Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/12548
Title: Crohn's disease management after intestinal resection: a randomised trial.
Austin Authors: De Cruz, Peter;Kamm, Michael A;Hamilton, Amy L;Ritchie, Kathryn J;Krejany, Efrosinia O;Gorelik, Alexandra;Liew, Danny;Prideaux, Lani;Lawrance, Ian C;Andrews, Jane M;Bampton, Peter A;Gibson, Peter R;Sparrow, Miles;Leong, Rupert W;Florin, Timothy H;Gearry, Richard B;Radford-Smith, Graham;Macrae, Finlay A;Debinski, Henry;Selby, Warwick;Kronborg, Ian;Johnston, Michael J;Woods, Rodney;Elliott, P Ross;Bell, Sally J;Brown, Steven J;Connell, William R;Desmond, Paul V
Affiliation: Department of Gastroenterology, Western Hospital, Melbourne, Victoria, Australia
AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Sydney, NSW, Australia
Melbourne Gastrointestinal Investigation Unit, Cabrini Hospital, Melbourne, Victoria, Australia
Department of Gastroenterology, St Vincent's Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
Melbourne EpiCentre, University of Melbourne and Melbourne Health, Melbourne, Victoria, Australia
Department of Gastroenterology, Alfred Health and Monash University, Melbourne, Victoria, Australia
Department of Colorectal Medicine and Genetics, and Department of Medicine, Royal Melbourne Hospital and University of Melbourne, Melbourne, Victoria, Australia
QIMR Berghofer Medical Research Institute, University of Queensland School of Medicine, Inflammatory Bowel Diseases Unit, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia
Department of Gastroenterology, Mater Health Services, University of Queensland, Brisbane, QLD, Australia
Austin Health, University of Melbourne, Austin Academic Centre, Heidelberg, Victoria, Australia
Department of Colorectal Surgery, St Vincent's Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
Department of Gastroenterology and Hepatology, Flinders Medical Centre and Flinders University, Adelaide, SA, Australia
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital and University of Adelaide, Adelaide, SA, Australia
Centre for Inflammatory Bowel Diseases, Fremantle Hospital and The University of Western Australia, Fremantle, WA, Australia
Department of Medicine, Imperial College London, London, UK
Gastroenterology and Liver Services, Concord and Bankstown Hospitals and The University of New South Wales, Sydney, NSW, Australia
Department of Gastroenterology, Alfred Health, Melbourne, Victoria, Australia
Department of Medicine, University of Otago, Christchurch, New Zealand.
Issue Date: 24-Dec-2014
Publication information: Lancet (london, England) 2014; 385(9976): 1406-17
Abstract: Most patients with Crohn's disease need an intestinal resection, but a majority will subsequently experience disease recurrence and require further surgery. This study aimed to identify the optimal strategy to prevent postoperative disease recurrence.In this randomised trial, consecutive patients from 17 centres in Australia and New Zealand undergoing intestinal resection of all macroscopic Crohn's disease, with an endoscopically accessible anastomosis, received 3 months of metronidazole therapy. Patients at high risk of recurrence also received a thiopurine, or adalimumab if they were intolerant to thiopurines. Patients were randomly assigned to parallel groups: colonoscopy at 6 months (active care) or no colonoscopy (standard care). We used computer-generated block randomisation to allocate patients in each centre to active or standard care in a 2:1 ratio. For endoscopic recurrence (Rutgeerts score ≥i2) at 6 months, patients stepped-up to thiopurine, fortnightly adalimumab with thiopurine, or weekly adalimumab. The primary endpoint was endoscopic recurrence at 18 months. Patients and treating physicians were aware of the patient's study group and treatment, but central reading of the endoscopic findings was undertaken blind to the study group and treatment. Analysis included all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT00989560.Between Oct 13, 2009, and Sept 28, 2011, 174 (83% high risk across both active and standard care groups) patients were enrolled and received at least one dose of study drug. Of 122 patients in the active care group, 47 (39%) stepped-up treatment. At 18 months, endoscopic recurrence occurred in 60 (49%) patients in the active care group and 35 (67%) patients in the standard care group (p=0.03). Complete mucosal normality was maintained in 27 (22%) of 122 patients in the active care group versus four (8%) in the standard care group (p=0.03). In the active care arm, of those with 6 months recurrence who stepped up treatment, 18 (38%) of 47 patients were in remission 12 months later; conversely, of those in remission at 6 months who did not change therapy recurrence occurred in 31 (41%) of 75 patients 12 months later. Smoking (odds ratio [OR] 2.4, 95% CI 1.2-4.8, p=0.02) and the presence of two or more clinical risk factors including smoking (OR 2.8, 95% CI 1.01-7.7, p=0.05) increased the risk of endoscopic recurrence. The incidence and type of adverse and severe adverse events did not differ significantly between patients in the active care and standard care groups (100 [82%] of 122 vs 45 [87%] of 52; p=0.51) and (33 [27%] of 122 vs 18 [35%] of 52; p=0.36), respectively.Treatment according to clinical risk of recurrence, with early colonoscopy and treatment step-up for recurrence, is better than conventional drug therapy alone for prevention of postoperative Crohn's disease recurrence. Selective immune suppression, adjusted for early recurrence, rather than routine use, leads to disease control in most patients. Clinical risk factors predict recurrence, but patients at low risk also need monitoring. Early remission does not preclude the need for ongoing monitoring.AbbVie, Gutsy Group, Gandel Philanthropy, Angior Foundation, Crohn's Colitis Australia, and the National Health and Medical Research Council.
Gov't Doc #: 25542620
URI: http://ahro.austin.org.au/austinjspui/handle/1/12548
DOI: 10.1016/S0140-6736(14)61908-5
URL: https://pubmed.ncbi.nlm.nih.gov/25542620
Type: Journal Article
Subjects: 6-Mercaptopurine.therapeutic use
Adult
Antibodies, Monoclonal, Humanized.administration & dosage
Azathioprine.therapeutic use
Colonoscopy
Crohn Disease.pathology.surgery.therapy
Female
Humans
Male
Metronidazole.therapeutic use
Middle Aged
Recurrence
Treatment Outcome
Appears in Collections:Journal articles

Show full item record

Page view(s)

8
checked on Nov 25, 2022

Google ScholarTM

Check


Items in AHRO are protected by copyright, with all rights reserved, unless otherwise indicated.