Scientists from 34 countries with an IKBFU researcher among them are working on a medicine for the treatment of ulcerative colitis.
IKBFU center for clinical research scientists have participated in the international VARSITY clinical research. It's the world's first research aimed at finding the most effective drug among anti-inflammatory ones for the treatment of ulcerative colitis. Ulcerative colitis (UC) is a long-term condition that results in inflammation and ulcers of the colon and rectum. The disease can cause severe complications, starting with fistula in neighboring internal organs with a risk of peritonitis and ending with malignant neoplasms. The research was carried out in 245 research centers of 34 countries (19 Russian centers were among them). There were 771 patients aged from 18 to 85 years, with moderate and severe forms of ulcerative colitis.
Prof. Vladimir Rafalskiy, director of the IKBFU center for clinical research said:
15 years ago our opportunities in treating ulcerative colitis were quite limited. Doctors only had to use hormones glucocorticoids, the drug azathioprine, and salicylic acid derivatives. There were only three groups of drugs and the effectiveness of those groups was far from what was expected by doctors and patients alike. But the pharmacological science moves on and about ten years ago a new type of drugs was created. This is an innovative bio-genetic drug, producing antibodies blocking inflammation molecules and allowing very effective control of ulcerative colitis.
Today's pharmaceutical market offers patients with ulcerative colitis five drugs from the group of inhibitors of tumor necrosis factor and one anti-integrin drug. These are effective in treating the disease, especially in comparison with earlier drugs. Interestingly, the new generation drugs have never been compared.
Prof. Rafalskiy said:
This is the first time when two new drugs are being compared. One of the drugs is an inhibitor of tumor necrosis factor and the other is an anti-integrin drug. The research was conducted from 2015 to 2019. The patients were randomly divided into two groups with different drugs (adalimumab and vedolizumab )administered to each group. There were several criteria for the research: clinical efficacy, the manifestation of the symptoms of the disease (participants filled in electronic diaries indicating the frequency of defecation, bleeding, abdominal pain, etc.), the results of colonoscopy before and after therapy, the results of histological examination, etc. The research has shown that vedolizumab is 9-12% more effective. And this difference is important for the treatment of ulcerative colitis.
Sands, B. E. et al. (2019) Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. The New England Journal of Medicine. doi.org/10.1056/NEJMoa1905725