Real-Life Efficacy, Immunogenicity and Safety of Biosimilar Infliximab

2017 ◽  
Vol 35 (1-2) ◽  
pp. 101-106 ◽  
Author(s):  
Zsuzsanna Vegh ◽  
Zsuzsanna Kurti ◽  
Peter L. Lakatos
Keyword(s):  
Inflammatory Bowel Diseases ◽  
Real Life ◽  
Mucosal Healing ◽  
European Countries ◽  
Present Review ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Maintenance Of Remission

Recently, the use of biosimilar infliximab (IFX) in the treatment of inflammatory bowel diseases has become widespread in some European and non-European countries. Data on the efficacy, safety and immunogenicity from real-life cohorts are accumulating. The first reports showed similar outcomes in the induction and maintenance of remission, mucosal healing, safety and immunogenicity profile to the originator IFX. In the present review, we aimed to summarize the existing knowledge on the efficacy, safety and immunogenicity profile of biosimilar IFX reported from real-life cohorts.

Effectiveness and Safety of Golimumab in Treating Outpatient Ulcerative Colitis: A Real-Life Prospective, Multicentre, Observational Study in Primary Inflammatory Bowel Diseases Centers

2017 ◽  
Vol 26 (3) ◽  
pp. 239-244 ◽  
Author(s):  
Antonio Tursi ◽  
Leonardo Allegretta ◽  
Nello Buccianti ◽  
Nicola Della Valle ◽  
Walter Elisei ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Diseases ◽  
Real Life ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Background & Aims: Golimumab (GOL) has been recently approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments. Our aims were to assess the real-life efficacy and safety of GOL in managing UC outpatients in Italian primary Inflammatory Bowel Diseases (IBD) centres.Methods: Consecutive UC outpatients with at least 3-months follow-up were enrolled. Primary end-point was the induction and maintenance of remission in UC, defined as Mayo score ≤2, at 6-month follow-up.Results: Ninety-three patients were enrolled. At 6-month follow-up, remission was obtained in 34 (36.5%) patients. Shorter duration of disease was the only significant predictive factor of remission. Clinical response was achieved in 60 (64.5%) patients, while mucosal healing (MH) was obtained in 18 (19.3%) patients. Sixteen (47.0%) patients under remission were still under therapy with steroids. C-reactive protein and fecal calprotectin significantly dropped during the follow-up (p<0.001 for both proteins). Adverse events occurred in 4 (4.3%) patients and 3 of them stopped treatment. Colectomy was performed in only one patient (1.1%).Conclusions: Golimumab seems to be safe and effective in inducing and maintaining remission in real life UC outpatients.Abbreviations: ADA: Adalimumab; CRP: C-reactive Protein; GOL: Golimumab; FC: Fecal calprotectin; IBD: Inflammatory Bowel Diseases; IFX: Infliximab; IQR: Interquartile range; MH: Mucosal Healing; SC: Subcutaneously; TBC: Tuberculosis; TNFα: Tumor necrosis factor α; UC: Ulcerative Colitis.    

scholarly journals Predictors and Early Markers of Response to Biological Therapies in Inflammatory Bowel Diseases

2021 ◽  
Vol 10 (4) ◽  
pp. 853
Author(s):  
Giuseppe Privitera ◽  
Daniela Pugliese ◽  
Gian Ludovico Rapaccini ◽  
Antonio Gasbarrini ◽  
Alessandro Armuzzi ◽  
...  
Keyword(s):  
Inflammatory Bowel Diseases ◽  
Current Knowledge ◽  
Real Life ◽  
Response To Therapy ◽  
Significant Heterogeneity ◽  
Intestinal Damage ◽  
Biological Therapies ◽  
Early Markers ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Inflammatory bowel diseases (IBD) are chronic conditions that primarily affect the gastrointestinal tract, with a complex pathogenesis; they are characterized by a significant heterogeneity of clinical presentations and of inflammatory pathways that sustain intestinal damage. After the introduction of the first biological therapies, the pipeline of therapies for IBD has been constantly expanding, and a significant number of new molecules is expected in the next few years. Evidence from clinical trials and real-life experiences has taught us that up to 40% of patients do not respond to a specific drug. Unfortunately, to date, clinicians lack a valid tool that can predict each patient’s response to therapies and that could help them in choosing what drug to administer. Several candidate biomarkers have been investigated so far, with conflicting results: clinical, genetic, immunological, pharmacokinetic and microbial markers have been tested, but no ideal marker has been identified so far. Based on recent evidence, multiparametric models seemingly hold the greatest potential for predicting response to therapy. In this narrative review, we aim to summarize the current knowledge on predictors and early markers of response to biological therapies in IBD.

Vedolizumab for the treatment of inflammatory bowel diseases: from symptomatic control to mucosal healing

Immunotherapy ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 565-575
Author(s):  
Ferdinando D’Amico ◽  
Gionata Fiorino ◽  
Laurent Peyrin-Biroulet ◽  
Silvio Danese
Keyword(s):  
Inflammatory Bowel Diseases ◽  
Mucosal Healing ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Symptomatic Control

scholarly journals Resolution of Inflammation and Gut Repair in IBD: Translational Steps Towards Complete Mucosal Healing

2020 ◽  
Vol 26 (8) ◽  
pp. 1131-1143 ◽  
Author(s):  
Gwo-tzer Ho ◽  
Jennifer A Cartwright ◽  
Emily J Thompson ◽  
Calum C Bain ◽  
Adriano G Rossi
Keyword(s):  
Inflammatory Bowel Diseases ◽  
Inflammatory Cell ◽  
Mucosal Healing ◽  
Treatment Target ◽  
Resolution Of Inflammation ◽  
Epithelial Repair ◽  
New Knowledge ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Macrophage Populations

Abstract Despite significant recent therapeutic advances, complete mucosal healing remains a difficult treatment target for many patients with inflammatory bowel diseases (IBD) to achieve. Our review focuses on the translational concept of promoting resolution of inflammation and repair as a necessary adjunctive step to reach this goal. We explore the roles of inflammatory cell apoptosis and efferocytosis to promote resolution, the new knowledge of gut monocyte-macrophage populations and their secreted prorepair mediators, and the processes of gut epithelial repair and regeneration to bridge this gap. We discuss the need and rationale for this vision and the tangible steps toward integrating proresolution therapies in IBD.

Mucosal Healing in Inflammatory Bowel Diseases

2015 ◽  
Vol 21 (1) ◽  
pp. 198-207 ◽  
Author(s):  
Annaïg Lan ◽  
François Blachier ◽  
Robert Benamouzig ◽  
Martin Beaumont ◽  
Christophe Barrat ◽  
...  
Keyword(s):  
Inflammatory Bowel Diseases ◽  
Mucosal Healing ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Noninvasive evaluation of mucosal healing in inflammatory bowel diseases

2012 ◽  
Vol 6 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Jun Kato ◽  
Sakiko Hiraoka ◽  
Asuka Nakarai ◽  
Masao Ichinose
Keyword(s):  
Inflammatory Bowel Diseases ◽  
Mucosal Healing ◽  
Noninvasive Evaluation ◽  
Bowel Diseases ◽  
Inflammatory Bowel
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