Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: retrospective long-term follow-up of the LIR!C trial

Autor: Jan van den Brande, Tessa Uiterwaal, Christianne J. Buskens, Juda Vecht, Robert E G J M Pierik, Job H.C. Peters, Nofel Mahmmod, John Maring, E. Joline de Groof, Toer W. Stevens, H. B. A. C. Stockmann, Pieter C. F. Stokkers, Karlien F. Bruin, Eric J. Hazebroek, Ailsa Hart, Arnold van de Laar, Hubert A Prins, Richard van Hillegersberg, Rachel L. West, Paul Kingma, Menno A. Brink, Pritesh Morar, Ruud Schouten, Marno C.M. Rijk, A Jeroen de Groof, Sijbrand Hofker, Annekatrien Depla, Bregje Mol, Janneke van der Woude, T. J. Gardenbroek, Janindra Warusavitarne, Bas Oldenburg, Edwin S. van der Zaag, Anna A. W. van Geloven, Rogier M P H Crolla, Emma J. Eshuis, Hans Brouwer, Meindert N. Sosef, Maria L Haasnoot, Geert R. D'Haens, Nynke Talstra, Marcel Spanier, Liekele Oostenbrug, Jeroen M. Jansen, Maarten J Boom, Donald L. van der Peet, Nanne K. H. de Boer, Willem A. Bemelman, Cyriel Y. Ponsioen, Rosalie C Mallant, Theo J.M. van Ditzhuijsen, Gerard Dijkstra, Alexander P.J. Houdijk, Willem A. Marsman, Djuna Cahen, Casper G. Noomen, Huib A. Cense, Esther C. J. Consten, Michael F. Gerhards, Ad A. van Bodegraven, Rob J. Lieverse, Andreas Marinelli, Sjoerd van der Werff, Clemens Bolwerk, Ernst Jan Spillenaar Bilgen, Quirijn A. J. Eijsbouts, Guido Mannaerts, Bart A. van Wagensveld
Přispěvatelé: ​Robotics and image-guided minimally-invasive surgery (ROBOTICS), Gastroenterology and hepatology, Surgery, AGEM - Digestive immunity, AII - Inflammatory diseases, Graduate School, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology, Paediatric Surgery
Rok vydání: 2020
Předmět:
Male
Cost-Benefit Analysis
Disease
Crohn Disease/etiology
law.invention
Laparoscopy/methods
0302 clinical medicine
Crohn Disease
Quality of life
Randomized controlled trial
Adrenal Cortex Hormones
law
Cost-Benefit Analysis/methods
Cecum
Crohn's disease
Hazard ratio
Gastroenterology
Middle Aged
Immunologic Factors/therapeutic use
Treatment Outcome
030220 oncology & carcinogenesis
Gastrointestinal Agents/therapeutic use
Female
030211 gastroenterology & hepatology
medicine.drug
Adult
medicine.medical_specialty
Terminal Ileitis
Adrenal Cortex Hormones/therapeutic use
Cecum/pathology
03 medical and health sciences
Gastrointestinal Agents
Ileum
medicine
Immunologic Factors
Humans
Retrospective Studies
Hepatology
Tumor Necrosis Factor-alpha
Tumor Necrosis Factor-alpha/antagonists & inhibitors
business.industry
Retrospective cohort study
medicine.disease
Ileum/pathology
Infliximab
Surgery
Infliximab/therapeutic use
Quality of Life
Laparoscopy
business
Follow-Up Studies
Zdroj: The lancet. Gastroenterology & hepatology, 5(10), 900-907. HANLEY & BELFUS-ELSEVIER INC
LIR!C study group 2020, ' Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease : retrospective long-term follow-up of the LIR!C trial ', The Lancet Gastroenterology and Hepatology, vol. 5, no. 10, pp. 900-907 . https://doi.org/10.1016/S2468-1253(20)30117-5
The Lancet Gastroenterology and Hepatology, 5(10), 900-907. Elsevier Ltd
lancet. Gastroenterology & hepatology, 5(10), 900-907. Elsevier Limited
ISSN: 2468-1253
Popis: BACKGROUND: The LIR!C trial showed that laparoscopic ileocaecal resection is a cost-effective treatment that has similar quality-of-life outcomes to treatment with infliximab, an anti-tumour necrosis factor (TNF) drug. We aimed to compare long-term outcomes of both interventions and identify baseline factors associated with the duration of treatment effect in each group.METHODS: In this retrospective follow-up study, we collected data from patients who participated in the LIR!C trial, a multicentre randomised controlled trial that compared quality of life after surgical resection versus infliximab in adult patients with non-stricturing and immunomodulator-refractory ileocaecal Crohn's disease. From Jan 1 to May 1, 2018, we collected follow-up data from the time from enrolment in the LIR!C trial until the last visit at either the gastrointestinal surgeon or gastroenterologist. In this study, outcomes of interest were need for surgery or repeat surgery or anti-TNF therapy, duration of treatment effect, and identification of factors associated with the duration of treatment effect. Duration of treatment effect was defined as the time without need for additional Crohn's disease-related treatment (corticosteroids, immunomodulators, biologics, or surgery).FINDINGS: We collected long-term follow-up data for 134 (94%) of 143 patients included in the LIR!C trial, of whom 69 were in the resection group and 65 were in the infliximab group. Median follow-up was 63·5 months (IQR 39·0-94·5). In the resection group, 18 (26%) of 69 patients started anti-TNF therapy and none required a second resection. 29 (42%) patients in the resection group did not require additional Crohn's disease-related medication, although 14 (48%) of these patients were given prophylactic immunomodulator therapy. In the infliximab group, 31 (48%) of 65 patients had a Crohn's disease-related resection, and the remaining 34 patients maintained, switched, or escalated their anti-TNF therapy. Duration of treatment effect was similar in both groups, with a median time without additional Crohn's disease-related treatment of 33·0 months (95% CI 15·1-50·9) in the resection group and 34·0 months (0·0-69·3) in the infliximab group (log-rank p=0·52). In both groups, therapy with an immunomodulator, in addition to the allocated treatment, was associated with duration of treatment effect (hazard ratio for resection group 0·34 [95% CI 0·16-0·69] and for infliximab group 0·49 [0·26-0·93]).INTERPRETATION: These findings further support laparoscopic ileocaecal resection as a treatment option in patients with Crohn's disease with limited (affected segment ≤40 cm) and predominantly inflammatory terminal ileitis for whom conventional treatment is not successful.FUNDING: None.
Databáze: OpenAIRE
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