Implications of Infliximab Treatment Failure and Influence of Personalized Treatment on Patient-reported Health-related Quality of Life and Productivity Outcomes in Crohn’s Disease

• Published in: Journal of Crohn's and colitis Vol. 9; no. 11; pp. 1032 - 1042
• Main Authors: Steenholdt, Casper, Brynskov, Jørn, Thomsen, Ole Ø., Munck, Lars K., Christensen, Lisbet A., Pedersen, Gitte, Kjeldsen, Jens, Ainsworth, Mark A.
• Format: Journal Article
• Language: English
• Published: UK Oxford University Press 01.11.2015
• Subjects: Absenteeism; Adult; Crohn Disease - drug therapy; Crohn Disease - economics; Efficiency; Female; Follow-Up Studies; Gastrointestinal Agents - therapeutic use; Humans; Infliximab - therapeutic use; Linear Models; Male; Presenteeism - statistics & numerical data; Prospective Studies; Quality of Life; Single-Blind Method; Treatment Failure; Work Capacity Evaluation; indirect costs; productivity; activity; infliximab; work; IBD; quality of life; loss of response
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1093/ecco-jcc/jjv139

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.