The IKBFU center for clinical research scientists have participated in the international VARSITY clinical research study, the world's first study aimed at finding the most effective drug among anti-inflammatory drugs for the treatment of ulcerative colitis. The results, ‘Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis’, were published in The New England Journal of Medicine.
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 neighbouring internal organs, with a risk of peritonitis and ending with malignant neoplasms. The research was carried out in 245 research centres of 34 countries (19 Russian centres were among them). There were 771 patients aged from 18 to 85 years, with moderate and severe forms of ulcerative colitis.
“Fifteen 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,” explained Professor Vladimir Rafalskiy, director of the IKBFU center for clinical research. “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, there are several drugs for patients with ulcerative colitis five drugs from the group of inhibitors of tumour 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.
This is the first time that two new drugs are being compared - one of the drugs is an inhibitor of tumour 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.
At week 52, clinical remission was observed in a higher percentage of patients in the vedolizumab group than in the adalimumab group (31.3% vs. 22.5%; difference, 8.8 percentage points; p=0.006), as was endoscopic improvement (39.7% vs. 27.7%; difference, 11.9 percentage points; p<0.001). Corticosteroid-free clinical remission occurred in 12.6% of the patients in the vedolizumab group and in 21.8% in the adalimumab group (difference, −9.3 percentage points). Exposure-adjusted incidence rates of infection were 23.4 and 34.6 events per 100 patient-years with vedolizumab and adalimumab, respectively, and the corresponding rates for serious infection were 1.6 and 2.2 events per 100 patient-years.
“In this trial involving patients with moderately to severely active ulcerative colitis, vedolizumab was superior to adalimumab with respect to achievement of clinical remission and endoscopic improvement, but not corticosteroid-free clinical remission,” the paper concluded.