title: Open-label, pilot protocol of patients with rheumatoid arthritis who switch to infliximab after an incomplete response to etanercept: the opposite study.
abstract: OBJECTIVE
  To incorporate a new trial design to examine clinical response, cytokine expression and joint imaging in patients with rheumatoid arthritis (RA) switching from etanercept to infliximab treatment.
  
  
  METHODS
  A randomised, open-label, clinical trial of 28 patients with an inadequate response to etanercept was conducted. Eligible patients received background methotrexate and were randomised 1:1 to discontinue etanercept and receive infliximab 3 mg/kg at weeks 0, 2, 6, 14 and 22, or to continue etanercept 25 mg twice weekly. Data were analysed for clinical response, serum biomarker levels, radiographic progression, MRI and adverse events.
  
  
  RESULTS
  At week 16, 62% of infliximab-treated patients achieved American College of Rheumatology 20% criteria for improvement in RA (ACR20) responses compared with 29% of etanercept-treated patients. A 30.8% decrease from baseline in Disease Activity Score 28 was observed in patients receiving infliximab, compared with a 16.0% decrease in patients receiving etanercept. ACR20 and American College of Rheumatology 50% criteria for improvement in RA responses correlated at least minimally with intracellular adhesion molecule-1 and interleukin 8 in patients receiving infliximab. 38% of patients who were switched to infliximab showed reductions in Health Assessment Questionnaire scores (>0.4), compared with 0% of patients receiving etanercept. MRI analyses were inconclusive. Both drugs were well tolerated; 54% of infliximab-treated patients and 50% of etanercept-treated patients reported adverse events.
  
  
  CONCLUSIONS
  In this exploratory, open-label trial (with single-blind evaluator), patients were randomised to continue with etanercept or switch to infliximab. The small sample size of this hypothesis-generating study was underpowered to show statistical differences between groups. There was a numerical trend favouring patients who switched to infliximab, therefore warranting further study with a more rigorous design.
authors.affiliation: Division of Rheumatology, Department of Medicine, University of California Los Angeles, CA 90095-1670, USA. DEFurst@mednet.ucla.edu
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Furst
authors.forename: Norman
authors.initials: N
authors.lastname: Gaylis
authors.forename: Vance
authors.initials: V
authors.lastname: Bray
authors.forename: Ewa
authors.initials: E
authors.lastname: Olech
authors.forename: David
authors.initials: D
authors.lastname: Yocum
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Ritter
authors.forename: Michael
authors.initials: M
authors.lastname: Weisman
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Wallace
authors.forename: John
authors.initials: J
authors.lastname: Crues
authors.forename: Dinesh
authors.initials: D
authors.lastname: Khanna
authors.forename: Gregory
authors.initials: G
authors.lastname: Eckel
authors.forename: Newman
authors.initials: N
authors.lastname: Yeilding
authors.forename: Peter
authors.initials: P
authors.lastname: Callegari
authors.forename: Sudha
authors.initials: S
authors.lastname: Visvanathan
authors.forename: Jeannie
authors.initials: J
authors.lastname: Rojas
authors.forename: Ronald
authors.initials: R
authors.lastname: Hegedus
authors.forename: Laura
authors.initials: L
authors.lastname: George
authors.forename: Khalid
authors.initials: K
authors.lastname: Mamun
authors.forename: Keith
authors.initials: K
authors.lastname: Gilmer
authors.forename: Orrin
authors.initials: O
authors.lastname: Troum
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D015415:Biomarkers / Q000097:blood; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use*; D000069285:Infliximab; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011859:Radiography; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D015415:Biomarkers; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000069285:Infliximab; D000068800:Etanercept