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.
Background: Previous research has shown smoking to have a deleterious effect on Crohn's Disease (CD) development, with smoking being identified as both a risk factor for CD and associated with poorer outcomes. Previous studies have shown smoking cessation interventions are associated with decreased rates of CD flares and lower rates of disease progression. While previous guidelines have called for increased focus on counseling for smoking cessation amongst CD patients, little research to date has demonstrated to what extent this counseling is routinely provided in an outpatient setting. Methods: We examined the rates of education for tobacco cessation among current and former smokers during visits for CD captured within the National Ambulatory Medical Care Survey (2002-2018) (NAMCS) and The National Hospital Ambulatory Medical Care Survey (2002-2011) (NHAMCS) database, a nationally representative dataset of outpatient visits. Patients with CD were identified using the International Classification of Diseases (ICD)-9-Clinical Modification codes 555.x as well as ICD-10-Clinical Modification codes K50. We analyzed rates of tobacco cessation counseling among all CD visits as well as CD visits for current/former tobacco users. In addition, a multivariable logistic regression model was performed to determine factors associated with rates of tobacco cessation counseling, including age, race, gender, geographic area and insurance type.Results: Among all visits for CD, the overall rate of counseling for tobacco cessation was 2.0% (95% CI: 1.1-3.5). The rate of counseling amongst former or current smokers with CD was slightly higher at 5.4% (95% CI: 2.9-10.0). In addition, rates of smoking cessation counseling were not significantly different between smokers with and without CD (P 5 0.26). In a multivariable logistic regression model, tobacco cessation counseling was less likely at visits with Hispanic patients compared to White, non-Hispanic patients with an aOR (adjusted odds ratio) of 0.06 (95% CI 0.01-0.30). Conclusion(s): Overall, rates of counseling and education for smoking cessation in outpatient CD visits were infrequent. Furthermore, lower rates of smoking cessation were noted in Hispanic patients compared to non-Hispanic patients, a finding documented in several previous studies. Though smoking has an important role in disease course and development, these findings indicate that education on smoking cessation does not frequently occur in the outpatient setting for CD patients. Overall, this highlights the need for increased focus by providers on screening and counseling for tobacco cessation in CD patients.
Inflammatory bowel diseases are autoimmune systemic forms of pathology. The concept of continuous life-long drug intake is a cornerstone in their therapy. The review presents the factors that reduce patients adherence to treatment and ways to improve it. They include informing the patient about the disease and treatment, selection of individual therapy regimen, consolidation of achievements, provision of social support and interaction with other specialists.
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