scholarly journals Mayo Endoscopic Score and Ulcerative Colitis Endoscopic Index Are Equally Effective for Endoscopic Activity Evaluation in Ulcerative Colitis Patients in a Real Life Setting

2021 ◽  
Vol 12 (2) ◽  
pp. 217-224
Author(s):  
Cristiano Pagnini ◽  
Maria Carla Di Paolo ◽  
Benedetta Maria Mariani ◽  
Riccardo Urgesi ◽  
Lorella Pallotta ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Real Life ◽  
Observer Agreement ◽  
Activity Evaluation ◽  
Video Recordings ◽  
Real Life Setting ◽  
Bowel Diseases ◽  
Endoscopic Score ◽  
And Performance ◽  
Similar Good

The role of endoscopic evaluation in ulcerative colitis (UC) is well recognized, but a universally accepted gold standard for endoscopic activity evaluation is still lacking, and many scores have been proposed to this purpose. Among these, the Mayo Endoscopic Score (MES) and the Ulcerative Colitis Endoscopic Index (UCEIS) are currently the most used in trials and clinical practice. The aim of the study is to evaluate feasibility and performance of MES and UCEIS among expert endoscopists with no specific expertise in inflammatory bowel diseases (IBD), in a single hospital center. Two minutes video recordings, from colonoscopy of 12 UC patients, were observed and scored, according to MES and UCEIS, by seven hospital gastroenterologists with experience in digestive endoscopy and no particular expertise in IBD. Knowledge and utilization of the two scores were investigated. Inter-observer agreement and agreement with an IBD-expert gastroenterologist of the same center (central reader), and correlation between the two scores, was calculated. Among the endoscopists, MES was much more known and currently used than UCEIS. Both the scores displayed a similar good performance. Agreement with central reader was moderate for MES and UCEIS, and interobserver agreement was good, for both MES and UCEIS. Correlation between the two scores was very good both for central reader and for the hospital endoscopists. This single center study confirmed potential feasibility and usefulness of MES and UCEIS for assessment of endoscopic activity in UC patients in a real-life setting.

Motivational clusters and performance in a real-life setting

2009 ◽  
Vol 33 (1) ◽  
pp. 49-62 ◽  
Author(s):  
Nicolas Gillet ◽  
Robert J. Vallerand ◽  
Elisabeth Rosnet
Keyword(s):  
Real Life ◽  
Real Life Setting ◽  
And Performance

scholarly journals Evaluation of efficacy and comparative frequency of adverse events in patients with ulcerative colitis receiving the original infliximab and its biosimilar. One year of observation

2019 ◽  
Vol 91 (8) ◽  
pp. 41-46
Author(s):  
O V Knyazev ◽  
T V Shkurko ◽  
A V Kagramanova ◽  
A A Lishchinskaya ◽  
M Yu Zvyaglova ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Real Life ◽  
Fecal Calprotectin ◽  
Biologic Drugs ◽  
Real Life Data ◽  
Bowel Diseases ◽  
Significant Clinical Improvement ◽  
One Year

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.

scholarly journals P668 Real-life comparison of different anti-TNF biologic therapies for ulcerative colitis treatment: A retrospective cohort study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S548-S549
Author(s):  
B Barberio ◽  
F Zingone ◽  
R D’Incà ◽  
C Marinelli ◽  
M C Maccarone ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Clinical Remission ◽  
Drug Exposure ◽  
Real Life ◽  
Intention To Treat ◽  
Tnf Α ◽  
Ulcerative Colitis Treatment ◽  
Similar Good

Abstract Background Currently, ulcerative colitis (UC) can be treated with different anti-Tumor Necrosis Factor (TNF) drugs, which selection is mainly based on physician’s perspective. Indeed, head-to-head comparison studies evaluating the effectiveness and tolerability of anti-TNF drugs are lacking. The aim of this study was to compare the effectiveness and tolerability of anti-TNF-α drugs used in clinical practice in a cohort of patients with moderate to severe UC. Methods Retrospectively, 122 UC patients treated with Infliximab (IFX) Originator and Biosimilar, Adalimumab (ADA) and Golimumab (GOL) were included. We performed an intention to treat analysis to evaluate the clinical response, clinical remission, steroid-free clinical remission and endoscopy response according to the different time-points of the follow-up (ie. after induction, at 30 and 52 weeks). Baseline and post-induction predictor factors of these outcomes were evaluated using multivariate logistic regressions models. Data were analyzed using STATA11 software. Results Overall clinical response was 79.5% after induction, 79.5% at 30 weeks, 75.4% at 52 weeks, while the overall steroid-free clinical remission was 42.6%, 45.1%, 55.7%, respectively. After induction, a higher rate of treatment failure was observed in GOL group. Moreover, at the end of follow-up, lower rates of steroid-free clinical remission and clinical response were obtained by GOL (38.7% and 54.8% with p = 0.006 and p = 0.003, respectively). At week 52, endoscopic response was achieved by 46.5% of the population (IFX Originator: 46.7%; IFX Biosimilar: 40%; ADA: 51.6%; GOL: 22.6%; p = 0.003). Conclusion Among the different anti-TNF treatment, moderate-to-severe UC seems to respond better to IFX and ADA, whereas GOL seems to be less effective, despite a similar good safety profile. Current possibility of optimising also GOL will clarify whether these discrepancies are due to reduced drug exposure to GOL.

Efficacy, Safety and Immunogenicity of Biosimilars in Inflammatory Bowel Diseases: A Systematic Review

2019 ◽  
Vol 26 (2) ◽  
pp. 270-279 ◽  
Author(s):  
Laura Martelli ◽  
Laurent Peyrin-Biroulet
Keyword(s):  
Inflammatory Bowel Diseases ◽  
Patent Protection ◽  
Real Life ◽  
Cost Savings ◽  
High Price ◽  
Real World Evidence ◽  
Real Life Setting ◽  
Bowel Diseases ◽  
Post Marketing ◽  
Inflammatory Bowel

Background: Anti-tumor necrosis factor (anti-TNF) monoclonal antibodies have revolutionized the treatment of inflammatory bowel diseases (IBD). However, because of their complexity, their production is expensive contributing to their high price. As the patent protection of these therapies has expired in several countries, biosimilars have been developed to reduce the healthcare costs. The aim of this article is to review the literature on the safety, efficacy and immunogenicity of biosimilars in IBD. </P><P> Methods: A PubMed literature search was performed using the following terms until May 2016: ‘biosimilars’, ‘CT-P13’, ‘infliximab’, ‘Crohn’s disease’, ‘ulcerative colitis’, ‘inflammatory bowel diseases’, ‘efficacy’, ‘safety’, ‘immunogenicity’. Additionally, abstracts from international meetings were also reviewed. </P><P> Results: A total of eleven studies in IBD patients provided real-world evidence on the efficacy, safety and immunogenicity profile of biosimilars in IBD patients. Based on the available evidence, CT-P13 is efficacious and well tolerated in IBD patients in a real-life setting. The vast majority of studies only included IBD patients who had never received biological therapies. Information regarding the interchangeability between CT-P13 and its originator is currently being investigated in the NOR-SWITCH trial. Otherwise, the immunogenicity profile of CT-P13 seems to be similar to the originator. </P><P> Conclusion: The infliximab biosimilar seems to be efficacious, safe and with a similar immunogenicity profile as the originator in IBD. Large prospective post-marketing studies are needed to assess the long-term safety profile of CT-P13. The use of infliximab biosimilars may lead to major healthcare cost savings.

Management of ulcerative colitis in a real-life setting: An Italian multicenter, prospective, observational AIGO study

2019 ◽  
Vol 51 (3) ◽  
pp. 346-351 ◽  
Author(s):  
Maria Lia Scribano ◽  
Claudio Papi ◽  
Francesco Costa ◽  
Aurora Bortoli ◽  
Francesco Bortoluzzi ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Real Life ◽  
Real Life Setting

scholarly journals DOP63 The Toronto IBD global endoscopic reporting (TIGER) score is well correlated with fecal calprotectin and IBD Disk in Ulcerative Colitis patients

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S098-S098
Author(s):  
E Zittan ◽  
A H Steinhart ◽  
H Aran ◽  
R Milgrom ◽  
E Koifman ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Burden ◽  
Fecal Calprotectin ◽  
Kappa Coefficient ◽  
Observer Agreement ◽  
Subject Analysis ◽  
Reactive Protein ◽  
Interclass Correlation ◽  
Endoscopic Score ◽  
Lower Correlation

Abstract Background Commonly used endoscopic indices in IBD lack ability to provide overall disease burden and severity, generate low inter-observer agreement, and demonstrate incomplete validation of some scores. We developed a new endoscopic reporting tool, the Toronto IBD Global Endoscopic Reporting (TIGER) score for Crohn’s disease (CD) and ulcerative colitis (UC) patients. The aim of our study was to compare the usability and validity of the TIGER score against fecal calprotectin (FC), C-reactive protein (CRP) and IBD DISK score in UC patients. Methods A cohort of 53 UC patients participated in the study. Blinded IBD experts reviewed and graded ileocolonoscopy videos. In the validation phase, the TIGER score was compared to (1) the Mayo endoscopic score serving as a reference standard and; (2) inflammatory biomarkers FC, CRP and; (3) IBD Disk. Results Inter-observer reliability of the TIGER score per segment between reviewers was excellent, Interclass Correlation Coefficient (ICC)=0.94; [95%CI: 0.92–0.96]. For categorized TIGER score, lowest overall agreement was 96.6% [95%CI: 93.5–98.6] and lowest kappa 0.91 [95%CI: 0.84–0.98], reflecting excellent agreement. Overall agreement per segment between Mayo endoscopic score and TIGER was 84% [95%CI:74%-90%] and kappa coefficient 0.60 [95%CI: 0.42–0.808]. Per subject analysis for UC yielded overall agreement of 80% [95%CI: 64–91] and kappa coefficient 0.44 [95%CI: 0.14–0.75]. There was a significant correlation between TIGER and FC (r s = .794, p &lt; .0001). There was a significant correlation between TIGER and IBD Disk (r s = .613, p &lt; .0001). As expected, there was a lower correlation between TIGER score and CRP (r s = .309, p &lt; .0850) in UC patients. Conclusion The TIGER endoscopic score demonstrates significant correlation with FC and IBD disk score in ulcerative colitis patients and thus can be used as a reliable and simple endoscopic score for UC patients to capture overall endoscopic disease burden.

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