title: Treatment of rheumatoid arthritis with etanercept with reference to disease-modifying anti-rheumatic drugs: long-term safety and survival using prospective, observational data.
abstract: OBJECTIVE
  The objective of this study was to examine the long-term safety of etanercept (ETN) in comparison with conventional DMARDs in a large observational cohort of RA patients in the UK.
  
  
  METHODS
  Data were made available from the British Society of Rheumatology Biologics Register for a cohort of patients with RA treated with ETN and a reference cohort of RA patients treated with conventional DMARDs (maximum follow-up 10 years). The adjusted risk of events was compared using Cox proportional hazards models.
  
  
  RESULTS
  There were 3529 eligible ETN-treated patients (16,919 person-years) and 2864 conventional DMARD-treated patients (11,095 person-years), with notable differences between groups at baseline. Crude mortality rates were 12.0 vs 20.1 events per 1000 person-years for ETN and conventional DMARD patients, respectively, with an adjusted hazard ratio (aHR) of 0.72 (95% CI 0.54, 0.96). There was no difference in the long-term risk of serious infections (aHR = 1.02, 95% CI 0.83, 1.25). However, the risk was increased for ETN in the first 2 years (aHR = 1.56, 95% CI 1.16, 2.09; aHR = 1.32, 95% CI 1.06, 1.65). The aHRs (95% CIs) of various outcomes were cancer, 0.84 (0.68, 1.03); lymphoproliferative malignancy specifically, 0.51 (0.28, 0.95); all other serious adverse events, 0.70 (0.56, 0.87) and cardiac events specifically, 0.52 (0.37, 0.72).
  
  
  CONCLUSIONS
  There was no evidence of adverse outcome from long-term exposure to ETN. There was evidence of improved survival, reduced cardiovascular events and reduced lymphoproliferative malignancies.
authors.affiliation: Pharma Research Centre, Cardiff MediCentre, School of Medicine, Institute of Primary Care and Public Health, Cardiff University, Cardiff CF14 4UJ, UK. currie@cardiff.ac.uk.
authors.forename: Christopher Ll
authors.initials: CL
authors.lastname: Morgan
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.forename: Duncan
authors.initials: D
authors.lastname: Porter
authors.forename: Alan
authors.initials: A
authors.lastname: Reynolds
authors.forename: Adam
authors.initials: A
authors.lastname: Young
authors.forename: Helen
authors.initials: H
authors.lastname: Boyd
authors.forename: Chris D
authors.initials: CD
authors.lastname: Poole
authors.forename: Craig J
authors.initials: CJ
authors.lastname: Currie
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000401:mortality; D000068800:Etanercept; D005260:Female; D005500:Follow-Up Studies; D005544:Forecasting; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D006113:United Kingdom / Q000453:epidemiology
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D000068800:Etanercept
keywords: DMARDs (biologic); anti-TNF; outcomes research; rheumatoid arthritis; treatment