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      Canadian Association of Gastroenterology Clinical Practice Guideline for the Medical Management of Pediatric Luminal Crohn’s Disease

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          Abstract

          Background & Aims

          We aim to provide guidance for medical treatment of luminal Crohn’s disease in children.

          Methods

          We performed a systematic search of publication databases to identify studies of medical management of pediatric Crohn’s disease. Quality of evidence and strength of recommendations were rated according to the GRADE (Grading of Recommendation Assessment, Development, and Evaluation) approach. We developed statements through an iterative online platform and then finalized and voted on them.

          Results

          The consensus includes 25 statements focused on medical treatment options. Consensus was not reached, and no recommendations were made, for 14 additional statements, largely due to lack of evidence. The group suggested corticosteroid therapies (including budesonide for mild to moderate disease). The group suggested exclusive enteral nutrition for induction therapy and biologic tumor necrosis factor antagonists for induction and maintenance therapy at diagnosis or at early stages of severe disease, and for patients failed by steroid and immunosuppressant induction therapies. The group recommended against the use of oral 5-aminosalicylate for induction or maintenance therapy in patients with moderate disease, and recommended against thiopurines for induction therapy, corticosteroids for maintenance therapy, and cannabis in any role. The group was unable to clearly define the role of concomitant immunosuppressants during initiation therapy with a biologic agent, although thiopurine combinations are not recommended for male patients. No consensus was reached on the role of aminosalicylates in treatment of patients with mild disease, antibiotics or vedolizumab for induction or maintenance therapy, or methotrexate for induction therapy. Patients in clinical remission who are receiving immunomodulators should be assessed for mucosal healing within 1 year of treatment initiation.

          Conclusions

          Evidence-based medical treatment of Crohn’s disease in children is recommended, with thorough ongoing assessments to define treatment success.

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          Most cited references156

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          Ustekinumab induction and maintenance therapy in refractory Crohn's disease.

          William J Sandborn, Christopher R Gasink, Long-Long Gao … (2012)
          In patients with Crohn's disease, the efficacy of ustekinumab, a human monoclonal antibody against interleukin-12 and interleukin-23, is unknown. We evaluated ustekinumab in adults with moderate-to-severe Crohn's disease that was resistant to anti-tumor necrosis factor (TNF) treatment. During induction, 526 patients were randomly assigned to receive intravenous ustekinumab (at a dose of 1, 3, or 6 mg per kilogram of body weight) or placebo at week 0. During the maintenance phase, 145 patients who had a response to ustekinumab at 6 weeks underwent a second randomization to receive subcutaneous injections of ustekinumab (90 mg) or placebo at weeks 8 and 16. The primary end point was a clinical response at 6 weeks. The proportions of patients who reached the primary end point were 36.6%, 34.1%, and 39.7% for 1, 3, and 6 mg of ustekinumab per kilogram, respectively, as compared with 23.5% for placebo (P=0.005 for the comparison with the 6-mg group). The rate of clinical remission with the 6-mg dose did not differ significantly from the rate with placebo at 6 weeks. Maintenance therapy with ustekinumab, as compared with placebo, resulted in significantly increased rates of clinical remission (41.7% vs. 27.4%, P=0.03) and response (69.4% vs. 42.5%, P<0.001) at 22 weeks. Serious infections occurred in 7 patients (6 receiving ustekinumab) during induction and 11 patients (4 receiving ustekinumab) during maintenance. Basal-cell carcinoma developed in 1 patient receiving ustekinumab. Patients with moderate-to-severe Crohn's disease that was resistant to TNF antagonists had an increased rate of response to induction with ustekinumab, as compared with placebo. Patients with an initial response to ustekinumab had significantly increased rates of response and remission with ustekinumab as maintenance therapy. (Funded by Janssen Research and Development; CERTIFI ClinicalTrials.gov number, NCT00771667.).
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            The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults.

            Carlo A Fallone, Naoki Chiba, Sander van Zanten … (2016)
            Helicobacter pylori infection is increasingly difficult to treat. The purpose of these consensus statements is to provide a review of the literature and specific, updated recommendations for eradication therapy in adults.
            Article 0 comments Cited 304 times – based on 0 reviews     Review now
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              Mucosal healing in inflammatory bowel diseases: a systematic review.

              Markus F. Neurath, Simon P L Travis (2012)
              Recent studies have identified mucosal healing on endoscopy as a key prognostic parameter in the management of inflammatory bowel diseases (IBD), thus highlighting the role of endoscopy for monitoring of disease activity in IBD. In fact, mucosal healing has emerged as a key treatment goal in IBD that predicts sustained clinical remission and resection-free survival of patients. The structural basis of mucosal healing is an intact barrier function of the gut epithelium that prevents translocation of commensal bacteria into the mucosa and submucosa with subsequent immune cell activation. Thus, mucosal healing should be considered as an initial event in the suppression of inflammation of deeper layers of the bowel wall, rather than as a sign of complete healing of gut inflammation. In this systematic review, the clinical studies on mucosal healing are summarised and the effects of anti-inflammatory or immunosuppressive drugs such as 5-aminosalicylates, corticosteroids, azathioprine, ciclosporin and anti-TNF antibodies (adalimumab, certolizumab pegol, infliximab) on mucosal healing are discussed. Finally, the implications of mucosal healing for subsequent clinical management in patients with IBD are highlighted.
              Article 0 comments Cited 267 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Can Assoc Gastroenterol
                Journal ID (iso-abbrev): J Can Assoc Gastroenterol
                Journal ID (publisher-id): jcag
                Title: Journal of the Canadian Association of Gastroenterology
                Publisher: Oxford University Press (US )
                ISSN (Print): 2515-2084
                ISSN (Electronic): 2515-2092
                Publication date (Print): August 2019
                Publication date (Electronic): 10 July 2018
                Publication date PMC-release: 10 July 2018
                Volume: 2
                Issue: 3
                Pages: e35-e63
                Affiliations
                [1 ]Children’s Hospital of Eastern Ontario Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology and Nutrition, Children’s Hospital of Eastern Ontario, Ottawa, Ontario, Canada
                [2 ]Department of Pediatrics, University of Ottawa, Ottawa, Ontario, Canada
                [3 ]Ch.I.L.D. Foundation Canadian Children IBD Network, Vancouver, British Columbia, Canada
                [4 ]School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada
                [5 ]Faculty of Medicine, Memorial University, St John’s, Newfoundland and Labrador, Canada
                [6 ]Section of Pediatric Gastroenterology, Department of Pediatrics, Alberta Children’s Hospital, University of Calgary, Calgary, Alberta, Canada
                [7 ]Division of Gastroenterology and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada
                [8 ]IBD Centre, Department of Paediatrics, SickKids Hospital, University of Toronto, Toronto, Ontario, Canada
                [9 ]Department of Pediatric Gastroenterology, Hepatology, and Nutrition, Centre Hospitalier Universitaire, Sainte-Justine, Montréal, Quebec, Canada
                [10 ]Section of Pediatric Gastroenterology, Department of Pediatrics, Health Sciences Centre, Winnipeg, Manitoba, Canada
                [11 ]Department of Pediatrics (Gastroenterology), Stollery Children’s Hospital, Edmonton, Alberta, Canada
                [12 ]Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada
                [13 ]Division of Gastroenterology and Nutrition, IWK Health Centre, Halifax, Nova Scotia, Canada
                [14 ]Division of Pediatric Gastroenterology, McMaster University, Hamilton, Ontario, Canada
                [15 ]Division of Pediatric Gastroenterology, University of North Carolina, Hospital-Children’s Specialty Clinic, Chapel Hill, North Carolina
                [16 ]Division of Gastroenterology, Royal Alexandra Hospital, Edmonton, Alberta, Canada
                Article
                Publisher ID: gwz018
                DOI: 10.1093/jcag/gwz018
                PMC ID: 6619414
                PubMed ID: 31294379
                SO-VID: 72893099-f28b-4282-8e34-2a00785d4ede
                Copyright © © The Author(s) 2019. This article is being published jointly in the Journal of the Canadian Association of Gastroenterology and Clinical Gastroenterology and Hepatology by the Canadian Association of Gastroenterology and the AGA Institute
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                Page count
                Pages: 29
                Funding
                Funded by: AbbVie Corp
                Funded by: Canadian Institutes of Health Research Institute
                Funded by: Crohn’s and Colitis Canada
                Funded by: Takeda Canada Inc
                Funded by: Canadian Association of Gastroenterology 10.13039/501100000149
                Categories
                Subject: Clinical Practice Guidelines

                Keywords: grade,inflammatory bowel diseases,ibd,tnf
                Data availability:
                Keywords: grade, inflammatory bowel diseases, ibd, tnf

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