Steenholdt, Casper5; Brynskov, Jørn6; Thomsen, Ole Østergaard6; Munck, Lars Kristian6; Fallingborg, Jan2; Christensen, Lisbet Ambrosius7; Pedersen, Gitte6; Kjeldsen, Jens6; Jacobsen, Bent Ascanius3; Oxholm, Anne Sophie6; Kjellberg, Jakob6; Bendtzen, Klaus6; Ainsworth, Mark Andrew6
1 The Faculty of Medicine, Aalborg University, VBN2 Aalborg University Hospital, The Faculty of Medicine, Aalborg University, VBN3 Klinik Medicin, The Faculty of Medicine, Aalborg University, VBN4 Medicinske Mave- og Tarmsygdomme (Gastroenterologi og Hepatologi), The Faculty of Medicine, Aalborg University, VBN5 Institut for Klinisk Medicin6 unknown7 Institut for Klinisk Medicin - Medicinsk afdeling V, NBG
a randomised, controlled trial
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.
Gut, 2014, Vol 63, Issue 6, p. 919-927
Adult; Aged; Aged, 80 and over; Algorithms; Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Monoclonal; Cost-Benefit Analysis; Crohn Disease; Denmark; Drug Tolerance; Female; Humans; Individualized Medicine; Intention to Treat Analysis; Male; Middle Aged; Severity of Illness Index; Single-Blind Method; Tumor Necrosis Factor-alpha; Young Adult; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't