title: Etanercept in combination with sulfasalazine, hydroxychloroquine, or gold in the treatment of rheumatoid arthritis.
abstract: OBJECTIVE
  To prospectively determine the efficacy and safety of etanercept in combination with sulfasalazine (SSZ), hydroxychloroquine (HCQ), and gold in the treatment of rheumatoid arthritis (RA).
  
  
  METHODS
  A prospective open-label study enrolled 119 patients with RA who had active disease despite stable therapy with SSZ (n = 50), HCQ (n = 50), or intramuscular gold (n = 19). Primary efficacy endpoints consisted of American College of Rheumatology responses at 24 and 48 weeks. Safety was established at regularly scheduled visits.
  
  
  RESULTS
  Patients in each etanercept combination showed significant improvement at both 24 and 48 weeks. Toxicity withdrawals by 48 weeks included gold (n = 1): proteinuria; HCQ (n = 5): septic wrist and bilateral pneumonia, rash, optic neuritis, breast cancer, squamous cancer of the tongue; and SSZ (n = 5): otitis media, elevated liver function indicators, pericarditis, rash, and gastroenteritis. The most common adverse events not requiring discontinuation from the study were injection site reactions (43% of patients) and upper respiratory type infections (34%).
  
  
  CONCLUSIONS
  This study is the first to prospectively evaluate the safety of etanercept in combination with SSZ, HCQ, and gold in patients with RA. Etanercept in combination with SSZ, HCQ, or gold was efficacious and well tolerated, with a discontinuation rate of 9% (11/119) for adverse events at 48 weeks.
authors.affiliation: Department of Internal Medicine, University of Nebraska Medical Center, Omaha, 983025, USA. jrodell@unmc.edu
authors.forename: James R
authors.initials: JR
authors.lastname: O'Dell
authors.forename: Kara
authors.initials: K
authors.lastname: Petersen
authors.forename: Robert
authors.initials: R
authors.lastname: Leff
authors.forename: William
authors.initials: W
authors.lastname: Palmer
authors.forename: Eric
authors.initials: E
authors.lastname: Schned
authors.forename: Kent
authors.initials: K
authors.lastname: Blakely
authors.forename: Claire
authors.initials: C
authors.lastname: Haire
authors.forename: Ana
authors.initials: A
authors.lastname: Fernandez
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000503:physiopathology; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D006046:Gold / Q000627:therapeutic use*; D006304:Health Status; D006801:Humans; D006886:Hydroxychloroquine / Q000627:therapeutic use*; D007074:Immunoglobulin G / Q000009:adverse effects*; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018124:Receptors, Tumor Necrosis Factor; D011993:Recombinant Fusion Proteins / Q000009:adverse effects*; D012720:Severity of Illness Index; D012460:Sulfasalazine / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D011993:Recombinant Fusion Proteins; D012460:Sulfasalazine; D006886:Hydroxychloroquine; D006046:Gold; D000068800:Etanercept