Background: The optimal therapeutic approach to ileocecal Crohn's disease (CD) remains unclear. The objective of the study was to compare infliximab with laparoscopic ileocecal resection in patients with thiopurine or steroid refractory recurrent CD of the terminal ileum, with respect to quality of life (QoL) and cost-effectiveness.
Methods: A multicentre randomised controlled, open-label trial was performed in 33 centres in The Netherlands and the UK. Adult patients with CD of the terminal ileum who failed >3 months of thiopurine treatment or steroids without signs of a critical stricture were randomly allocated to either infliximab or laparoscopic ileocecal resection. Patients with a prior ileocecal resection, a diseased length >40 cm, abdominal abscesses or fluid collections or an American Society of Anaesthesiologists (ASA) score of III or IV were excluded. Primary outcomes were QoL measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) and costs per QALY at one year follow-up. The economic evaluation estimated the marginal direct medical, non-medical and time costs, costs per quality adjusted life year (QALY) and cost-utility ratio according to intention-to-treat analysis one year after initiation of treatment. Dutch Trial Registry NTR1150.
Results: Between May 2008 and October 2015, 143 patients were included (33% male) with a median age of 27 years (interquartile range 22–40). Eventually, 65 patients started with infliximab and 70 patients were operated. At time of submission, 98.6% of the patients have completed follow-up. At baseline, the mean difference (MD) in IBDQ score was 4.9 points in favour of the resection group. After correction for the baseline difference, the MD at one year was 5.8 points in favour of resection (95% confidence interval (CI) −4.7 to 16.3, p=0.28). A significant difference in favour of the resection group in QoL was observed with the SF-36 general health questionnaire, on the physical scale (MD 3.2, p=0.035) and the mental scale (MD 4.1, p=0.036). Mean direct total costs per patient at one year were €19,655 in the infliximab and €10,724 in the resection group (MD €−8,931, 95% CI: €−12,087 to €−5,097). One QALY gained in the resection group was associated with a societal costs reduction of €77,221. In the sensitivity analysis, 95% of CE-pairs were located in the south-east quadrant, confirming that laparoscopic ileocecal resection was on average less costly and more effective than infliximab.
Conclusions: Although QoL at one year was not significantly better with the IBDQ, laparoscopic ileocecal resection can be considered an acceptable alternative for infliximab. Surgery improved general quality of life and was associated with a reduction in costs compared to infliximab induction and maintenance therapy.