Clinical and Demographic Features and Treatment Approaches for Inflammatory Bowel Diseases (Crohn’s Disease, Ulcerative Colitis) in the Russia. The Primery Results of the Analysis of the National Register

Abstract

The National Register of Patients with Inflammatory Bowel Disease (IBD) in the Russian Federation (RF) was established to study the epidemiological and clinical features and to evaluate the common conservative and surgical practice. AIM: to analyze the database of patients with IBD in the Russia including clinical and demographic features, medical status, the incidence of use of various classes of drugs and response to treatment, the survival rates of advanced therapy and the reasons for their cancellation. METHODS: from May 2017 to August 2021, depersonalized data of 3,827 adult patients with IBD (ulcerative colitis (UC) — 2,358 pts, Crohn’s disease (CD) — 1,469 pts) from 80 regions of the Russia were included in the register, both with previously and newly diagnosed UC or CD, who are in inpatient or outpatient care. RESULTS: in Russian population, the ratio of UC:CD was 1.6:1. The distribution of patients by gender was the same. The average age of patients in the register 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 years (12–75 years) and 31.2 years (14–72 years), respectively. The duration between the onset of symptoms and the establishment of a diagnosis was 13.2 months in UC, and significantly longer in CD — 34.8 months (P < 0.01). The proportion of smokers in CD was significantly higher than in UC (14.6% vs. 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 incidence of acute severe UC (1%) was estimated. The majority of patients had total UC (56.8%), 33.0 had left-sided colitis, and 9.4% had proctitis. In CD ileocolitisoccurred in 55.9%, terminal ileitis — in 23.9%, colitis — in 20.2%, perianal lesions — in 32.5% of cases. The morbidity rate in CD was 46% (681 patients), the most common were strictures (48.0%) and fistulas (25.1%). The rate of extraintestinal manifestations did not differ in UC and CD 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), fol-lowed by 5-ASA — 47% in UC, 32.4% in CD. Immunosuppressors in CD were prescribed significantly more often (28.4%) than in UC (11%) (p < 0.05). GEBDs (biotherapy) 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%), tofacitinib in UC (89.3%), and 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 cancel 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%). A small number of cancelled 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 cancel for non-medical reasons was significant and varied from 7% to 50% for different agents. In some patients, the reason for therapy cancel 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 incidence 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 for patients with IBD. The register of IBD patients will provide a holistic picture of the IBD situation in the country, including optimizing the budget funds for the treatment of patients with CD and UC, ensuring their rational planning.