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  • Cost-effectiveness of laparoscopic ileocaecal resection versus infliximab treatment of terminal ileitis in Crohn’s disease: the LIR!C Trial

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Inflammatory bowel disease
Original article
Cost-effectiveness of laparoscopic ileocaecal resection versus infliximab treatment of terminal ileitis in Crohn’s disease: the LIR!C Trial
  1. E Joline de Groof1,2,
  2. Toer W Stevens2,
  3. Emma J Eshuis2,
  4. Tjibbe J Gardenbroek1,
  5. Judith E Bosmans3,
  6. Hanneke van Dongen3,
  7. Bregje Mol1,
  8. Christianne J Buskens1,
  9. Pieter C F Stokkers4,
  10. Ailsa Hart5,6,
  11. Geert R D’Haens2,
  12. Willem A Bemelman1,
  13. Cyriel Y Ponsioen2
  14. on behalf of the LIR!C study group
    1. 1 Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
    2. 2 Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
    3. 3 Department of Health Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
    4. 4 Department of Gastroenterology and Hepatology, OLVG West, Amsterdam, The Netherlands
    5. 5 Faculty of Medicine, Department of Surgery & Cancer, APRG, Imperial College, London, UK
    6. 6 IBD Unit, St. Mark’s Hospital, London, UK
    1. Correspondence to Dr Willem A Bemelman, Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam 1012 WX, The Netherlands; w.a.bemelman{at}amc.uva.nl

    Abstract

    Objective Evaluate the cost-effectiveness of laparoscopic ileocaecal resection compared with infliximab in patients with ileocaecal Crohn’s disease failing conventional therapy.

    Design A multicentre randomised controlled trial was performed in 29 centres in The Netherlands and the UK. Adult patients with Crohn’s disease of the terminal ileum who failed >3 months of conventional immunomodulators or steroids without signs of critical strictures were randomised to laparoscopic ileocaecal resection or infliximab. Outcome measures included quality-adjusted life-years (QALYs) based on the EuroQol (EQ) 5D-3L Questionnaire and the Inflammatory Bowel Disease Questionnaire (IBDQ). Costs were measured from a societal perspective. Analyses were performed according to the intention-to-treat principle. Missing cost and effect data were imputed using multiple imputation. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated to show uncertainty.

    Results In total, 143 patients were randomised. Mean Crohn’s disease total direct healthcare costs per patient at 1 year were lower in the resection group compared with the infliximab group (mean difference €−8931; 95% CI €−12 087 to €−5097). Total societal costs in the resection group were lower than in the infliximab group, however not statistically significant (mean difference €−5729, 95% CI €−10 606 to €172). The probability of resection being cost-effective compared with infliximab was 0.96 at a willingness to pay (WTP) of €0 per QALY gained and per point improvement in IBDQ Score. This probability increased to 0.98 at a WTP of €20 000/QALY gained and 0.99 at a WTP of €500/point of improvement in IBDQ Score.

    Conclusion Laparoscopic ileocaecal resection is a cost-effective treatment option compared with infliximab.

    Clinical trial registration number Dutch Trial Registry NTR1150; EudraCT number 2007-005042-20 (closed on 14 October 2015).

    • Crohn’s disease
    • laparoscopic ileocecal resection
    • infliximab
    • economic evaluation

    https://doi.org/10.1136/gutjnl-2018-317539

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      Footnotes

      • EJG and TWS contributed equally.

      • WAB and CYP contributed equally.

      • Contributors Guarantor of the article: EJdG and TS. Development of study concept and design: EJE, PCFS, WAB and CYP. Acquisition of data: EJdG, EJE, TJG and BM collected the data. Analysis and interpretation of data: EJdG, TS, JEB, HD, CB, WAB and CYP. Statistical analysis: JEB and HD. Drafting of manuscript: EJdG, TS, JEB, HD, WAB and CYP. Critical revision of the manuscript for important intellectual content: all authors.

      • Funding This study was financially supported by a grant from The Netherlands Organisation for Health Research and Development. The funder had no role in the conduct and interpretation of the trial.

      • Competing interests EJdG, TS, JEB, HvD, EJE, TJG, BM, CB, PCFS and WAB declare no conflict of interest. CYP declares a grant from Takeda, Dr Falk Pharma and Abbvie, advisory board fees from Takeda and GSK, as well as speaker’s fees from Takeda, Abbvie, Ferring, MSD and Dr. Falk Pharma. GRAMD’H has served as advisor for Abbvie, Ablynx, Amakem, AM Pharma, Avaxia, Biogen, Bristol Meiers Squibb, Boerhinger Ingelheim, Celgene, Celltrion, Cosmo, Covidien/Medtronics, Ferring, DrFalk Pharma, Engene, Galapagos, Genentech/Roche, Gilead, Glaxo Smith Kline, Hospira, Immunic, Johnson and Johnson, Lycera, Medimetrics, Millenium/Takeda, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Novonordisk, Otsuka, Pfizer, Prometheus laboratories/Nestle, Protagonist, Receptos, Robarts Clinical Trials, Salix, Sandoz, Setpoint, Shire, Teva, Tigenix, Tillotts, Topivert, Versant and Vifor and received speaker fees from Abbvie, Biogen, Ferring, Johnson and Johnson, Merck Sharp Dome, Mundipharma, Norgine, Pfizer, Shire, Millenium/Takeda, Tillotts and Vifor. AH declares an advisory board fee from MSD.

      • Patient consent Not required.

      • Ethics approval The medical ethics committee at the Amsterdam UMC, location Meibergdreef 9, Amsterdam, Netherlands and the corresponding committees in all participating centres in the Netherlands and the UK.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Collaborators LIRIC study group: Janindra Warusavitarne; Ad A Van Bodegraven; Menno A Brink; Esther CJ Consten; Bart A Van Wagensveld; Marno CM Rijk; Rogier MPH Crolla; Casper G Noomen; Alexander PJ Houdijk; Rosalie C Mallant; Maarten Boom; Willem A Marsman; Hein B Stockmann; A Jeroen De Groof; Karlien Bruin; John Maring; Theo van Ditzhuijsen; Hubert Prins; Jan van den Brande; Paul Kingma; Anna van Geloven; Nanne de Boer; Donald van der Peet; Jeroen Jansen; Michael Gerhards; Janneke van der Woude; Ruud Schouten; Bas Oldenburg; Richard van Hillegersberg; Rachel West; Guido Mannaerts; Marcel Spanier; Ernst Jan Spillenaar Bilgen; Rob Lieverse; Edwin van der Zaag; Annekatrien Depla; Arnold van de Laar; Clemens Bolwerk; Hans Brouwer; Nofel Mahmmod; Eric Hazebroek; Juda Vecht; Robert Pierik; Gerard Dijkstra; Sijbrand Hofker; Tessa Uiterwaal; Quirijn Eijsbouts; Liekele Oostenbrug; Meindert Sosef; Djuna Cahen; Sjoerd van der Werff; Andreas Marinelli; Job Peters; Huib Cense; Nynke Talstra; Pritesh Morar.