Short-term trial of etanercept in Behçet's disease: a double blind, placebo controlled study

J Rheumatol. 2005 Jan;32(1):98-105.

Abstract

Objective: To determine the effect of the tumor necrosis factor-alpha blocker etanercept on the pathergy and monosodium urate (MSU) status and on the mucocutaneous and articular manifestations of patients with Behçet's disease (BD).

Methods: Forty male patients with BD, all with positive pathergy and MSU tests and mucocutaneous disease and/or arthritis, were randomized (20 patients to each study arm) to receive either etanercept 25 mg twice a week or placebo for 4 weeks. The pathergy and MSU responses and the frequencies of mucocutaneous and articular manifestations were compared between the 2 groups.

Results: There were no decreases in the pathergy and MSU responses in the etanercept group compared to the placebo group at any time. The mean numbers of oral ulcers, nodular lesions, and papulopustular lesions were less in the etanercept group compared to the placebo group at all weekly evaluations, except for the second week for papulopustular lesions. The probability of being free of oral ulcers and nodular lesions was also significantly higher in the former group (log-rank chi-square = 9.83, p = 0.0017; log-rank chi-square = 14.17, p = 0.0002, respectively).

Conclusion: Etanercept did not affect the pathergy reaction and the cutaneous response to MSU crystals. However, the drug was effective in suppressing most of the mucocutaneous manifestations of BD.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Behcet Syndrome / complications
  • Behcet Syndrome / drug therapy*
  • Behcet Syndrome / immunology
  • Double-Blind Method
  • Etanercept
  • Genital Diseases, Male / drug therapy
  • Genital Diseases, Male / etiology
  • Genital Diseases, Male / pathology
  • Humans
  • Immunoglobulin G / therapeutic use*
  • Immunosuppressive Agents / therapeutic use*
  • Inflammation / diagnosis
  • Male
  • Middle Aged
  • Mucous Membrane / pathology
  • Oral Ulcer / drug therapy
  • Oral Ulcer / etiology
  • Oral Ulcer / pathology
  • Placebos
  • Receptors, Tumor Necrosis Factor / therapeutic use*
  • Recombinant Fusion Proteins / therapeutic use*
  • Skin Diseases / etiology
  • Skin Diseases / pathology
  • Skin Tests
  • Treatment Outcome
  • Uric Acid

Substances

  • Immunoglobulin G
  • Immunosuppressive Agents
  • Placebos
  • Receptors, Tumor Necrosis Factor
  • Recombinant Fusion Proteins
  • Uric Acid
  • Etanercept