title: One-year, multicenter, open-label, single-arm study evaluating the safety and effectiveness of etanercept for the treatment of moderate-to-severe plaque psoriasis in a Canadian population.
abstract: BACKGROUND
  Although etanercept is well tolerated and effective in moderate-to-severe plaque psoriasis, data are limited in Canadian practice settings.
  
  
  OBJECTIVE
  To assess the effectiveness and safety of etanercept in Canadian patients with moderate-to-severe plaque psoriasis (Physician Global Assessment [PGA] ≥ 3) in routine practice.
  
  
  METHODS
  A 1-year, multicenter, open-label trial of 246 patients enrolled from March 2006 to July 2009 was conducted. Patients received etanercept 50 mg subcutaneously twice weekly for 3 months and then 50 mg once weekly for 9 months. The primary end point was the proportion of patients achieving a PGA score ≤ 2 at month 12. Secondary end points included the proportion of patients achieving PGA score ≤ 2 at months 3, 6, and 9 and change from baseline at month 12 for Patient Global Assessment (PtGA), body surface area, and Dermatology Life Quality Index (DLQI). Adverse events were reported.
  
  
  RESULTS
  At month 12, 73.5% (95% CI 67.2-79.1) achieved a PGA score ≤ 2. The response was similar regardless of the previous response to systemic or phototherapy. The proportion of patients achieving this score improved from 2.2% (95% CI 0.3-4.2) at baseline to 73.5% (95% CI 67.2-79.1) at 12 months. At 12 months, patients with a DLQI score of 0 or ≥ 5-point improvement was 28.8% (95% CI 22.9-34.7) and 47.3% (95% CI 40.8-53.9), respectively. No new safety signals were reported.
  
  
  CONCLUSIONS
  The majority of this Canadian population demonstrated a meaningful improvement in PGA and DLQI scores over 1 year.
authors.affiliation: Dermatrials Research, Hamilton, ON.
authors.forename: Ronald
authors.initials: R
authors.lastname: Vender
authors.forename: Charles
authors.initials: C
authors.lastname: Lynde
authors.forename: Martin
authors.initials: M
authors.lastname: Gilbert
authors.forename: Vincent
authors.initials: V
authors.lastname: Ho
authors.forename: Sheetal
authors.initials: S
authors.lastname: Sapra
authors.forename: Melanie
authors.initials: M
authors.lastname: Poulin-Costello
mesh_terms: D000328:Adult; D002170:Canada; D016001:Confidence Intervals; D000068800:Etanercept; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use*; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009304:Nasopharyngitis / Q000139:chemically induced; D011565:Psoriasis / Q000188:drug therapy*; D011788:Quality of Life; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D012141:Respiratory Tract Infections / Q000139:chemically induced; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
chemical_list: D007074:Immunoglobulin G; D007155:Immunologic Factors; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept