title: Improved health outcomes with etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis.
abstract: BACKGROUND
  Patient reported outcomes (PROs) are especially useful in assessing treatments for rheumatoid arthritis (RA) since they measure dimensions of health-related quality of life that cannot be captured using strictly objective physiological measures. The aim of this study was to compare the effects of combination etanercept and methotrexate (ETN + MTX) versus combination synthetic disease modifying antirheumatic drugs (DMARDs) and methotrexate (DMARD + MTX) on PRO measures among RA patients from the Asia-Pacific region, a population not widely studied to date. Patients with established moderate to severe rheumatoid arthritis who had an inadequate response to methotrexate were studied.
  
  
  METHODS
  Patients were randomized to either ETN + MTX (N = 197) or DMARD + MTX (N = 103) in an open-label, active-comparator, multicenter study, with PRO measures designed as prospective secondary endpoints. The Health Assessment Questionnaire (HAQ), Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue), Medical Outcomes Short Form-36 Health Survey (SF-36), Hospital Anxiety and Depression Scale (HADS) and the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) were used.
  
  
  RESULTS
  Significantly greater improvements were noted for the ETN + MTX group at week16 for HAQ mean scores and for proportion of patients achieving HAQ score ≤ 0.5, compared to patients in the DMARD + MTX group. SF-36 Summary Scores for physical and mental components and for 6 of 8 health domains showed significantly greater improvements at week16 for the ETN + MTX group; only scores for physical functioning and role-emotional domains did not differ significantly between the two treatment arms. Greater improvements at week16 were noted for the ETN + MTX group for FACIT-Fatigue, HADS, and WPAI:GH mean scores.
  
  
  CONCLUSIONS
  Combination therapy using ETN + MTX demonstrated superior improvements using a comprehensive set of PRO measures, compared to combination therapy with usual standard of care DMARDs plus MTX in patients with established rheumatoid arthritis from the Asia-Pacific region.
  
  
  BACKGROUND
  clintrials.gov # NCT00422227.
authors.affiliation: Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul 133-792, Korea.
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Bae
authors.forename: Suk Chyn
authors.initials: SC
authors.lastname: Gun
authors.forename: Chi Chiu
authors.initials: CC
authors.lastname: Mok
authors.forename: Rezaul
authors.initials: R
authors.lastname: Khandker
authors.forename: Henk W
authors.initials: HW
authors.lastname: Nab
authors.forename: Andrew S
authors.initials: AS
authors.lastname: Koenig
authors.forename: Bonnie
authors.initials: B
authors.lastname: Vlahos
authors.forename: Ron
authors.initials: R
authors.lastname: Pedersen
authors.forename: Amitabh
authors.initials: A
authors.lastname: Singh
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology / Q000523:psychology; D001208:Asia / Q000453:epidemiology; D044466:Asian People / Q000523:psychology; D004185:Disability Evaluation; D004359:Drug Therapy, Combination; D004644:Emotions; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008603:Mental Health; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D020127:Recovery of Function; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept; D008727:Methotrexate