Casper Steenholdt1, Jørn Brynskov2, Ole Ø Thomsen2, Lars K Munck3, Lisbet A Christensen4, Gitte Pedersen5, Jens Kjeldsen6, Mark A Ainsworth2. 1. Department of Gastroenterology, Herlev Hospital, Herlev, Denmark steenholdt@dadlnet.dk. 2. Department of Gastroenterology, Herlev Hospital, Herlev, Denmark. 3. Department of Medical Gastroenterology, Køge Hospital, Køge, Denmark. 4. Deartment. of Hepatology and Gastroenterology V, Aarhus Hospital, Aarhus, Denmark. 5. Department of Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark. 6. Department of Medical Gastroenterology S, Odense Hospital, Odense, Denmark.
Abstract
BACKGROUND: This study assessed the effects of infliximab (IFX) treatment failure on patient-reported outcomes and explored the influence of using personalized treatment in this situation. METHODS:Sixty-nine Crohn's disease patients with IFX treatment failure were randomized to an intensified IFX regimen (n = 36) or personalized treatment defined by IFX and anti-IFX antibodies (n = 33). Health-related quality of life evaluated with the Short Inflammatory Bowel Disease Questionnaire (IBDQ) and productivity evaluated with the Work Productivity and Activity Impairment Questionnaire (WPAI:CD) were assessed at treatment failure and after 4, 8, 12 and 20 weeks. RESULTS:Median IBDQ score at manifestation of IFX treatment failure was 40 and improved markedly in responders by 11 at weeks 4 and 8 (p < 0.001) and by 13 at weeks 12 and 20 (p < 0.001). Non-responders improved modestly at weeks 12 and 20 (increase of median 4, p < 0.05). Overall activity impairment was high at IFX failure (median 70%) and decreased substantially in responders (40-50%, p < 0.001) and to a lesser extent in non-responders (15-40%, p < 0.05). In employed patients (55%), absenteeism was negligible during the entire study period. However, median presenteeism was 40% at manifestation of IFX failure and decreased only among responders across time (decrease 10-30%, p < 0.05). Although anti-tumour necrosis factor (TNF) therapy was discontinued in most patients handled by personalized treatment, IBDQ and WPAI:CD scores were similar in these patients compared with patients routinely dose-intensified on IFX. CONCLUSION: Regaining low disease activity after IFX failure is necessary for minimizing patient impairment and indirect disease-related costs. A personalized treatment strategy does not have a negative influence on patient-reported outcomes.
RCT Entities:
BACKGROUND: This study assessed the effects of infliximab (IFX) treatment failure on patient-reported outcomes and explored the influence of using personalized treatment in this situation. METHODS: Sixty-nine Crohn's diseasepatients with IFX treatment failure were randomized to an intensified IFX regimen (n = 36) or personalized treatment defined by IFX and anti-IFX antibodies (n = 33). Health-related quality of life evaluated with the Short Inflammatory Bowel Disease Questionnaire (IBDQ) and productivity evaluated with the Work Productivity and Activity Impairment Questionnaire (WPAI:CD) were assessed at treatment failure and after 4, 8, 12 and 20 weeks. RESULTS: Median IBDQ score at manifestation of IFX treatment failure was 40 and improved markedly in responders by 11 at weeks 4 and 8 (p < 0.001) and by 13 at weeks 12 and 20 (p < 0.001). Non-responders improved modestly at weeks 12 and 20 (increase of median 4, p < 0.05). Overall activity impairment was high at IFX failure (median 70%) and decreased substantially in responders (40-50%, p < 0.001) and to a lesser extent in non-responders (15-40%, p < 0.05). In employed patients (55%), absenteeism was negligible during the entire study period. However, median presenteeism was 40% at manifestation of IFX failure and decreased only among responders across time (decrease 10-30%, p < 0.05). Although anti-tumour necrosis factor (TNF) therapy was discontinued in most patients handled by personalized treatment, IBDQ and WPAI:CD scores were similar in these patients compared with patients routinely dose-intensified on IFX. CONCLUSION: Regaining low disease activity after IFX failure is necessary for minimizing patient impairment and indirect disease-related costs. A personalized treatment strategy does not have a negative influence on patient-reported outcomes.
Authors: Niels Teich; Michael Bläker; Frank Holtkamp-Endemann; Eric Jörgensen; Andreas Stallmach; Susanne Hohenberger Journal: Inflamm Intest Dis Date: 2020-12-18
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Authors: Rogério S Parra; Marley R Feitosa; Letícia C H Ribeiro; Lais A Castro; José J R Rocha; Omar Féres Journal: Gastroenterol Res Pract Date: 2018-05-08 Impact factor: 2.260
Authors: Åsa H Everhov; Michael C Sachs; Jonas F Ludvigsson; Hamed Khalili; Johan Askling; Martin Neovius; Pär Myrelid; Jonas Halfvarson; Caroline Nordenvall; Jonas Söderling; Ola Olén Journal: Clin Epidemiol Date: 2020-03-10 Impact factor: 4.790