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

2019 ◽  
Vol 8 (1) ◽  
pp. 129-134 ◽  
Author(s):  
Cristian Gheorghe ◽  
Pavel Svoboda ◽  
Bogdan Mateescu
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real Life ◽  
Real Life Setting

scholarly journals 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

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.

Effectiveness of Mesalazine, Thiopurines and Tumour Necrosis Factor Antagonists in Preventing Post-Operative Crohn's Disease Recurrence in a Real-Life Setting

Digestion ◽  
2017 ◽  
Vol 96 (3) ◽  
pp. 166-172 ◽  
Author(s):  
Mariangela Allocca ◽  
Rosario Landi ◽  
Stefanos Bonovas ◽  
Gionata Fiorino ◽  
Alfredo Papa ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Real Life ◽  
Disease Recurrence ◽  
Real Life Setting ◽  
Necrosis Factor

scholarly journals Good efficacy and safety of vedolizumab in Crohn’s disease and ulcerative colitis in a real-world scenario

2020 ◽  
Vol 13 ◽  
pp. 175628482093653
Author(s):  
Fabiana Zingone ◽  
Brigida Barberio ◽  
Federico Compostella ◽  
Giulia Girardin ◽  
Renata D’Incà ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Benefit ◽  
Real Life ◽  
University Hospital ◽  
Treatment Optimization ◽  
Serious Adverse Events ◽  
Inflammatory Bowel ◽  
The University

Background: Data on vedolizumab (VDZ) use in inflammatory bowel disease (IBD) patients are still limited. We aimed to assess the effectiveness and tolerability of VDZ in a real-life clinical scenario. Methods: We retrospectively collected data of all consecutive IBD patients who started VDZ from September 2016 to December 2018 at our IBD Unit of the University Hospital of Padua and strictly followed them for 1 year. Clinical benefit (rate of clinical steroid-free remission plus clinical response), endoscopic and histological responses were evaluated over 1 year. Results: A total of 117 patients who started VDZ for Crohn’s disease (CD) and ulcerative colitis (UC) were included in the main analysis (69 CD patients, 48 UC patients). We obtained a clinical benefit in 68.1%, 68.1% and 59.4% of CD patients and in 68.7%, 54.2% and 54.1% of UC patients after induction, and at 30 weeks and 52 weeks, respectively. After 1 year, endoscopy response was observed in 47% of CD and 38.2% of UC patients, while the histological response was 19.6% and 23.5%, respectively. Finally, we found that 20.5% of patients needed treatment optimization, with 33.3% of them failing to respond despite this action. No deaths or serious adverse events requiring hospitalization were observed. The main cause of VDZ interruption was drug inefficacy. During the study, two patients developed new spondylarthritis, and two had a worsening of pre-existing arthralgia. Conclusion: Vedolizumab resulted in being effective and safe in CD as well as in UC patients.

An Anti-migration Self-expandable and Removable Metal Stent for Crohn’s Disease Strictures: A Nationwide Study From GETAID and SFED

2020 ◽  
Author(s):  
Alain Attar ◽  
Julien Branche ◽  
Emmanuel Coron ◽  
Jocelyn Privat ◽  
Ludovic Caillo ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Balloon Dilation ◽  
Real Life ◽  
Lower Probability ◽  
Metal Stent ◽  
Cross Sectional ◽  
Real Life Setting ◽  
Cross Sectional Imaging ◽  
Short And Long Term

Abstract Background and Aims In Crohn’s disease, strictures are frequent and may require surgical resection or endoscopic balloon dilation. An anti-migration, removable and shaped self-expandable metal stent is available. We evaluated its effectiveness and safety in a real-life setting. Methods All centres were asked to collect retrospectively or prospectively all data on patients who had a stent for a stricture. The anti-migration stent [Hanarostent HRC-20-080-230—MITech, Seoul, South Korea] was maintained 7 days before its extraction during a second colonoscopy. Short- and long-term efficacy and safety outcomes were evaluated. Results A total of 46 patients were enrolled. Strictures were anastomotic in 73.9% of cases. The median length of the stricture evaluated by cross-sectional imaging and during colonoscopy was 3.1 ± 1.7 and 2.7 ± 1.4 cm, respectively. Immediate success [no obstructive symptom at Day 30] was reported in 93.5% of cases (95% confidence interval [CI] = [86.3; 99.9]). Sixteen patients needed a new balloon dilation [n = 8] or surgery [n = 8]. The overall success rate [obstruction-free without any intervention] was 58.7% [n = 27] after a median follow-up of 26 months [8–41 months]. No perforation occurred and three migrations were observed [6.5%]. Perianal disease (hazard ratio [HR] = 0.1 [0.02; 0.58]) and discontinuation of an immunosuppressant (0.12 [0.02; 0.86]), were associated with a lower probability of success, whereas performing imaging (HR = 5.3 [1.2; 23.5]) before stent placement was associated with success. Conclusions The anti-migration stent is safe and effective in about half of patients, with no perforation reported in this study, and has an extremely low migration rate.

Mannan-binding lectin gene polymorphisms in ulcerative colitis and Crohn's disease

2001 ◽  
Vol 120 (5) ◽  
pp. A459-A459
Author(s):  
A RECTOR ◽  
P LEMEY ◽  
W LAFFUT ◽  
E KEYAERTS ◽  
F STRUYF ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Gene Polymorphisms ◽  
Lectin Gene ◽  
Mannan Binding Lectin ◽  
Binding Lectin
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