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 Steenholdt, Jørn Brynskov, Ole Østergaard Thomsen, Lars Kristian Munck, Jan Fallingborg, Lisbet Ambrosius Christensen, Gitte Pedersen, Jens Kjeldsen, Bent Ascanius Jacobsen, Anne Sophie Oxholm, Jakob Kjellberg, Klaus Bendtzen, Mark Andrew Ainsworth

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

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.

Original languageEnglish
JournalGut
Volume63
Issue number6
Pages (from-to)919-927
ISSN0017-5749
DOIs
Publication statusPublished - 2014

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Crohn Disease
Randomized Controlled Trials
Single-Blind Method
Health Care Sector
Multicenter Studies
Cost-Benefit Analysis
Registries
Outpatients
Serum

Cite this

Steenholdt, Casper ; Brynskov, Jørn ; Thomsen, Ole Østergaard ; Munck, Lars Kristian ; Fallingborg, Jan ; Christensen, Lisbet Ambrosius ; Pedersen, Gitte ; Kjeldsen, Jens ; Jacobsen, Bent Ascanius ; Oxholm, Anne Sophie ; Kjellberg, Jakob ; Bendtzen, Klaus ; Ainsworth, Mark Andrew. / 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. In: Gut. 2014 ; Vol. 63, No. 6. pp. 919-927.
@article{415c3af4303043c487a9a056e0a28e14,
title = "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",
abstract = "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.",
author = "Casper Steenholdt and J{\o}rn Brynskov and Thomsen, {Ole {\O}stergaard} and Munck, {Lars Kristian} and Jan Fallingborg and Christensen, {Lisbet Ambrosius} and Gitte Pedersen and Jens Kjeldsen and Jacobsen, {Bent Ascanius} and Oxholm, {Anne Sophie} and Jakob Kjellberg and Klaus Bendtzen and Ainsworth, {Mark Andrew}",
year = "2014",
doi = "10.1136/gutjnl-2013-305279",
language = "English",
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Steenholdt, C, Brynskov, J, Thomsen, OØ, Munck, LK, Fallingborg, J, Christensen, LA, Pedersen, G, Kjeldsen, J, Jacobsen, BA, Oxholm, AS, Kjellberg, J, Bendtzen, K & Ainsworth, MA 2014, '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', Gut, vol. 63, no. 6, pp. 919-927. https://doi.org/10.1136/gutjnl-2013-305279

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. / Steenholdt, Casper; Brynskov, Jørn; Thomsen, Ole Østergaard; Munck, Lars Kristian; Fallingborg, Jan; Christensen, Lisbet Ambrosius; Pedersen, Gitte; Kjeldsen, Jens; Jacobsen, Bent Ascanius; Oxholm, Anne Sophie; Kjellberg, Jakob; Bendtzen, Klaus; Ainsworth, Mark Andrew.

In: Gut, Vol. 63, No. 6, 2014, p. 919-927.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Individualised therapy is more cost-effective than dose intensification in patients with Crohn's disease who lose response to anti-TNF treatment

T2 - a randomised, controlled trial

AU - Steenholdt, Casper

AU - Brynskov, Jørn

AU - Thomsen, Ole Østergaard

AU - Munck, Lars Kristian

AU - Fallingborg, Jan

AU - Christensen, Lisbet Ambrosius

AU - Pedersen, Gitte

AU - Kjeldsen, Jens

AU - Jacobsen, Bent Ascanius

AU - Oxholm, Anne Sophie

AU - Kjellberg, Jakob

AU - Bendtzen, Klaus

AU - Ainsworth, Mark Andrew

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

U2 - 10.1136/gutjnl-2013-305279

DO - 10.1136/gutjnl-2013-305279

M3 - Journal article

C2 - 23878167

VL - 63

SP - 919

EP - 927

JO - Gut

JF - Gut

SN - 0017-5749

IS - 6

ER -