title: Patient-reported outcomes improve with etanercept plus methotrexate in active early rheumatoid arthritis and the improvement is strongly associated with remission: the COMET trial.
abstract: OBJECTIVE
  To compare the effects of etanercept (ETN) 50 mg once weekly plus methotrexate (MTX) versus MTX alone on patient-reported outcomes (PROs) and the relationship between remission and PRO improvement.
  
  
  METHODS
  In this double-blind, randomised clinical trial (COMET), PROs included: the Health Assessment Questionnaire (HAQ), EuroQoL health status, fatigue and pain visual analogue scales, Hospital Anxiety and Depression Scale, and Medical Outcomes Short-Form-36. Mean changes from baseline were analysed by analysis of covariance using the last observation carried forward method. Results from week 52 are presented.
  
  
  RESULTS
  Most PROs demonstrated significantly greater improvements with ETN+MTX than MTX alone, including physical functioning, pain, fatigue and overall health status. A significantly greater improvement in HAQ score was observed in the ETN+MTX than the MTX group (-1.02 vs -0.72; p<0.001) and a greater proportion reached the minimal clinically important difference of 0.22 (88% vs 78%; p<0.006). The relationship between PRO score and clinical status indicated that improvement was greatest among patients achieving remission.
  
  
  CONCLUSIONS
  Early treatment with ETN+MTX leads to significantly greater improvements in multiple dimensions of PROs than MTX alone. The close relationship between disease activity and PRO improvement suggests that early treatment, with remission as a goal, should maximise the chance of restoring normal functioning and HRQoL.
authors.affiliation: Clinic of Rheumatology, Vogelsang-Gommern, and University of Magdeburg, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Kekow
authors.forename: R J
authors.initials: RJ
authors.lastname: Moots
authors.forename: P
authors.initials: P
authors.lastname: Emery
authors.forename: P
authors.initials: P
authors.lastname: Durez
authors.forename: A
authors.initials: A
authors.lastname: Koenig
authors.forename: A
authors.initials: A
authors.lastname: Singh
authors.forename: R
authors.initials: R
authors.lastname: Pedersen
authors.forename: D
authors.initials: D
authors.lastname: Robertson
authors.forename: B
authors.initials: B
authors.lastname: Freundlich
authors.forename: R
authors.initials: R
authors.lastname: Sato
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept; D008727:Methotrexate