title: Adalimumab improves patient-reported outcomes and reduces indirect costs in patients with moderate to severe Crohn's disease: results from the CARE trial.
abstract: OBJECTIVE
  Crohn's disease negatively affects patients' quality of life and ability to work. We investigated the impact of adalimumab on work productivity, daily activities, and quality of life in an open-label trial (N=945). The population comprised both infliximab-naïve and -exposed patients, including infliximab primary non-responders.
  
  
  METHODS
  Patients received adalimumab induction therapy (160 mg/80 mg at Weeks 0/2), followed by adalimumab 40 mg every other week for up to 20 weeks (patients with flares/non-response could receive 40 mg weekly at/after Week 12). The Work Productivity and Activity Impairment Questionnaire and Short Inflammatory Bowel Disease Questionnaire were assessed. Indirect cost savings were estimated based on the average work productivity improvements at Week 20.
  
  
  RESULTS
  Mean baseline scores indicated severe productivity impairment and poor quality of life. At Week 20, 60% of infliximab-naïve and 47% of infliximab primary non-responders achieved clinically important improvements (≥9 points) on the Short Inflammatory Bowel Disease Questionnaire, and 51% and 43%, respectively, achieved the minimum clinically important difference (improvement ≥7 percentage points) for total work productivity impairment (non-responder imputation). At Week 20, 64% of infliximab-naïve and 55% of infliximab primary non-responders achieved clinically important improvements in total activity impairment. Estimated 20-week total indirect productivity-related cost savings were €3070 per infliximab-naïve patient and €2059 per infliximab-exposed patient.
  
  
  CONCLUSIONS
  Adalimumab therapy significantly improved work productivity and disease-specific quality of life for patients with moderate to severe Crohn's disease. Patients who failed prior infliximab therapy and patients naïve to infliximab benefited from adalimumab, with potentially greater benefits for infliximab-naïve patients (NCT00409617).
authors.affiliation: University of Liège and CHU, Liège, Belgium. Edouard.Louis@ulg.ac.be
authors.forename: Edouard
authors.initials: E
authors.lastname: Louis
authors.forename: Robert
authors.initials: R
authors.lastname: Löfberg
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
authors.forename: Anne
authors.initials: A
authors.lastname: Camez
authors.forename: Mei
authors.initials: M
authors.lastname: Yang
authors.forename: Paul F
authors.initials: PF
authors.lastname: Pollack
authors.forename: Naijun
authors.initials: N
authors.lastname: Chen
authors.forename: Jingdong
authors.initials: J
authors.lastname: Chao
authors.forename: Parvez M
authors.initials: PM
authors.lastname: Mulani
mesh_terms: D000203:Activities of Daily Living; D000068879:Adalimumab; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy* / Q000191:economics; D004526:Efficiency; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014937:Work / Q000191:economics*; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D000068879:Adalimumab