Individualised therapy is more cost-effective than dose intensification in patients with Crohn’s disease who lose response to anti-TNF treatment: a randomised, controlled trial
- Casper Steenholdt1,
- Jørn Brynskov1,
- Ole Østergaard Thomsen1,
- Lars Kristian Munck2,
- Jan Fallingborg3,
- Lisbet Ambrosius Christensen4,
- Gitte Pedersen5,
- Jens Kjeldsen6,
- Bent Ascanius Jacobsen3,
- Anne Sophie Oxholm7,
- Jakob Kjellberg7,
- Klaus Bendtzen8,
- Mark Andrew Ainsworth1
- 1Department of Gastroenterology, Herlev Hospital, Herlev, Denmark
- 2Department of Medical Gastroenterology, Køge Hospital, Køge, Denmark
- 3Department of Medical Gastroenterology, Aalborg Hospital, Aalborg, Denmark
- 4Department of Hepatology and Gastroenterology V, Aarhus Hospital, Aarhus, Denmark
- 5Department of Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark
- 6Department of Medical Gastroenterology S, Odense Hospital, Odense, Denmark
- 7KORA, Danish Institute for Local and Regional Government Research, Copenhagen, Denmark
- 8Institute for Inflammation Research, University Hospital of Copenhagen, Rigshospitalet, Copenhagen, Denmark
- Correspondence to Casper Steenholdt, Department of Gastroenterology, Herlev Hospital, Herlev Ringvej 75, DK-2730 Herlev, Denmark;
- Received 14 May 2013
- Revised 3 July 2013
- Accepted 4 July 2013
- Published Online First 22 July 2013
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: €6038 vs €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 (€4062 vs €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.
Trial Registration No NCT00851565.