AIM: to improve the results of treatment of patients with «extremely severe» ulcerative colitis (UC).

PATIENTS AND METHODS: A multicenter observational prospective «case-control» study was conducted. The study included 71 patients with «extremely» severe UC from June 2019 to October 2021. All patients underwent conservative therapy in accordance with current clinical guidelines. Evaluation of the effectiveness of treatment was carried out on the 3rd and 7th days of therapy, a "response" or "no response" to steroid therapy was stated.

RESULTS: A total of 48 (68%) patients underwent surgical treatment during the follow-up period during hospitalization. 23 (32%) patients "responded" to conservative therapy and were discharged without colectomy. A reliable independent predictor of colectomy at the time of hospitalization was the level of albumin less than 29 g/l (OR – 8,6 95% CI: 2,5 – 39,9, p=0,002). On day 3, the reliable predictors were the level of C-reactive protein over 15.5 mg/l (OR – 9 95% CI: 2.4 – 46.1, p=0.003) and the value of the Mayo index above 7 points (OR – 13.3 95% CI: 3.3 – 75.7, p=0.0009).

CONCLUSION: The study has demonstrated that the only reliable and independent predictor of colectomy at admission to the clinic is the level of albumin less than 29 g/l. Reliable factors that make it possible to evaluate and predict the effectiveness of therapy are the level of C-reactive protein more than 15.5 mg/l and the value of the Mayo index above 7 points on the 3rd day of therapy, as well as the level of C-reactive protein above 29 mg/l on the 7th day.

AIM: to evaluate efficacy and safety of ustekinumab in Russian patients with ulcerative colitis in UNIFI study. PATIENTS AND METHODS: the UNIFI program (CNTO1275UCO3001) consisted of two randomized placebo-controlled trials: an 8-week induction study and a 44-week maintenance study and long-term period. This analysis included patients from 14 Russian centers.

RESULTS: the induction study of the UNIFI program enrolled 74 patients from Russia, 89.2% patients (n = 66) were bionaive. The paper presents the results of bionaive patients. Sixty-six are included in the induction phase: 18 received ustekinumab 130 mg IV, 25 received ustekinumab 6 mg/kg IV, and 23 received a placebo. At week 8 in the groups of patients treated with ustekinumab at doses of 6 mg/kg and 130 mg, clinical remission was achieved in 24.0% and 16.7%, respectively, in the placebo group, the rate was 17.4%. The proportion of patients with clinical responses at week 8 was 68.0%, 50.0% and 39.1% in the ustekinumab 6 mg/kg, 130 mg and placebo groups, respectively. Mucosal healing at week 8 was achieved in 48.0% in the ustekinumab 6 mg/kg group, in 33.3% of patients in the ustekinumab 130 mg group, and in 21.7% of patients in the placebo group. Histoendoscopic mucosal healing at week 8 developed in 27.8% of patients in the ustekinumab 130 mg group, in 24.0% of patients in the ustekinumab 6 mg/kg group, and in 21.7% of patients in the placebo group. Forty bionaive patients were re-randomized for further participation in the maintenance phase: 13 patients received ustekinumab 90 mg subcutaneously every 12 weeks, 12 received ustekinumab every 8 weeks, and 15 received a placebo. At week 44, clinical remission was achieved in 46.2% of ustekinumab every 12 weeks, 75.0% of ustekinumab every 8 weeks (p = 0.054 compared with placebo), and 33.3% of placebo. Mucosal healing achieved in 46.2% of patients in the ustekinumab once every 12 weeks group, in 75.0% of patients in the ustekinumab once every 8 weeks group (p = 0.054 compared with. placebo), and in 33.3% of patients in the placebo group. Histoendoscopic mucosal healing achieved in 46.2% of patients in the ustekinumab once every 12 weeks group, while in the ustekinumab once every 8 weeks group, the percentage of such patients was 75.0% (p = 0.021 compared with placebo) and in the placebo group — 26.7%. Symptomatic remission at week 152 developed in 83.3% in the ustekinumab every 12 weeks group, 81.8% in the ustekinumab every 8 weeks group. In the induction phase decrease of CRP and FCP median levels detected in patients treated with ustekinumab, in the maintenance phase, median levels of laboratory inflammatory markers after induction were sustained by ustekinumab treatment. The rate of steroid-free symptomatic remission at week 152 was consistent with the rate of symptomatic remission. The safety profile of ustekinumab was generally consistent with placebo during all follow up period.

CONCLUSION: subanalysis confirmed shortand long-term efficacy and safety in Russian patients with moderate to severe active ulcerative colitis. The results of subanalysis are consistent with previously obtained data in the population of patients participating in the global UNIFI program.

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.

AIM: to evaluate the effect of intestinal anastomosis type on risk of Crohn’s disease (CD) recurrence.

PATIENTS AND METHODS: the retrospective cohort study included 130 patients with CD who underwent surgery for a complicated CD in 2012–2017. Ileocecal resection with anastomosis was performed in 112/130 (86.2%) patients. Resection of the terminal ileum with resection of the right side of the colon with the formation of an ileo-transverse anastomosis. In 18/130 (13.2%) cases. Stapled “side-to-side” anastomosis was formed in 57/130 (43.8%) patients, while hand sewn “end-to-end” — in 73/130 (56.2%) patients. Post-op complications occurred in 21/130 (16.2%) cases. After surgery, most patients were treated by azathioprine as an anti-recurrence therapy — 112/130 (86.2%) patients, while in 31/112 (23.8%) cases, additional biological therapy was done. In 14/130 (10.7%) patients, anti-recurrence therapy was carried out in mono mode with a biological drug.

RESULTS: mean follow-up was 28.5 (1.9–95.4) months. Recurrence occurred in 54/130 (41.5%) patients on average 18 ± 5 (12–41) months after surgery. Thus, the operative time exceeding 200 minutes was significantly associated with an increase in the recurrence rate (p = 0.03). It was found that the type of anastomosis does not affect the recurrence risk. Moreover, among the significant factors was the operative time. It increases the chance of recurrence by 2.9 times in the univariate model (p < 0.05), and in the multivariate model — by 6.3 times, when exceeding 155 minutes.

CONCLUSION: the type of anastomosis does not affect the recurrence risk. The operation time exceeding 155 minutes increases the chance of recurrence by 6 times (p < 0.01).

AIM: to distinguish clinical and laboratory markers that could help to diagnose irritable bowel syndrome (IBS) and forms of inflammatory bowel diseases (IBD) — Crohn`s disease (CD) and ulcerative colitis (UC), before colonoscopy.

PATIENTS AND METHODS: the retrospective study included 712 patients (CD — 39.2%, UC — 37.8%, IBS — 23%). Clinical (complaints, anamnesis) and laboratory data from medical histories of patients with confirmed flare of IBD and IBS analyzed.

RESULTS: Patients with IBS had significant direct correlations with female gender, constipation, abdominal pain, presence of concomitant functional pathology, absence of extra-intestinal (EIM) and perianal (PAM) manifestations, weight loss due to food restriction (р < 0.001), hemoglobin (р < 0.001) and total protein levels (р = 0.002), and inverse correlations with levels of leukocytes, fecal calprotectin (FC) and C-reactive protein (CRP) (p < 0.0001). Patients with IBD had significant direct correlations with night symptoms (р = 0.045 for CD, р = 0.023 for UC) and diarrhea (up to 2 times per 24 hours in CD, р = 0.018; ≥ 5 times per 24 hours in UC, р < 0.001) and FC (р < 0.001). CD was categorized by the presence of PAMs and EIMs, young age, fever, surgery in anamnesis (p < 0.001), weight loss (p = 0.032), elevated CRP levels, anemia (p < 0.001) and hypoproteinemia (р = 0.032). Patients with UC had direct correlations with male gender (р = 0.008), stool with blood and leukocytosis (р < 0.001) and had inverse correlation with abdominal pain (p < 0.001).

CONCLUSION: the identified clinical and laboratory markers can be used as criteria to distinguish IBD from IBS in routine clinical practice. However, further prospective studies are required for validation.

AIM: detection of steroid dependence and steroid resistance predictors in patients with ulcerative colitis (UC).

PATIENTS AND METHODS: a retrospective study was conducted. The medical documentation of 1105 patients, who underwent inpatient treatment in Ryzhikh National Medical Research Center of Coloproctology from 2018 to 2021, were analyzed. 69% of patients (n=762) received systemic steroid therapy for UC. In accordance with inclusion and non-inclusion criteria, the medical documentation of 170 patients was selected for statistical analysis. Depending on the steroid status of patients, three groups were identified: group 1 (n=56) with steroid dependence, group 2 (n=56) with steroid resistance and group 3 - control (n=58), who were prescribed systemic GCS without the further development of steroid dependence and resistance.

RESULTS: the incidence of steroid dependence was 23.4% (n=259), and steroid resistance was 15.2% (n=168). We identified the following predictors and risk factors of steroid dependence: age of the disease onset <30 y.o. (AOR=0,960, 95%CI= 0,928-0,993, p=0,019), start dose of prednisolone <60 mg (AOR=2,369, 95%ДИ= 1,030-5,441, p=0,042), prescription of systemic GCS ≥2 courses per year (AOR=2,988, 95%ДИ= 1,349-6,619, p=0,007), Mayo Index Score <10 (AOR=0,631, 95%ДИ=0,492-0,809, p<0,001). The risk of steroid resistance statistically significant when Mayo Index Score ≥10 (AOR=2,573, 95%ДИ=1,094-6,050, p=0,030), albumin level <37,1 g/l (AOR=4,571, 95%ДИ=1,567-13,330, p=0,005), CRP ≥47,1 mg/l (AOR=2,641, 95%ДИ=1,102-6,328, p=0,029).

CONCLUSION: it is rational to predict an individual response to GCS in patients with UC. With a high risk of developing steroid dependence and steroid resistance, it is advisable to consider early appointment of biological and target therapy, avoiding represcription of GCS.

AIM: to study sociodemographic, clinical and epidemiological features in patients with ulcerative colitis in the Irkutsk region (Russia).

PATIENTS AND METHODS: the database of the Irkutsk IBD Center included 1,122 patients with ulcerative colitis (UC) registered from 01.01.2006 to 31.12.2019. The study is retrospective with a focus on the results of follow-up, check up and treatment in different periods of their disease (acute attack, chronic course, remission). Statistical analysis was performed according to the principles of the International Committee of Medical Journal Editors (ICMJE).

RESULTS: the incidence of inflammatory bowel disease in the Irkutsk Oblast over the previous 14 years has increased by 2.7 times, of ulcerative colitis — by 3.1 times and was 3.91 person-years per 100,000 population. The prevalence of UC was 68.5 per 100,000 population. The annual increase in new UC cases was 46.6 ± 8.2. Most patients had total lesion (68.4%) and moderate-to-severe disease (46.9%). Extra-intestinal manifestations (13.6%) were represented by skin lesions (40.7%). Body weight deficiency occurred in 9.9% in females and in 5.1% in males. The probability of colectomy was 1.4/100 patient-years (follow-up period was 7049.5 patient-years; n = 1122). Patients underwent urgent operations in 76.3%. Postoperative mortality was 1.03/100 patient-years (exposition time — 291.6 years, n = 3). Total mortality for the entire follow-up period was 1.8% — 0.34/100 patient-years (exposition time — 4440.8 years).

CONCLUSION: objective epidemiological data, clinical features and treatment options for patients with ulcerative colitis in long-term follow-up in the Irkutsk Oblast are presented. The results of such studies on a national scale can serve as a platform for further scientific research and planning of socio-economic programs.

Diagnosis of extrapulmonary forms of tuberculosis is still challenging. Abdominal tuberculosis has no pathogno- monic signs, so most patients had various diagnoses. In this clinical case, the diagnostic difficulties are due to the absence of a history of tuberculosis and the manifestation of the isolated tuberculosis process in the intestine. This forced us for a wide differential diagnostic search to exclude inflammatory bowel diseases and neoplasms and required the multidisciplinary team. This approach, awareness and alertness of specialists regarding extrapulmonary forms of tuberculosis made it possible to achieve success in this patient.

Treatment of аnal fistulas as perianal manifestations of Crohn’s disease is an important task, the solution of which has not yet been found. First of all, this is due to debilitating symptoms that reduce the quality of life. Incorrect tactics in the treatment of this disease can lead to the development of anal incontinence, and in some cases to the removal of the rectum. The purpose of this review was to study the effectiveness of various surgical methods for the treatment of perianal fistulas, the features of their use in various types of fistulas, as well as to assess the impact of surgical treatment on the function of the anal sphincter. It was found that most of the described methods were used in a strictly selected limited group of patients and allowed only temporary elimination of the clinical manifestations of Crohn’s disease. Unsatisfactory results of treatment, especially in the late postoperative period, a small number of clinical observations in published scientific papers on the treatment of perianal manifestations of Crohn’s disease, as well as low reliability of the results, dictate the need for further studies involving more patients.

Ulcerative colitis (UC) is an inflammatory bowel disease that mainly affects young people. Colorectal cancer (CRC) is one of the UC complications. This review considers the epidemiology, risk factors, diagnosis and screening, and drug prevention of CRC in UC. Various treatment options for dysplasia and CRC associated with UC are described. Taking into account the lack of literature to standardize colorectal cancer treatment approaches (especially rectal cancer) for UC, further studies are warranted to evaluate both oncological and functional treatment outcomes.

The incidence of ulcerative colitis (UC) and Crohn’s disease (CD) worldwide falls on the childbearing age. High activity of inflammatory bowel diseases (IBD) during pregnancy is a risk factor for the development of obstetric complications, and therefore it is necessary to control the course of diseases. Due to the lack of safety information, drug therapy is often unreasonably canceled during pregnancy. The publication provides up-to-date on the safety of basic and targeted therapy of UC and CD in pregnant.