Background Biosimilars are analogues of biopharmaceutical drugs, with a close, but not identical, parent molecule. Biosimilars offer greater access to affordable treatment for inflammatory bowel disease, while being comparable in efficacy and safety to brand-name products. However, switching from original genetically engineered biological drugs (GEBD) to biosimilars requires study and analysis. Aim To determine the concentration of antibodies to infliximab in patients with UC receiving infliximab by one trade name (TN) and when alternating infliximab and its biosimilars and to determine the frequency of loss of response during the year of observation. Methods In the Department of inflammatory bowel diseases of the A. S. Loginov Moscow Clinical Scientific Center of the Moscow Healthcare Department, were observed 38 patients with IBD, who regularly received the original drug infliximab (IFX) -group 1 (n=20), group 2 a group of patients (n=18) alternated the original drug infliximab and its biosimilar.The level of antibodies to IFX in the blood serum before the next scheduled administration of the drug 10 months after inclusion in the study by enzyme immunoassay using the Shikari Quantitative Determination of Infliximab (Q-INFLIXI) and Shikari Quantitative Determination of Antibodies to Infliximab (Q-ATI) kits (Matriks Biotek). The loss of response was assessed by clinical, laboratory and instrumental data. Comparative analysis was carried out by the method of four-field tables using non-parametric statistical tests. Results Of the 20 patients with UC of the 1-st group, 3 (15.0%) had antibodies to IFX, on average, its concentration was 8.5 ± 2.2 ng/ml (normal values <5 ng/ml). Of the 18 patients of the 2nd group 10 (55.5%) antibodies to IFX were detected, on average - 187.9 ± 38.2 ng/ml. (OR - 0.141; 95% CI 0.030-0.658; x2 - 6.923, p= 0.023).During the year of observation among patients of the 1st group receiving the original IFX, the loss of response occurred in 2 (10.0%) patients with UC. Of the patients of the 2nd group, the loss of response occurred in 8 (10.0%) (RR - 0.139; 95% CI 0.025 - 0.785; x2 - 5.797; p = 0.017). Conclusion The concentration of antibodies to infliximab is higher in patients with UC when alternating IFX and its biosimilars than in patients with UC who regularly receive IFX by one TN. The frequency of loss of response when alternating infliximab and its biosimilars is significantly higher in patients with UC who regularly receive the drug for one TN.
Introduction. Inflammatory bowel diseases are a group of chronic, immune-mediated diseases of unknown etiology. Etiotropic therapy of IBD does not exist, all drugs used to treat IBD have a pathogenetic effect. In the treatment of IBD biologic therapy is used. The most previously registered group of biologics are anti-TNF-α. But, after the expiration of the relevant patents, biosimilars appeared on the market (analogs, comparable in quality to the already approved reference product).Materials and methods. A retrospective study was conducted on the basis of the Ryzhikh Natianal Medical Research Centre for Coloproctology of the Ministry of Health of the Russia, which included 46 patients who switched from therapy with the original infliximab or adalimumab to biosimilar therapy.Discussion. This study showed that when switching therapy with the original drugs infliximab and adalimumab to biosimilars, the effectiveness of therapy does not significantly decrease with the use of biosimilars Infliximab BIOCAD and Dalibra. However, a statistically significant decrease in efficacy was revealed when switching from therapy with the original Infliximab to Flammegis. Considering that the use of biosimilars can reduce the cost of treatment and reduce the burden on the health budget, it is necessary to continue this study in order to obtain longer-term results.
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.
Introduction. Tofacitinib is the first member of a new class of targeted synthetic anti-inflammatory drugs for the treatment of ulcerative colitis (UC). The article presents a three-year Russian experience of tofacitinib use for the treatment of moderate and severe UC.Aim of the study. To evaluate the efficacy and safety of tofacitinib therapy in real clinical practice in moderate to severe UC patients during three years of follow-up. Methods. The study included 56 patients with UC who had moderate (60.7%) and severe (35.8%) states of disease, the total lesion was diagnosed in 67.8%, and extraintestinal manifestations in 57.1% of patients. Early achievement of clinical response, clinical and endoscopic, corticosteroid-free remission, and safety were evaluated.Results. Early response to tofacitinib therapy was obtained in 47 (83.9%) patients. Clinical remission was achieved in 36 (64.3%) at week 8 of therapy and clinical response was achieved in 13 (23.2%) patients. The majority of patients who achieved clinical remission at weeks 8 and 12 achieved healing of colon mucosa at week 24. Clinical and endoscopic remission rates after 24 weeks – 44 (78.6%) patients, clinical response in 7 (12.5%) patients, 5 (8.9%) did not respond to TFCB therapy. Corticosteroidfree remission was 77.6%. After 2 years of tofacitinib therapy, remission of UC was maintained in 46 (82.1%). After 36 months, remission of UC was maintained in 45 (80.3%) of the 56 patients who had been started on tofacitinib therapy. The cumulative effect of survival in the treatment of tofacitinib in UC was 87.5% after 6 months and persisted for one year, 82.1% after 2 years, and 80.3% after 3 years.Conclusions. The administration of tofacitinib in UC is effective in achieving rapid clinical response, clinical remission, and mucosal healing in patients who do not respond well to biological therapy.
Case: Hepatic abscesses are a rare extraintestinal manifestation of inflammatory bowel disease (IBD) with only 60 cases reported in the literature, the majority of which being in Crohn's disease (CD) patients. In ulcerative colitis (UC) patients, Streptococcus is the most common pathogen identified in hepatic abscesses followed by Escherichia coli, and Staphylococcus aureus is the most common cultured hepatic abscess aspirate from Crohn's disease patients. In extremely rare cases, however, no pathogen is isolated, and these so-called visceral aseptic hepatic abscesses represent part of the spectrum of neutrophilic disease and an extremely rare manifestation of IBD. Our case illustrates a middle-aged female with Crohn's disease on adalimumab presenting with an aseptic hepatic abscess. A 49-year-old female with a history of longstanding Crohn's disease on adalimumab status-post partial ileal resection, atrial fibrillation on apixaban, chronic obstructive pulmonary disease, lupus, and hypothyroidism presented for 2 days of cramping right hemi-abdominal pain, fever, and vomiting. Her vitals were within normal limits. Labs showed a mild leukocytosis of 11.1 with neutrophilic predominance, an erythrocyte sedimentation rate of 67, and a C-reactive protein of 20.64. The rest of her labs were unremarkable. Computed tomography (CT) of the abdomen/pelvis showed a subcapsular 2.4 x 2.3 x 1.7 cm rim-enhancing abscess within segment 5 of the liver with central and peripheral hypodensity. There was also a short segment of proximal ascending colon wall thickening most consistent with an inflammatory colitis. She was given ceftriaxone and metronidazole in the emergency department. Repeat CT the following day showed an increase in abscess size, now measuring 3.4 x 3.3 x 3.1 cm. The patient was switched to piperacillin-tazobactam per Infectious Disease recommendations due to concerns for hepatic inoculation from Crohn's colitis and underwent an ultrasound-guided placement of a percutaneous drainage catheter into the abscess by Interventional Radiology 2 days later. Fluid cultures were remarkably negative for any organisms. Post-procedure, with continued catheter drainage, the patient reported significant improvement of symptoms. She was discharged along with removal of her catheter on hospital day 14 with instructions to hold her adalimumab until follow-up in clinic. There are only 7 other reports of aseptic abscesses in the literature as the presenting manifestation of Crohn's disease. Multiple theories have been purported regarding the development of hepatic abscesses in IBD patients. One proposes that ulceration and loss of mucosal barrier integrity leads to microbial invasion of the portal venous system with parenchymal seeding. Another suggests that the increased incidence of cholelithiasis and primary sclerosing cholangitis in IBD patients leads to ascending cholangitis and dissemination of bacteria up the biliary tree to seed the liver. Biologics and other immunosuppressives have also been suggested to reactivate chronic inf...
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