The National Registry of Patients with Inflammatory Bowel Disease (IBD) in the Russian Federation was established to study the epidemiological and clinical characteristics of patients and evaluate the actual clinical practice of medical and surgical treatment.AIM: to analyze the data of patients with IBD in the Russian Federation including clinical and demographic characteristics, medical status of patients, the frequency of use of various classes of drugs and response to treatment, the survival rates of advanced therapy drugs and the reasons for their cancellation.METHODS: from May 2017 to August 2021, depersonalized data of 3827 adult patients with IBD (ulcerative colitis (UC) – 2358 pts, Crohn's disease (CD) - 1469 pts) from 80 regions of the Russian Federation were included in the registry, both with previously and newly diagnosed UCor CD, who are in inpatient or outpatient care.RESULTS: in our population, the ratio of UC: CD was 1.6:1. The distribution of patients by sex was the same. The average age of patients in the registry was 40.6±13.1 (13-83 years) for UC and 38.5±14.3 (15-75 years) for CD, the half of patients were in the age range of 21-40 years for both diseases. The average age of disease onset did not differ for UC and CD and was 35.3 year (12-75 years) and 31.2 year (14-72 years) respectively. The duration between the onset of symptoms and the establishment of a diagnosis was 13.2 months in UC, and statistically significantly longer in CD - 34.8 months (P<0.01). The proportion of smokers in CD patients was statistically significantly higher than in UC ones (14.6% versus 9.6%, respectively, P<0.001). The incidence of disability was also significantly higher in CD than in UC patients (41.7% vs. 29.8%, P<0.01). The diagnosis of mild UC was established in 36% of cases, moderate UC occurred in 48.9% of patients, severe UC in 14.2% of patients. For the first time, the frequency of acute severe UC (1%) was estimated. The majority of patients had total UC (56.8%), 33% had left-side colitis, and 9.4% had proctitis. CD was divided by localization into ileocolitis 55.9%, terminal ileitis 23.9%, colitis 20.2%, perianal lesions were noted in 32.5% of cases. The overall complication rate in CD was 46% (681 patients), of which the most common were strictures - 48% and fistulas- 25.1%.Frequencyof extra intestinal manifestations did not differ in UC and CD patients and was 20.1% (473 patients) and 24.5% (360 patients), respectively. Of these, musculoskeletal lesions were more common (41.6% in UC, 42% in CD), lesions of the skin, eyes, mucous membranes, liver, anemia were also noted. In the treatment of IBD, steroids were used most often (79.3% and 65% in UC and CD, respectively), followed by 5-ASA - 47% in UC, 32.4% in CD. Immunosuppressant’s in CD were prescribed significantly more often (28.4%) than in UC (11%) (p<0.05). Biologics were used in 20.6% of UC patients and in 30% of CD patients. The highest 2-year survival of advanced therapy was noted for ustekinumab in CD (96%), for tofacitinib in UC (89.3%), and for vedolizumab in both UC and CD (92.5% and 88.4% respectively). The survival rates of all TNF-α inhibitors were approximately the same and varied within 58.1-72.4% in UC and 60-70% in CD. The most common reasons for discontinuation of advanced treatment were lack of efficacy/loss of response in both UC and CD. The second common reason was achieving remission. Certolizumab pegol in CD was canceled for this reason most often- 22.7% of cases. A small number of patients discontinued treatment due to adverse events: for UC - 1 patient each on adalimumab, golimumab, and tofacitinib, and 7 patients on infliximab, for CD- 5 patients on infliximab and adalimumab (9.6% and 7.5%, respectively) and 2 patients (4.6%) on certolizumab. Unfortunately, the proportion of discontinuation for non-medical reasons was significant and varied from 7% to 50% for different drugs. In some patients, the reason for discontinuation of therapy remained unknown.CONCLUSION: The difficulties of differential, often untimely diagnosis of CD and UC, the predominance of complicated and severe forms against the background of an increase in morbidity and prevalence, and at the same time the lack of adequate statistical accounting of CD and UC, make it necessary to create a unified clinical register of patients with IBD. The register of IBD patients will provide a holistic picture of the IBD situation in the country, including optimizing the use of budget funds for the treatment of patients with CD and UC, ensuring their rational planning.

Background. Inflammatory bowel diseases (IBD) are characterized by chronic immune inflammation of the mucous membrane and/or the thickness of the intestinal wall, and are also accompanied by disorders of the blood clotting system and the development of a hypercoagulation state. Aim. To identify the frequency of thromboembolic complications (TEC) in IBD patients and to determine the influence of acquired and inherited hypercoagulation factors that contribute to the development of TEС. Materials and methods. The clinical status of 1,238 IBD patients who were treated in 2019 was evaluated. Of these, 748 patients with ulcerative colitis (UC) and 490 patients with Crohn's disease (CD). Among UC patients, there were 369 (49.3%) men and 379 (50.7%) women. In 10.1% of patients with UC, there were clinically significant feasibility studies. There were 227 (46.3%) men and 263 (53.7%) women among patients with CD; 7.3% of patients with CD had clinically significant feasibility studies. Results. In general 112 (9.0%) of 1,238 IBD patients had clinically significant feasibility studies. Among patients with UC (n=748), 76 (10.2%) showed clinically significant feasibility studies. Among patients with CD (n=490), 36 (7.3%) had a feasibility study. Of 112 IBD patients with clinically significant TEC, 45 (40.2%) had genetic polymorphisms that increase affinity for fibrinogen, increase platelet aggregation, and contribute to a decrease in the activity of folate cycle enzymes, including methylenetetrahydrofolate reductase, which may be manifested by a moderate increase in homocysteine levels. Of the 45 IBD patients with clinically significant TEC due to inherited factors, 30 (66.6%) patients had UC, 15 (33.7%) patients had CD (hazard ratio 1.038, 95% confidence interval 0.7461.444; 2=0.049; p=0.83921); 67 (59.8%) patients with IBD who had clinically significant TEC did not have genetic polymorphisms leading to hypercoagulation. Conclusion. Based on the analysis, we can conclude that such risk factors for the development of TEC as the status of a smoker, long bed rest, taking hormonal contraceptives, varicose veins of the lower extremities, high activity of the disease, glucocorticoids therapy, the extent of intestinal damage in patients with IBD, genetic factors, should be taken into account by gastroenterologists in the treatment of patients with UC and CD. The hereditary factor of hypercoagulation equally affects the development of TEC, both in patients with UC and CD.

Real - life data on the effectiveness and safety of biosimilar and biologic drugs licensed for treatment of inflammatory bowel diseases (IBD) is lacking. Aim. To investigate efficacy of original Infliximab (IFX) and its biosimilar in treating patients with ulcerative colitis (UC) and determine the frequency of adverse events during 1 year follow - up period. Materials and methods. Our cohort consisted of 98 ulcerative colitis patients, treated with original IFX and its biosimilar since December 2017 till December 2018 years. Original Infliximab was prescribed in 56 UC patients (57.1%) during 5 years and longer; 16 patients (16.3%) were switched to IFX biosimilar; 13 UC bio - naïve patients (13.3%) received original IFX, 29 (29.6%) patients - biosimilar IFX. In 14 patients (14.3%) original infliximab was rotated with biosimilar. We picked out 42 patients to assess efficacy of original IFX and biosimilar. Results and discussion. Twelve patients, received original IFX and 28 patients, treated with its biosimilar, showed significant clinical improvement by decreasing Mayo index from 9.7±0.4 and 10.2±0.2 points to 1.9±0.09 and 2.1±0.1 points, accordingly. Also we noticed positive change in laboratory markers - CRP decrease from 89.6±8.7 mg/l and 77.5±8.0 mg/l to 6.5±0.8 mg/l and 6.9±0.8 mg/l (p>0.05), albumin increase from 30.1±4.7 g/l and 29.6±3.6 g/l to 34.1±6.3 g/l and 32.8±5.9 g/l (p>0.05), increase of serum iron levels from 6.4±0.5 mcg/l and 7.1±0.65 mcg/l to 14.6±4.4 mcg/l and 15.9±5.1 mcg/l (p>0.05), hemoglobin increase from 104.7±9.8 g/l and 102.2±8.8 g/l till 124±11.3 g/l and 121±10.9 g/l (p>0.05), and fecal calprotectin decrease from 1680±134 mcg/g and 1720±126 mcg/g till 245.5±33.4 mcg/g and 230.5±29.8 mcg/g (p>0.05). During 1 year follow - up 12 UC patients, treated with original IFX and its biosimilar, developed adverse events. The majority of adverse events (n=8) were registered in patients, rotating administration of original IFX and its biosimilar. Conclusion. IFX biosimilar is effective as well as original IFX. Frequency of adverse events, occurred in patients, treated with original IFX, was comparable with adverse events frequency in patients, received biosimilar IFX. Frequency of adverse events was significantly higher in UC patients, rotating original IFX and its biosimilar.

Current conception of deep remission in patients with ulcerative colitis (UC) consists of clinical remission, endoscopic mucosal healing and normalization of laboratory markers. Histological remission should not be used as a primary end point for therapeutic efficacy, but instead should be considered as a marker of deep remission. The main goal of UC treatment should be focused on endoscopic healing of colon mucosa, decrease of inflammation activity, prolonged remission, absence of disease recurrence, and also histologic remission. Nevertheless, the term histologic remission has not yet been fully validated and no histologic indexes have been standardized. We need single unified definition for remission, based on multicentral studies analysis. One of important challenge is restoration of normal colon mucosal and results of multiple studies showed contradictory tests for assessing histologic remission, thus remaining an issue for further discussion.

Aim. To conduct comparative analysis of histological remission in patients with moderate and severe ulcerative colitis (UC), receiving biological therapy vedolizumab, mesenchymal stem cell (MSC) treatment and combined stem cells and vedolizumab therapy. Materials and methods. We studied biopsies of 75 patients with total or left-sided moderate and severe ulcerative colitis, divided into groups depending on treatment. The first group of UC patients (n=29) received stem cell therapy 2 mln per kg; the second group of UC patients (n=27) received vedolizumab and the third group (n=19) MSC and vedolizumab. The efficacу of treatment was assessed by C reactive protein (CRP), Mayo score (MS), fecal calprotectin (FC) and Geboes score (GS). Results. We determined medium correlation between basic FC and MS before treatment (r=0.6605, p0.05). After 12 weeks of treatment in the first group of UC patients (n=29) CRP was 7.82.1 mg/l, FC 409.344.85 g/g, medium GS 1.20.1 points. After 12 weeks of treatment in the second group of UC patients (n=27) CRP was 8.41.4 mg/l, FC 435.547.3 g/g, medium GS 1.350.15 points. After 12 weeks of treatment in the third group of UC patients (n=19) CRP was 6.41.1 mg/l, FC 290.617.5 g/g, medium GS 0.90.1 points. We proved strong direct relationship between FC and GS after 12 weeks of treatment in UC patients, receiving MSC (r=0.8392, p0.05). The statistically significant majority of patients, achieved histological remission, have less than 5-year duration of disease. Conclusion. Our study showed that clinical and endoscopic remission in UC patients does not always correlate with histological remission. Combined anti-cytokine and stem cells therapy contributes to achieve deep remission and decrease mucosa inflammation rather than single MSC or vedolizumab treatment. Deep remission could be achieved by earlier start of biological therapy. FC could be a predictor and marker of mucosa healing and histological remission