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

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.

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Ulcerative Colitis Endoscopic Index of Severity is Feasible and Useful for Evaluation of Endoscopic Activity in Ulcerative Colitis Patients in a Real-life Setting

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjx155 ◽

2017 ◽

Vol 12 (3) ◽

pp. 383-384

Author(s):

Cristiano Pagnini ◽

Benedetta Maria Mariani ◽

Roberto Lorenzetti

Keyword(s):

Ulcerative Colitis ◽

Real Life ◽

Real Life Setting ◽

Index Of Severity

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Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn’s disease or ulcerative colitis

Journal of Drug Assessment ◽

10.1080/21556660.2019.1626735 ◽

2019 ◽

Vol 8 (1) ◽

pp. 129-134 ◽

Cited By ~ 4

Author(s):

Cristian Gheorghe ◽

Pavel Svoboda ◽

Bogdan Mateescu

Keyword(s):

Ulcerative Colitis ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Real Life ◽

Real Life Setting

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P420 Effectiveness and safety of biosimilar infliximab (remsima) in a real-life setting in 84 patients with Crohn’s disease and ulcerative colitis

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjx180.547 ◽

2018 ◽

Vol 12 (supplement_1) ◽

pp. S316-S317

Author(s):

C Gheorghe ◽

P Svoboda ◽

A Dimitriu ◽

B Mateescu ◽

I Kotzev

Keyword(s):

Ulcerative Colitis ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Real Life ◽

Real Life Setting

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P289 A French nationwide prospective study on patients with Crohn’s disease and ulcerative colitis treated with Infliximab-biosimilar CT-P13 in a real-life setting: two-year follow-up of the ReFLECT study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.413 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S320-S321

Author(s):

Y Bouhnik ◽

S Nancey ◽

M Assing ◽

N Mammar ◽

D Laharie

Keyword(s):

Ulcerative Colitis ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Disease Activity ◽

Safety Data ◽

Real Life ◽

Life Study ◽

Mayo Score ◽

Real Life Setting

Abstract Background ReFLECT study was carried out to investigate real-life use of CT-P13, the first monoclonal antibody biosimilar to infliximab (IFX) originator. Methods This multicentre, prospective, observational study was conducted in France to assess characteristics of patients (pts) receiving CT-P13, its effectiveness and safety in a real-life setting. Eligible were both pts who had been switched from IFX originator (IFXS) and IFX-naïve pts started on CT-P13 (IFXN). These interim descriptive statistical analyses are about pts with Crohn’s disease (CD) and ulcerative colitis (UC). Results Among the 1370 adult pts included between October 2016 and April 2019, data were analysed for 508 CD pts (48.6% males; mean age ± SD: 37.7±13.7; median [Q1;Q3] disease duration: 6.2 [1.9;13.7] years; 323 IFXN/145 IFXS) and 213 UC pts (54%; 42.9±17.2; 5.4 [1.6;12.8]; 154 IFXN/46 IFXS). Previous biologics other than IFX were taken by 32.9% of CD and 39.0% of UC pts; 31% (CDS) and 23% (UCS) of pts were switched from IFX originator to CT-P13. At the time of the first administration of CT-P13, disease had been more active in IFXN vs IFXS pts: 52.9% vs 13.3% in CD with a median [Q1;Q3] Harvey Bradshaw Index (HBI) of 4 [1;8] vs 1 [0;2] and, 82.9% vs 33.3% in UC with a median Mayo Score of 7 [3;10] vs 2 [0;4]. In IFXS pts, disease activity remained stable after 2 years of treatment with median differences of HBI and Mayo score since first administration of 1 [0;2] and 0 [-4;1]. In IFXN pts, median differences of HBI and Mayo score since first administration were -2 [-7;1] and -7 [-8;-5]; CT-P13 brought disease activity down to levels below or comparable to those seen in IFXS pts. Reasons for CT-P13 withdrawing and safety data are reported in Tables 1 and 2. Conclusion Year 2 follow-up data indicate that CT-P13 effectively induced improvement in disease activity in IFXN pts with CD or UC and maintained stable activity in IFXS pts. This real-life study did not highlight any new safety concerns.

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