According to findings published in the United States, a new treatment involving an investigational antibody could offer relief in treating the patients who suffer from inflammatory bowel diseases Crohn’s disease and ulcerative colitis.

An intravenous antibody medication Vedolizumab has been found to be effective in offering treatment to four million people who suffer from ulcerative colitis (UC) and Crohn’s disease (CD) and may be a solution to the problems of many have resort to other treatments as well without any positive cure, say researchers led by Western University’s Dr. Brian Feagan during the International GEMINI studies.

“This was really an important finding for patients who are failing these medications and are suffering from inflammatory bowel disease, It’ll give them another option”, said Brian Feagan. The researchers underwent two clinical trials, the results of which were published in the New England Journal of Medicine on Wednesday.

This new treatment sure offers new hopes to several million people who have been suffering from these auto-immune diseases. This also will show a new ray of hope to all the Canadians suffering from UC and CD, which has the highest rates of IBD in the world.

Crohn’s Study details led by Willaim Sandborn:
William Sandborn of the UC San Diego School of Medicine, who led the Crohn’s study said, “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” while the other drugs failed.

“These latest findings will potentially lead to a new drug therapy that will improve a patient’s overall lifestyle,” Sandborn said.

Study details led by Dr. Brian Feagan:
Dr. Brian Feagan discusses the course of treatment which offers hope to patients suffering from the most common forms of inflammatory bowel diseases, the Crohn’s disease (CD) and the ulcerative Colitis (UC), the symptoms of which include fatigue, weight loss, anaemia, diarrhoea and bleeding.

Due to a protein found in certain white blood cells which have the capability to leave the blood stream and enter the intestine causing inflammation, the intravenous antibody medication Vedolizumab was instilled to react with the protein which prevents the white blood cells to leave the blood stream, thus avoiding the inflammation and help in the cure of the diseases, said Dr. Richard Fedorak of University of Alberta.

Trial procedures:
The trial procedure involved 2,700 patients from 40 different countries who were given the treatment of the intravenous drip once a month.

The study by the researchers found that the patients who were treated with the new intravenous antibody medication had better results than any other drug they’d have tried in the past like placebos.

However the study also found that this new drug was slightly more effective in treating patients suffering from UC than CD.

Findings of the study:
During the 2 trial procedures led by the researchers, the following findings were published in the New England Journal of Medicine:

1. The new drug treatment showed 47% patients undergoing treatment for UC showing clinical response in 6 weeks compared to 26% who received placebo to treat UC.

2. 42-45% of the UC patients who continued the treatment of the new drug
were in remission 52 weeks into their treatment in comparison to the 16% of the patients who switched to placebo.

3. The new drug treatment showed 31% patients undergoing treatment for CD showing clinical response in 6 weeks compared to 22% who received placebo to treat CD. The drug is less effective for treating CD.

4. 26-39% of the CD patients who continued the treatment of the new drug
were in remission 52 weeks into their treatment in comparison to the 22% of the CD patients who switched to placebo.

According to Fedorak, other outcomes measured during the trials included blood tests, overall quality of life, endoscopy results and how the patient felt overall. He said, “In all of those factors, how they felt, quality of life, endoscopy… there was an improvement in every one of those sectors”.

Dr. Brian Feagan said that the new treatment involving the intravenous drug Vedolizumab shows definite promise over the other older treatments in the past, however these broad spectrum drugs come along various side effects like
pneumonia, skin infections or blood infections.

In comparison to the older drugs, the new drug could have fewer side effects as it targets the intestine. He also added saying, “We hope that ultimately these drugs will prove to be safer”.

Patient diagnosed with Crohn’s disease in 1974:
Len Fitch, 68 had been diagnosed with Crohn’s Disease in 1974. For years he had suffered from several symptoms of the disease including headaches, weight loss and abdominal pain. As part of the treatment to give him relief, the doctor removed 4 sections of his colon.

Fitch had tried the other treatments with no permanent long term solution to his disease, however since the time he has started using the Vedolizumab, intravenous antibody medication 14 months ago he has regained his health.

“It worked immediately for me, I feel normal and have since the day I took it, 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.

The treatment has been approved to be used in Canada for patients who have been tried with several other therapies in the past with no positive outcome.

Takeda Pharmaceutical Company Ltd., funded the trial and also applied to the
U.S. Food and Drug Administration and its European drug regulators, the European Medicines Agency, to have the antibody medication drug, vedolizumab approved for treatment.

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