title: Decreased pain and synovial inflammation after etanercept therapy in patients with reactive and undifferentiated arthritis: an open-label trial.
abstract: OBJECTIVE
  Elevated levels of tumor necrosis factor alpha (TNFalpha) have been identified in the synovium of patients with reactive and undifferentiated arthritis, implicating TNFalpha in the pathogenesis of these disorders. This finding has provided a rationale for the use of TNFalpha antagonists in the treatment of reactive arthritis; however, the possibility that the triggering microorganism might persist in affected joints and become activated with use of these agents has been of concern.
  
  
  METHODS
  The efficacy and safety of etanercept (25 mg subcutaneous twice weekly) in 16 patients with undifferentiated or reactive arthritis was assessed in a 6-month open-label trial. Synovial biopsies were performed before and after treatment with etanercept. Polymerase chain reaction (PCR) analysis was performed on the synovial biopsy samples to evaluate for the presence of nucleic acid material of bacterial organisms. Outcome measures including tender and swollen joint counts, pain assessment on a 10-point visual analog scale, and functional ability as measured by the Health Assessment Questionnaire were determined before and after etanercept therapy.
  
  
  RESULTS
  Ten of 16 patients completed the trial. Six patients withdrew, but none had a worsening of arthritis or infection. Of the 10 completers, 9 could be classified as treatment responders, despite the evidence of bacterial organisms on PCR analysis prior to initiating etanercept in 3 patients; 2 patients became PCR negative on etanercept. Five of 6 patients with adequate synovial biopsy specimens showed improvement, but not normalization of histology.
  
  
  CONCLUSIONS
  Etanercept was well-tolerated without clinical exacerbation of any suspected underlying infections and appeared to provide therapeutic benefit in our cohort of patients with reactive and undifferentiated arthritis.
authors.affiliation: University of Pennsylvania, VA Medical Centers, Philadelphia, Pennsylvania, USA.
authors.forename: Stephanie D
authors.initials: SD
authors.lastname: Flagg
authors.forename: Robert
authors.initials: R
authors.lastname: Meador
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Hsia
authors.forename: Tasanee
authors.initials: T
authors.lastname: Kitumnuaypong
authors.forename: H Ralph
authors.initials: HR
authors.lastname: Schumacher
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001168:Arthritis / Q000188:drug therapy* / Q000503:physiopathology; D016918:Arthritis, Reactive / Q000188:drug therapy* / Q000503:physiopathology; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000503:physiopathology*; D016133:Polymerase Chain Reaction; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D013585:Synovitis / Q000188:drug therapy
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept