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.
AIM: to analyze basic medical care characteristics for hemorrhoidal disease (HD) in federal subjects of Russia in 2018.MATERIALS AND METHODS: the study is based on the summary data of the annual statistical observation form «Report of the chief coloproctologist of the subject of the Russian Federation» for 2018, which includes the level of outpatient treatment for HD per 100,000 of the population, the number of outpatient coloproctologists, the number of hospitalized patients for HD, the rate of patients hospitalized for emergency indications and number of coloproctological beds.RESULTS: in 2018 in Russia there were 304.9 outpatient visits per 100,000 thousand of the population for HD (Me=304.9; Q1=236.1; Q3=401.2). Number of coloproctologists was 0.23 per 100,000 (Me=0.23; Q1=0.13; Q3=0.32), and no correlation between these indicators was found (r=0.18; p=0.09). The hospitalization rate for HD was 36.8 (Me=36.8; Q1=30.5; Q3=44.7). There were 2.68 coloproctological beds per 100,000 (Me=2.68; Q1=1.95; Q3=3.35), and the percentage of patients with HD hospitalized in an emergency hospital was 34.0% (Me=34.0; Q1=24.0; Q3=45.0). There was no correlation between the number of patients treated in a hospital and the proportion of emergency hospitalizations in patients with hemorrhoids (r=0.1; p=0.38).CONCLUSION: in 2018, at least half a million patients with HD have got an outpatient consultation of coloproctologist. A significant staff shortage in specialists remains, and unresolved organizational problems require further studies.
Background Currently, there are differences in the results of international studies and treatment outcomes in patients with inflammatory bowel disease (IBD) and COVID-19. Further research is needed to help answer the questions: do IBD patients have an increased risk of contracting SARS-CoV-2? Do IBD patients have more severe COVID-19 outcomes? Does IBD therapy increase the risk of infection? Do any IBD treatments protect against COVID-19? Objective To study the effect of immunosuppressors, genetically engineered biologics, and janus kinase blockers on the level of SARS-CoV-2 class G immunoglobulins in IBD patients who underwent COVID-19. . Methods The level of SARS-CoV-2 class G immunoglobulins was analyzed in 66 patients with IBD after COVID-19 infection. Male 28 (42.4%) of women 38 (57.6 per cent). The median age was 39±4.2 years. The duration of the anamnesis ranged from 1 to 8 years (Iu 4 years). The patients were divided into two groups, depending on the therapy performed: Group 1 (n=31) received long-term (more than 1 year) immunosuppressants (azathioprine/6-mercaptopurine/tofacitinib), group 2 (n=35) received anti-TNF-α therapy. The level of SARS-CoV-2 class G immunoglobulins was determined by the immunochemiluminescence method. Results After 4-6 weeks later, after a twice negative smear of PCR from the nose and oropharynx for SARS-CoV-2, in patients (n=31) receiving anti-relapse therapy with systemic IBD (azathioprine/6-mercaptopurine) and selective (tofacitinib) immunosuppressants, the average level of Ig G was 44.1±9.8 U/l. Among patients with IBD receiving anti-TNF-a drugs (n=35), the average level of class G immunoglobulins was 133.6±14.4 U/l. The difference was statistically significant (p=0.000003). Conclusion The level of class G immunoglobulins 3-4 weeks after the COVID-19 infection was significantly higher in IBD patients who received anti-TNF-α drugs.
Background Long-term experience with infliximab (IFХ) shows that within a year, 20–30% of patients with ulcerative colitis (UC) develop acquired drug resistance (secondary inefficiency). Aim To establish the possibility of overcoming the secondary inefficiency of IFX in UC patients using mesenchymal stromal cells (MSC). Methods In the IBD treatment Department, the clinical status of 84 UC patients receiving IFX therapy was evaluated. Secondary loss of response was registered in 28 UC patients, which required optimization of IFX therapy. 12 patients (group 1), in order to overcome the secondary loss of response, were administered MSCS three times every 4 weeks, 16 patients with UC (group 2) received standard optimized IFX therapy. The effectiveness of therapy was evaluated after 12 weeks of therapy (reduction of the Mayo score) and normalization of laboratory parameters (ESR, C-reactive protein (CRP), hemoglobin, fecal calprotectin (FCP). The comparative analysis was carried out using the method of four-field tables using nonparametric statistical criteria. Results In 10 (83.3%) of 12 patients of group 1, a significant positive dynamics was observed after 12 weeks: a decrease in the Mayo index and normalization of laboratory parameters (ESR, CRP, hemoglobin, FCP). In 4 (25.0%) patients with UC from group 2, against the background of optimized IFX therapy, a significant positive dynamics was also observed with a decrease in the meio index and an improvement in ESR, CRP, hemoglobin and FCP levels. However, 12 patients from group 2 were transferred to therapy with other anti-TNF-α drugs and drugs with a different mechanism of action (RR-0.222, 95% CI 0.061–0.812; x2 - 7.146; p=0.00334). Conclusion The use of mesenchymal stromal cells of the bone marrow helps to overcome the secondary loss of response to infliximab in patients with ulcerative colitis.
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