A new investigational antibody is an effective treatment for patients who suffer from the inflammatory bowel diseases Crohn’s disease and colitis when other treatments fail, a study has found.
The international GEMINI studies, led by Western University’s Dr. Brian Feagan, found that the antibody vedolizumab is effective for patients with ulcerative colitis (UC) and Crohn’s disease (CD), and may be a viable treatment for patients whose current treatments are not working.
“This was really an important finding for patients who are failing these medications and are suffering from inflammatory bowel disease,” Feagan told CTV News. “It’ll give them another option.”
UC and CD are two of the most common forms of inflammatory bowel disease, affecting more than four million people around the world. Symptoms of the diseases can include bleeding, diarrhea, fatigue, weight loss and anemia. Canada has one of the highest rates of IBD in the world.
Vedolizumab was engineered to react with a protein found in certain white blood cells, which can leave the blood stream and enter the intestine causing inflammation, University of Alberta’s Dr. Richard Fedorak told CTV News.
When vedolizumab reacts with this protein, it prevents the white blood cell from leaving the blood stream, thereby preventing inflammation, he said.
During the trial, which involved 2,700 patients from 40 different countries, the drug was administered once a month via intravenous drip.
It found that patients with UC and CD who were treated with the new drug had better outcomes than those who were treated with placebos, although the drug was slightly more effective in patients with UC.
The two studies were published in the New England Journal of Medicine Wednesday. They found:
- 47 per cent of UC patients receiving the drug showed a clinical response six weeks into their treatment, compared to 26 per cent of UC patients who received placebo.
- 42 to 45 per cent of those UC patients who continued to receive the drug were in remission 52 weeks into their treatment, compared to 16 per cent of UC patients who switched to placebo.
- The drug was less effective in patients with CD, with 31 per cent of patients receiving the drug showing a response rate six weeks into treatment versus 22 per cent for CD patients who received placebo.
- 26 to 39 per cent of CD patients who continued to receive the drug maintained remission 52 weeks into treatment, compared to 22 per cent of CD patients receiving placebo.
Other outcomes measured included how well patients felt, endoscopy results (to see if the intestine was healing), blood tests and overall quality of life, Fedorak said.
“In all of those factors, how they felt, quality of life, endoscopy… there was an improvement in every one of those sectors,” Fedorak said.
Feagan said that vedolizumab shows promise over older treatments, which are “broad spectrum” drugs and carry a wide array of side effects including pneumonia, skin infections or blood infections. By comparison, this new antibody selectively targets the intestine and could therefore cause fewer side effects, he said.
“We hope that ultimately these drugs will prove to be safer,” he said.
Patient Len Fitch, 68, was diagnosed with Crohn’s Disease in 1974. He told CTV News that he suffered for years from headaches, weight loss and abdominal pain, and spent time in the hospital as a result of the disease.
Doctors ultimately removed four sections of his colon to ease his suffering.
Other treatments he’s tried worked temporarily, but provided no long-term solutions, he said. But since starting Vedolizumab 14 months ago, Fitch said he’s regained much of his health.
“It worked immediately for me, I feel normal and have since the day I took it,” he said. “It is an infusion that takes one hour of my life once a month and I feel wonderful. The beauty of it is there are no side effects.”
He said that since recovering, he’s been keeping busy working on his farm and riding his motorcycle. “I’m back, I’m energetic. I don’t have anything to stop me out there,” he said.
Fedorak said the treatment may be approved for use in Canada for patients who can’t be treated with current therapies within one to two years.
Takeda Pharmaceutical Company Ltd., has applied to the U.S. Food and Drug Administration and its European counterpart, the European Medicines Agency, to have vedolizumab approved for treatment.