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

J Cutan Med Surg. 2013 Mar-Apr;17(2):129-38. doi: 10.2310/7750.2012.12036.

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.

Conclusion: The majority of this Canadian population demonstrated a meaningful improvement in PGA and DLQI scores over 1 year.

Publication types

  • Clinical Trial, Phase IV
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Canada
  • Confidence Intervals
  • Etanercept
  • Female
  • Headache / chemically induced
  • Humans
  • Immunoglobulin G / adverse effects
  • Immunoglobulin G / therapeutic use*
  • Immunologic Factors / adverse effects
  • Immunologic Factors / therapeutic use*
  • Male
  • Middle Aged
  • Nasopharyngitis / chemically induced
  • Psoriasis / drug therapy*
  • Quality of Life
  • Receptors, Tumor Necrosis Factor / therapeutic use*
  • Respiratory Tract Infections / chemically induced
  • Severity of Illness Index
  • Surveys and Questionnaires

Substances

  • Immunoglobulin G
  • Immunologic Factors
  • Receptors, Tumor Necrosis Factor
  • Etanercept