期刊
GUT
卷 63, 期 6, 页码 919-927出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/gutjnl-2013-305279
关键词
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资金
- Aase and Ejnar Danielsen's Foundation
- Beckett Foundation
- Danish Biotechnology Program
- Danish Colitis-Crohn Society
- Danish Medical Association Research Foundation
- Frode V Nyegaard and Wife's Foundation
- Health Science Research Foundation of Region of Copenhagen
- Herlev Hospital Research Council
- Lundbeck Foundation
- P Carl Petersen's Foundation
- Ole Ostergaard Thomsen's Research Foundation
- Jorn Brynskov's Research Foundation
Objective Although the reasons for secondary loss of response to infliximab (IFX) maintenance therapy in Crohn's disease vary, dose intensification is usually recommended. This study investigated the cost-effectiveness of interventions defined by an algorithm designed to identify specific reasons for therapeutic failure. Design Randomised, controlled, single-blind, multicentre study. 69 patients with secondary IFX failure were randomised to IFX dose intensification (5 mg/kg every 4 weeks) (n=36) or interventions based on serum IFX and IFX antibody levels using the proposed algorithm (n=33). Predefined co-primary end points at week 12 were proportion of patients responding (Crohn's Disease Activity Index (CDAI) decrease >= 70, or >= 50% reduction in active fistulas) and accumulated costs related to treatment of Crohn's disease, expressed as mean cost per patient, based on the Danish National Patient Registry for all hospitalisation and outpatient costs in the Danish healthcare sector. Results Costs for intention-to-treat patients were substantially lower (34%) for those treated in accordance with the algorithm than by IFX dose intensification: epsilon 6038 vs epsilon 9178, p<0.001. However, disease control, as judged by response rates, was similar: 58% and 53%, respectively, p=0.81; difference 5% (-19% to 28%). For per-protocol patients, treatment costs were even lower (56%) in the algorithm-treated group (epsilon 4062 vs epsilon 9178, p<0.001) and with similar response rates (47% vs 53%, p=0.78; difference -5% (-33% to 22%)). Conclusions Treatment of secondary IFX failure using an algorithm based on combined IFX and IFX antibody measurements significantly reduces average treatment costs per patient compared with routine IFX dose escalation and without any apparent negative effect on clinical efficacy.
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