title: 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.
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.
  
  
  CONCLUSIONS
  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.affiliation: Department of Gastroenterology, Herlev Hospital, Herlev, Denmark steenholdt@dadlnet.dk.
authors.forename: Casper
authors.initials: C
authors.lastname: Steenholdt
authors.affiliation: Department of Gastroenterology, Herlev Hospital, Herlev, Denmark.
authors.forename: Jørn
authors.initials: J
authors.lastname: Brynskov
authors.affiliation: Department of Gastroenterology, Herlev Hospital, Herlev, Denmark.
authors.forename: Ole Ø
authors.initials: OØ
authors.lastname: Thomsen
authors.affiliation: Department of Medical Gastroenterology, Køge Hospital, Køge, Denmark.
authors.forename: Lars K
authors.initials: LK
authors.lastname: Munck
authors.affiliation: Deartment. of Hepatology and Gastroenterology V, Aarhus Hospital, Aarhus, Denmark.
authors.forename: Lisbet A
authors.initials: LA
authors.lastname: Christensen
authors.affiliation: Department of Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark.
authors.forename: Gitte
authors.initials: G
authors.lastname: Pedersen
authors.affiliation: Department of Medical Gastroenterology S, Odense Hospital, Odense, Denmark.
authors.forename: Jens
authors.initials: J
authors.lastname: Kjeldsen
authors.affiliation: Department of Gastroenterology, Herlev Hospital, Herlev, Denmark.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Ainsworth
mesh_terms: D000041:Absenteeism; D000328:Adult; D003424:Crohn Disease / Q000188:drug therapy* / Q000191:economics; D004526:Efficiency; D005260:Female; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab / Q000627:therapeutic use*; D016014:Linear Models; D008297:Male; D000069597:Presenteeism / Q000706:statistics & numerical data; D011446:Prospective Studies; D011788:Quality of Life; D016037:Single-Blind Method; D017211:Treatment Failure; D014938:Work Capacity Evaluation
chemical_list: D005765:Gastrointestinal Agents; D000069285:Infliximab
keywords: IBD; activity; indirect costs; infliximab; loss of response; productivity; quality of life; work