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.
Crohn's disease (CD) is a chronic autoimmune disease of the gastrointestinal tract, which mainly affects young people of productive age. Until now, patients with this disease cannot be cured with by conservative therapy or surgery. The effectiveness of drugs for CD is limited, and their use is often accompanied by adverse events. All this creates a need for new drugs, fundamentally different in the action, with high efficiency and a good safety profile. The review is dedicated to a new biological agent for the treatment of CD blocking interleukins 12 and 23, which are involved in the pathogenesis of inflammation in inflammatory bowel diseases. This review presents the data of phases 2 and 3 clinical trials of the agent and the data obtained in real clinical practice, allowing to conclude about the efficacy and safety, as well as its place in the treatment algorithm for CD.
AIM: to evaluate the effectiveness of tofacitinib as a second line treatment.PATIENTS AND METHODS: the study included 12 patients, 4 (33.34%) males and 8 (66.66%) females. The median age was 41 ± 5 years. All patients admitted to the hospital with a severe flare-up of ulcerative colitis, which was the inclusion criterion in this study. Clinical manifestations, laboratory parameters, and colonoscopy were done at the time of administration of tofacitinib, on days 3 and 7, and after 12 weeks.RESULTS: a fast clinical response on 3 day of treatment, reduction in stool frequency, decrease blood in stool was noted in 10 (83.3%) patients. After 7 days from the start of TFCS therapy, all patients showed a decrease from severe activity to mild activity, as well as a decrease in inflammatory blood markers and hemoglobin levels. During the follow-up for 12 weeks, 100% of patients showed positive clinical and laboratory changes. In 10 (83.4%) patients, remission or maintenance of negligible minimal activity was noted.CONCLUSION: the results obtained show that the use of TFTB in hormone-resistant patients can be effective as a second line of “rescue therapy”.
The study is dedicated to one of the most discussed problems of the last decade, not only in gastroenterology, but also in the scientific world. The more knowledge and ideas we have about the composition and function of the microbiota of the human body, in particular the microflora of the gastrointestinal tract, as one of the most populated department by microorganisms of the human body, the better we realize that we are only at the beginning of the this way. The evolution of methods for diagnosing of microbiota from microbiological method to modern molecular genetic techniques to isolate the genetic material of bacteria, of course, plays a key role in our understanding of this issue, attempts to establish the role of microorganisms in the development of diseases of various human systems. Inflammatory bowel diseases, including ulcerative colitis, belong to pathological conditions with an unclear etiology characterized by a chronic severe course, a diverse clinical picture, difficulty in establishing a diagnosis, long-term treatment. In this research with the modern diagnostic methods an attempt is made to come closer to understanding the changes that occur in the intestinal microbiota with ulcerative colitis, identifying probable etiological and pathogenetic agents, and identifying possible targets for exposure as additional methods of treating the disease.
Background Patients with complicated Crohn’s disease are the most difficult cohort to make right decision in treatment and timing surgery. These patients are at risk for the long duration of operations, length of hospital stay, repeated urgent interventions because of complications and the need for a temporary stoma. In literature there is lack of information concerning the usage of prolonged antibiotics in such cases and results are conflicting in some studies. Single center non-randomized prospective study was held. Methods 120 patients were evaluated from 2012 to 2017. All patients had a complicated Crohn’s disease with abdominal mass, fistulas and stricture of the terminal ileum and all of them were operated on. In the first group there were 48 patients who received preoperative treatment with ciprofloxacin and metronidazole for at least 2.5 (1–4) months. In the second group patients also received the same treatment for the median time of 13 (1–33) days. Our hypothesis has been that prolonged treatment allows to reduce postoperative complications and the risk of stoma formation. To prove this statement, we did Chi-squared and Fisher’s exact test, univariant and multivariant analyses. The following criteria were included: prolonged treatment, gender, age, perianal lesion, laparoscopic operation, blood loss and duration of surgery. Results In the first group the complication rate was 4 (8.3%) and in 27 (56.2%) patients there was the need for stoma formation. In the second group – 18 (25%) and 58 (80.5%), respectively. First, we used Fisher’s test to see some correlations between the treatment and complications and the need of stoma formation. Prolonged treatment reduces the rate of complications in 4-fold (OR 0.25; x2= 5.34; p=0.02) and the need of stoma in 3-fold (OR 0.3; x2=8.24; p=0.004). In uni- and multivariant analyses prolonged treatment significantly reduces the complication rate and the risk for stoma creation (OR 2.73 CI 0.037–0.86; p= 0.02 and OR 0.310 CI 0.02–0.72 p=0.004, respectively). Gender, age, perianal lesion, laparoscopic operation, blood loss and duration of surgery were not statistically significant in multivariant analysis. Conclusion preoperative prolonged antibiotic treatment in complicated Crohn’s disease significantly reduced complications rate and the risk of stoma creation.
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