diseases is a great thing,” said lead researcher Dr. William Sandborn in an interview with Healthline. “It's easier for doctors to get experience for the drug, and that knowledge and experience really translates into better patient care. You acquire the knowledge quicker, and I think that's exciting.”
Takeda Pharmaceuticals funded the research and filed for U.S. Food and Drug Administration approval of the drug in June.
Why This Medication Is Different
The mechanism of action for vedolizumab is different from other medications used to treat these illnesses. The new drug, known as a leukocyte traffic inhibitor, prevents white blood cells from gathering in the area of inflammation. It specifically targets the gut, leading to fewer infections than immunosupression drugs, which dampen the response of the entire immune system.
Those who suffer from inflammatory bowel diseases experience problems like diarrhea and a nagging urge to defecate. The conditions can lead to serious complications, such as intestinal bleeding, colon cancer, and bowel obstructions. Sometimes, a portion of the bowel needs to be removed to bring ulcerative colitis patients relief.
Some existing drugs used to treat ulcerative colitis do not work for Crohn's patients. Others cause a serious, often fatal brain disease called progressive multifocal leukoencephalitis (PML).
In both studies, about half of the subjects had failed other therapies, Sandborn said.
In many cases, study participants with ulcerative colitis experienced complete healing of the bowel.
However, five people in the Crohn's disease study died during the trial. One of them had a perforated colon and did not receive a life-saving surgery. The others had additional serious complications.
“The level of medical care varies around the world,” Sandborn said. “When a person gets an infection and dies, it's hard to say a drug that affects the immune system played no role at all. It's possible it did, but not there's not a strong link.”
Dr. David Rubin, co-director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, called the new studies “big news.” University of Chicago Medicine also participated in the research.
Dr. Rakesh Bhattacharjee, a colleague of Rubin's at the University of Chicago Medicine who practices in pediatrics, suffers from an inflammatory bowel disease himself.
He said he is a candidate for the new medication because he continues to have symptoms despite receiving medical care. He told Healthline the disease can be “quite debilitating,” adding that when you're not in the comfort of your own home, it increases the stress load and creates a vicious cycle.
“If you can prevent some invasive therapeutic strategies like surgery, you're going to make a lot of people thankful,” Bhattacharjee said.