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      Evaluation of anti-TNF therapeutic response in patients with inflammatory bowel disease: Current and novel biomarkers

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          Abstract

          Neutralizing tumour necrosis factor (TNF) antibodies have been widely used to treat inflammatory bowel disease (IBD) in the clinical practice. In this review, the principal biomarker analysis revealed that faecal calprotectin, C-reactive protein, serum or mucosal concentrations of anti-TNF monoclonal antibodies (mAbs) and antibodies to anti-TNF mAbs are commonly used as current biomarkers in the evaluation of anti-TNF therapeutic efficacy. However, mucosal cytokine transcripts. microRNAs, proteomics and faecal and mucosal gut microbiota profile and mucosal histological features are reported to be novel candidates of biomarkers with high clinical utility in the evaluation of anti-TNF therapeutic efficacy in patients with IBD. Therefore, a robust validation of novel promising biomarkers and comparison studies between current used and novel biomarkers are urgently required to improve their value in the evaluation of therapeutic efficacy and optimization of personalized medicine and identification of IBD candidates for anti-TNF therapy in future clinical practice.

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          Epidemiology and risk factors for IBD.

          Ashwin Ananthakrishnan (2015)
          IBD, comprising Crohn's disease and ulcerative colitis, is a chronic immunologically mediated disease at the intersection of complex interactions between genetics, environment and gut microbiota. Established high-prevalence populations of IBD in North America and Europe experienced the steepest increase in incidence towards the second half of the twentieth century. Furthermore, populations previously considered 'low risk' (such as in Japan and India) are witnessing an increase in incidence. Potentially relevant environmental influences span the spectrum of life from mode of childbirth and early-life exposures (including breastfeeding and antibiotic exposure in infancy) to exposures later on in adulthood (including smoking, major life stressors, diet and lifestyle). Data support an association between smoking and Crohn's disease whereas smoking cessation, but not current smoking, is associated with an increased risk of ulcerative colitis. Dietary fibre (particularly fruits and vegetables), saturated fats, depression and impaired sleep, and low vitamin D levels have all been associated with incident IBD. Interventional studies assessing the effects of modifying these risk factors on natural history and patient outcomes are an important unmet need. In this Review, the changing epidemiology of IBD, mechanisms behind various environmental associations and interventional studies to modify risk factors and disease course are discussed.
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            Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial.

            Walter Reinisch, William J Sandborn, Daniel Hommes … (2011)
            The aim of this study was to assess the efficacy and safety of adalimumab (ADA), a recombinant human monoclonal antibody against tumour necrosis factor α (TNF), for the induction of clinical remission in anti-TNF naïve patients with moderately to severely active ulcerative colitis. This 8-week, multicentre, randomised, double-blind, placebo-controlled study (NCT00385736), conducted at 94 centres in North America and Europe, enrolled ambulatory adult patients with Mayo score of ≥ 6 points and endoscopic subscore of ≥ 2 points despite treatment with corticosteroids and/or immunosuppressants. Under the original study protocol, 186 patients were randomised (1:1) to subcutaneous treatment with ADA160/80 (160 mg at week 0, 80 mg at week 2, 40 mg at weeks 4 and 6) or placebo. Subsequently, at the request of European regulatory authorities, the protocol was amended to include a second induction group (ADA80/40: 80 mg at week 0, 40 mg at weeks 2, 4 and 6). The primary efficacy endpoint was clinical remission (Mayo score ≤ 2 with no individual subscore >1) at week 8, assessed in 390 patients randomised (1:1:1) to ADA160/80, ADA80/40, or placebo. Safety was assessed in all enrolled patients. Patients, study site personnel, investigators, and the sponsor were blinded to treatment assignment. At week 8, 18.5% of patients in the ADA160/80 group (p = 0.031 vs placebo) and 10.0% in the ADA80/40 group (p = 0.833 vs placebo) were in remission, compared with 9.2% in the placebo group. Serious adverse events occurred in 7.6%, 3.8% and 4.0% of patients in the placebo, ADA80/40, and ADA160/80 groups, respectively. There were two malignancies in the placebo group, none in the ADA groups. There were no cases of tuberculosis and no deaths. ADA160/80 was safe and effective for induction of clinical remission in patients with moderately to severely active ulcerative colitis failing treatment with corticosteroids and/or immunosuppressants. Clinical trial NCT00385736.
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              Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trial

              Jean-Frédéric Colombel, Remo Panaccione, Peter Bossuyt … (2018)
              Biomarkers of intestinal inflammation, such as faecal calprotectin and C-reactive protein, have been recommended for monitoring patients with Crohn's disease, but whether their use in treatment decisions improves outcomes is unknown. We aimed to compare endoscopic and clinical outcomes in patients with moderate to severe Crohn's disease who were managed with a tight control algorithm, using clinical symptoms and biomarkers, versus patients managed with a clinical management algorithm.
              Article 0 comments Cited 183 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Guanglin Cui
                Journal
                Journal ID (nlm-ta): EBioMedicine
                Journal ID (iso-abbrev): EBioMedicine
                Title: EBioMedicine
                Publisher: Elsevier
                ISSN (Electronic): 2352-3964
                Publication date PMC-release: 13 April 2021
                Publication date Collection: April 2021
                Publication date (Electronic): 13 April 2021
                Volume: 66
                Electronic Location Identifier: 103329
                Affiliations
                [a ]Research Group of Gastrointestinal Diseases, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou 450014, China
                [b ]Faculty of Health Science, Nord University, Campus Levanger, Norway
                [c ]Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou, China
                [d ]Division of Gastroenterology, Department of Internal Medicine, University Hospital of North Norway, Tromsø, Norway
                Author notes
                [* ]Corresponding author at: Faculty of Health Science, Nord University, Campus Levanger, Norway; or The Second Affiliated Hospital of Zhengzhou University, China. guanglin.cui@ 123456nord.no
                Article
                Publisher Item ID: S2352-3964(21)00122-5 Publisher ID: 103329
                DOI: 10.1016/j.ebiom.2021.103329
                PMC ID: 8054158
                PubMed ID: 33862588
                SO-VID: 9d5bf74c-899a-4a70-b745-ac91a17ad968
                Copyright © © 2021 The Authors
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 22 January 2021
                Date revision received : 18 March 2021
                Date accepted : 23 March 2021
                Categories
                Subject: Review

                Keywords: biomarker,inflammatory bowel disease,ulcerative colitis,crohn's disease,anti-tnf therapy
                Data availability:
                Keywords: biomarker, inflammatory bowel disease, ulcerative colitis, crohn's disease, anti-tnf therapy

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