title: Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population.
abstract: BACKGROUND
  Etanercept is well tolerated and effective in moderate to severe plaque psoriasis. However, effectiveness and safety data beyond 2.5 years have not been reported.
  
  
  OBJECTIVE
  We sought to assess the effectiveness and safety profile of up to 4 years of etanercept therapy in psoriasis.
  
  
  METHODS
  We analyzed prospective data from previous trials and open-label extensions, including 506 patients who initiated etanercept therapy in either of two phase III trials. Patients received etanercept, 25 mg twice weekly, 50 mg weekly, or 50 mg twice weekly, depending on which trial therapy was started. Dosage adjustments were allowed in open-label extensions, but no patients exceeded 50 mg twice weekly. Outcomes included change from baseline for the static Physician Global Assessment and Dermatology Life Quality Index scores. Exposure-adjusted adverse event (AE) rates were calculated.
  
  
  RESULTS
  In all, 75.9% (95% confidence interval 67.9-84.0) and 27.8% (95% confidence interval 19.3-36.2) maintained Dermatology Life Quality Index response (≥ 5-point improvement from baseline) and static Physician Global Assessment response (clear or almost clear) at 48 months, respectively. AE and serious AE rates were 243.5 and 7.8 events per 100 patient-years, respectively. No serious AE rates exceeded 1.0 event per 100 patient-years. Overall infection and serious infection rates were 96.9 and 0.9 events per 100 patient-years, respectively. No cases of tuberculosis or lymphoma were reported.
  
  
  CONCLUSIONS
  Effectiveness data were limited to static Physician Global Assessment and Dermatology Life Quality Index scores. Analysis of AE rates was limited to available comparator databases.
  
  
  CONCLUSIONS
  Etanercept demonstrated sustained effectiveness and a favorable safety profile with no cumulative toxicity for up to 4 years, representing, to our knowledge, the longest published study on etanercept use in psoriasis to date.
authors.affiliation: Probity Medical Research, Waterloo, Ontario, Canada.
authors.forename: Kim A
authors.initials: KA
authors.lastname: Papp
authors.forename: Yves
authors.initials: Y
authors.lastname: Poulin
authors.forename: Robert
authors.initials: R
authors.lastname: Bissonnette
authors.forename: Marc
authors.initials: M
authors.lastname: Bourcier
authors.forename: Darryl
authors.initials: D
authors.lastname: Toth
authors.forename: Leslie
authors.initials: L
authors.lastname: Rosoph
authors.forename: Melanie
authors.initials: M
authors.lastname: Poulin-Costello
authors.forename: Mike
authors.initials: M
authors.lastname: Setterfield
authors.forename: Jerry
authors.initials: J
authors.lastname: Syrotuik
mesh_terms: D000328:Adult; D000368:Aged; D064420:Drug-Related Side Effects and Adverse Reactions; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007239:Infections / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011565:Psoriasis / Q000188:drug therapy*; D011788:Quality of Life; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept