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Objective: Subcutaneous (SC) infliximab (IFX) and vedolizumab (VDZ) have recently become available. We aimed to examine the impact of switching from intravenous (IV) to SC IFX and VDZ in patients with inflammatory bowel disease (IBD) on costs, the day hospital burden, trough levels, and clinical outcomes., Methods: Our study comprised the cohort of IBD patients receiving IV IFX or VDZ at our hospital in 2022. We evaluated costs, day hospital visits, trough levels, biochemical markers, relapse rates, and self-report outcomes until Jun 30 th 2023., Results: Of 114 patients, 18 continued IV therapy, 80 were switched to SC therapy, and 16 were inductions. Eighty-eight (90%) remained in steroid-free remission with no difference between the IV or SC groups. The mean IFX trough level changed from 8.2 ± 4.5 µg/ml to 14.5 ± 5.9 µg/ml, p  < 0.001, and the VDZ trough level from 14.7 ± 7.1 mg/ml to 26.5 ± 13.8 mg/ml, p  < 0.001. The average yearly costs of infusions and injections per patient were 2 580 € and 7 482 € for IFX and 15 990 € and 13 101 € for VDZ. The annual reduction of day hospital visits was 6,9 per patient., Conclusions: IV and SC IFX and VDZ are equally effective in maintaining remission in IBD, but SC administration reduces day hospital visits and results in higher trough levels. SC VDZ is less and SC IFX more expensive than IV therapy. Further studies are needed to assess optimal dosing and separate trough levels for SC therapy.

Background and Aims: There are limited comparative data for infliximab and vedolizumab in inflammatory bowel disease patients., Methods: We conducted a systematic review and meta-analysis to compare the efficacy and safety of infliximab and vedolizumab in adult patients with moderate-to-severe Crohn's disease or ulcerative colitis., Results: We identified six eligible Crohn's disease and seven eligible ulcerative colitis trials that randomised over 1900 participants per disease cohort to infliximab or vedolizumab. In the Crohn's disease and ulcerative colitis cohorts, infliximab yielded better efficacy than vedolizumab for all analysed outcomes (CDAI-70, CDAI-100 responses, and clinical remission for Crohn's disease and clinical response and clinical remission for ulcerative colitis) during the induction phase, with non-overlapping 95% confidence intervals. In the maintenance phase, similar proportions of infliximab- or vedolizumab-treated patients achieved clinical response, clinical remission, or mucosal healing in both Crohn's disease and ulcerative colitis. For the safety outcomes, rates of adverse events, serious adverse events, and discontinuations due to adverse events were similar in infliximab- and vedolizumab-treated patients in both diseases. The infection rate was higher in infliximab for Crohn's disease and higher in vedolizumab when treating patients with ulcerative colitis. There was no difference between the treatments in the proportions of patients who reported serious infections in both indications., Conclusions: Indirect comparison of infliximab and vedolizumab trials in adult patients with moderate-to severe Crohn's disease or ulcerative colitis demonstrated that infliximab has better efficacy in the induction phase and comparable efficacy during the maintenance phase and overall safety profile compared to vedolizumab., (© 2022. The Author(s).)

Effectiveness, efficacy and safety of biosimilar infliximab (CT-P13) in inflammatory bowel disease (IBD) patients has been shown in previous studies. Limited data exist on health-related quality of life (HRQoL) of switching originator to biosimilar infliximab (IFX) in IBD patients. The objective of this study was to evaluate impact of switching originator to biosimilar IFX on HRQoL, disease activity, and health care costs in IBD maintenance treatment.In this single-center prospective observational study, all IBD patients receiving maintenance IFX therapy were switched to biosimilar IFX. HRQoL was measured using the generic 15D health-related quality of life instrument (15D) utility measurement and the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ). Crohn Disease Activity Index (CDAI) or Partial Mayo Score (pMayo), and fecal calprotectin (FC) served for evaluation of disease activity. Data were collected at time of switching and 3 and 12 months after switching. Patients' characteristics, clinical background information and costs were collected from patient records and the hospital's electronic database.Fifty-four patients were included in the analysis. No statistically significant changes were observed in 15D, CDAI, pMayo, and FC during 1-year follow-up. IBDQ scores were higher (P = .018) in Crohn disease 3 months after switching than at time of switching. Costs of biosimilar IFX were one-third of costs of originator one. Total costs related to secondary health care (excluding costs of IFX), were similar before and after the onset of biosimilar IFX.HRQoL and disease activity were after switching from originator to biosimilar IFX comparable, but the costs of biosimilar IFX were only one-third of those of the originator one.

Background: Inflammatory bowel disease (IBD) has a substantial impact on patients health-related quality of life (HRQoL). In this study, we examined the impact of adaptation courses on HRQoL, psychological well-being, depression and number of sick-leave days of IBD patients., Methods: The study recruited 142 IBD patients attending an adaptation course of 5-12 days. The courses were specially designed for IBD patients and included multidisciplinary information about IBD, peer support, group activities and encouragement for adequate physical exercise. The participants completed the study questionnaire at the beginning and the end of the course and after six and 12 months of follow-up. HRQoL was assessed with the generic 15-dimensional (15D) tool and depression with Beck's Depression Inventory (BDI). Utilization of health care services and work absenteeism was also assessed. Visual analog scales were used for assessing psychological functioning., Results: 15D, BDI scores and scores describing psychological well-being were significantly better at the end of the course when compared to baseline (15D 0.82 vs. 0.84, p < .001; BDI 11.8 vs. 8.5, p < .001). Positive results were maintained during follow up. The percentage of patients receiving peer support rose from 32 to 70% and those with peer support had better HRQoL at the 12-month follow-up (p = .01). No significant change in health care utilization or number of sick-leave days was observed., Conclusion: Adaptation training appears to have a positive impact on the psychological well-being of IBD patients. Peer support appears to be an important factor.

Objective: Characterization of predisposing factors for Clostridium difficile infection recurrence (rCDI) and outcome in inflammatory bowel disease (IBD) patients., Methods: Clinical characteristics of 167 inflammatory bowel disease patients with Clostridium difficile infection (IBD-CDI cohort) treated in Helsinki University Central Hospital were gathered. Medical history of the last three months preceding a toxin positive CDI test was recorded. Parameters, including ribotype of C. difficile, mortality and recurrence were compared with age and gender-matched C. difficile patients (CDI cohort)., Results: No difference was found in rCDI between IBD-CDI and CDI cohorts. As compared with IBD subtypes, rCDI was least common among patients with Crohn's disease. The use of immunosuppressant therapy was higher in IBD patients with two or more CDI episodes. C. difficile ribotype 027 increased the rates for rCDI in IBD patients but not in non-IBD-CDI patients. The prevalence of 027 ribotype and mortality rates did not differ significantly among the cohorts. None of the IBD patients underwent colectomy upon CDI., Conclusion: IBD patients are not more susceptible for rCDI than non-IBD patients. Predisposing factors for rCDI among IBD patients are associated with immunosuppressant treatments, colon affecting IBD and CDI caused by ribotype 027. CDI does not worsen the prognosis of IBD patients.

Objectives: The main objective of our study was to determinate the effectiveness of intravenous iron treatment with ferric carboxymaltose in inflammatory bowel disease (IBD) patients. Our other objectives were to study parameters that would predict a good response to the treatment and to chart out possible side-effects of the treatment., Materials and Methods: In our retrospective chart review study we collected clinical data and laboratory results related to IBD from medical records of 87 IBD patients who were treated with ferric carboxymaltose in Helsinki University Hospital between 2014 and 2016., Results: The mean increase in hemoglobin levels of the patients was 24.6 g/l (+ 24%) after one month, 27.6 g/l (+ 27%) after three months and 26.0 g/l (+ 27%) after six months. Nine out of 87 treated patients (10.3%) reported side-effects during the iron infusion. A linear regression model assessing the change in hemoglobin levels after six months demonstrated close correlation with transferrin receptor count (p = .004) and ferritin (p = .016) with an adjusted R square of 0.463., Conclusion: Ferric carboxymaltose was found to be an effective and well tolerated treatment for iron deficiency anemia in patients with IBD. The results of our study further strengthen the current knowledge of the effectiveness and safety of the treatment.

Background: Faecal microbiota transplantation or transfer (FMT) aims at replacing or reinforcing the gut microbiota of a patient with the microbiota from a healthy donor. Not many controlled or randomised studies have been published evaluating the use of FMT for other diseases than Clostridium difficile infection, making it difficult for clinicians to decide on a suitable indication., Aim: To provide an expert consensus on current clinical indications, applications and methodological aspects of FMT., Methods: Well-acknowledged experts from various countries in Europe have contributed to this article. After literature review, consensus has been achieved by repetitive circulation of the statements and the full manuscript among all authors with intermittent adaptation to comments (using a modified Delphi process). Levels of evidence and agreement were rated according to the GRADE system. Consensus was defined a priori as agreement by at least 75% of the authors., Results: Key recommendations include the use of FMT in recurrent C. difficile infection characterised by at least two previous standard treatments without persistent cure, as well as its consideration in severe and severe-complicated C. difficile infection as an alternative to total colectomy in case of early failure of antimicrobial therapy. FMT in inflammatory bowel diseases (IBD), irritable bowel syndrome (IBS) and metabolic syndrome should only be performed in research settings., Conclusions: Faecal microbiota transplantation or transfer is a promising treatment for a variety of diseases in which the intestinal microbiota is disturbed. For indications other than C. difficile infection, more evidence is needed before more concrete recommendations can be made., (© 2016 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)

Background and Aims: This prospective multicenter study examined whether elevated fecal calprotec tin (FC) concentrations after stopping TNFα-blocking therapy can predict clinical or endoscopic relapse. In addition, we evaluated the impact of histological remission on the relapse risk., Methods: We enrolled inflammatory bowel disease (IBD) patients who were in clinical, endoscopic, and FC-based (< 100 μg/g) remission after a minimum 11 months of TNFα-blocking therapy. The patients were followed-up for 12 months after the discontinuation of TNFα-blocking therapy. FC was collected monthly for the first 6 months and thereafter every second month. Ileocolonoscopy was performed at inclusion, at 4 months, at the study end, and at the time of clinical relapse., Results: Of 52 enrolled patients, 49 (16 Crohn's disease, 33 ulcerative colitis/IBD unclassified) provided the stool samples requested and comprised the study group. During the follow-up, 15/49 (31%) relapsed, whereas 34 (69%) remained in remission. Patients relapsing showed constantly elevated FC levels for a median of 94 (13-317) days before the relapse. Significant increase in median FC levels was seen 2 (p = 0.0014), 4 (p = 0.0056), and 6 (p = 0.0029) months before endoscopic relapse. Constantly normal FC concentrations during the follow-up were highly predictive for clinical and endoscopic remission. Normal FC concentrations in patients with remission were associated with histological remission., Conclusion: FC seems to increase and remain elevated before clinical or endoscopic relapse, suggesting that it can be used as a surrogate marker for predicting and identifying patients requiring close follow-up in clinical practice., (Copyright © 2014 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: The aim of this study was to explore the utilization of health services by Finnish adults with inflammatory bowel disease (IBD) and to assess the associated demographic and health-related quality of life (HRQoL) factors., Material and Methods: 556 Finnish IBD patients eligible for reimbursement for IBD medication according to the Social Insurance Institution in Finland answered our postal cross-sectional survey. The study questionnaire included questions about demographic characteristics of the patients, health care resource use, and HRQoL. The number of doctor visits was compared with those of irritable bowel syndrome patients., Results: During the previous year, more than three quarters of the respondents reported disturbing IBD symptoms. The majority (64%) had seen a doctor due to their IBD, women more often than men (p < 0.001). The use of health services did not differ between diagnostic (Crohn's disease or ulcerative colitis) or age groups, marital status, education, or time elapsed since diagnosis. Women were absent from work more frequently than men (p = 0.01). The amount of physician visits, work absenteeism, and a higher amount of undergone procedures were related to impaired HRQoL (p < 0.001 on all accounts)., Conclusions: Despite comprehensive public health services and specialized care for IBD patients in Finland, a majority expressed disturbing IBD symptoms. Since the amount of physician visits, work absenteeism and a higher amount of procedures were related to a diminished HRQoL, the patients who are most often met by professional caregivers are often those whose HRQoL needs to be more adequately addressed.

Background: Infliximab and vedolizumab are widely used to treat Crohn's disease (CD) and ulcerative colitis (UC). Aims: This systematic review and network meta-analysis evaluated comparative efficacy of various regimens for intravenous or subcutaneous infliximab and vedolizumab during maintenance treatment in CD and UC. Methods: Parallel-group randomized controlled trials (RCTs) were identified by a systematic literature review (CRD42022383401) and included if they evaluated therapeutics of interest for maintenance treatment of adults with moderate-to-severe luminal CD or UC and assessed clinical remission between Weeks 30 and 60. Clinical remission rates in CD or UC and mucosal healing rates in UC were analyzed in a Bayesian network meta-analysis model. Endoscopic outcomes in CD were synthesized by proportional meta-analysis. Results: Overall, 13 RCTs were included in the analyses. All vedolizumab studies randomized induction responders to maintenance treatment; infliximab studies used a treat-through design. Subcutaneous infliximab 120 mg every 2 weeks had the highest odds ratio (OR) [95% credible interval] versus placebo for clinical remission during the maintenance phase (CD: 5.90 [1.90–18.2]; UC: 5.45 [1.94–15.3]), with surface under the cumulative ranking curve (SUCRA) values of 0.91 and 0.82, respectively. For mucosal healing in UC, subcutaneous infliximab 120 mg every 2 weeks showed the highest OR (4.90 [1.63–14.1]), with SUCRA value of 0.73, followed by intravenous vedolizumab 300 mg every 4 weeks (SUCRA value, 0.70). Endoscopic outcomes in CD were better with subcutaneous infliximab 120 mg every 2 weeks than intravenous infliximab 5 mg/kg every 8 weeks. Conclusions: Subcutaneous infliximab showed a favorable efficacy profile for achieving clinical remission and endoscopic outcomes during maintenance treatment in CD or UC. [ABSTRACT FROM AUTHOR]

Abstract: Background and aims: Patients with inflammatory bowel diseases (IBD) show increased risk for other immune-mediated diseases such as arthritis, ankylosing spondylitis, and some pulmonary diseases. Less is known about the prevalence of other chronic diseases in IBD, and the impact of comorbidity on health-related quality of life (HRQoL). Methods: The study population comprised 2831 IBD patients recruited from the National Health Insurance register and from a patient-association register. Study subjects completed generic 15D and disease-specific IBDQ questionnaires. The Social Insurance Institution of Finland provided data on other chronic diseases entitling patients to reimbursed medication. For each study subject, two controls, matched for age, sex, and hospital district, were chosen. Results: A significant increase existed in prevalence of connective tissue diseases, pernicious anemia and asthma. Furthermore, coronary heart disease (CHD) occurred significantly more frequently in IBD patients than in their peers (p =0.004). The difference was, however, more clearly seen in females (p =0.014 versus 0.046 in males). Active and long-lasting IBD were risk factors. Concomitant other chronic diseases appeared to impair HRQoL. Asthma, hypertension and psychological disorders had an especially strong negative impact on HRQoL, as observed with both the generic and disease-specific HRQoL tools. Conclusions: In addition to many immune-mediated diseases, CHD appeared to be more common in IBD than in control patients, especially in females. The reason is unknown, but chronic inflammation may predispose to atherosclerosis. This finding should encourage more efficacious management of underlying cardiovascular risk factors, and probably also inflammatory activity in IBD. [ABSTRACT FROM AUTHOR]