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 - 2014/6/1
Y1 - 2014/6/1
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.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Algorithms
KW - Anti-Inflammatory Agents, Non-Steroidal
KW - Antibodies, Monoclonal
KW - Cost-Benefit Analysis
KW - Crohn Disease
KW - Denmark
KW - Drug Tolerance
KW - Female
KW - Humans
KW - Individualized Medicine
KW - Intention to Treat Analysis
KW - Male
KW - Middle Aged
KW - Severity of Illness Index
KW - Single-Blind Method
KW - Tumor Necrosis Factor-alpha
KW - Young Adult
U2 - 10.1136/gutjnl-2013-305279
DO - 10.1136/gutjnl-2013-305279
M3 - Journal article
C2 - 23878167
SN - 0017-5749
VL - 63
SP - 919
EP - 927
JO - Gut
JF - Gut
IS - 6
ER -