Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population

J Am Acad Dermatol. 2012 Feb;66(2):e33-45. doi: 10.1016/j.jaad.2010.07.026. Epub 2010 Sep 17.


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.

Limitations: 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.

Conclusion: 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.

Trial registration: NCT00121615.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Drug-Related Side Effects and Adverse Reactions
  • Etanercept
  • Female
  • Humans
  • Immunoglobulin G / administration & dosage
  • Immunoglobulin G / adverse effects
  • Immunoglobulin G / therapeutic use*
  • Infections / etiology
  • Male
  • Middle Aged
  • Prospective Studies
  • Psoriasis / drug therapy*
  • Quality of Life
  • Receptors, Tumor Necrosis Factor / administration & dosage
  • Receptors, Tumor Necrosis Factor / therapeutic use*
  • Treatment Outcome


  • Immunoglobulin G
  • Receptors, Tumor Necrosis Factor
  • Etanercept

Associated data