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Open-label, pilot protocol of patients with rheumatoid arthritis who switch to infliximab after an incomplete response to etanercept: The OPPOSITE study.
  1. Daniel E Furst (defurst{at}mednet.ucla.edu)
  1. University of California Los Angeles, United States
    1. Norman Gaylis (ngaylis{at}aol.com)
    1. Arthritis and Rheumatic Disease Specialties, United States
      1. Vance Bray (vbray{at}denverarthritisclinic.com)
      1. Denver Arthritis Clinic, United States
        1. Ewa Olech (ewa-olech{at}omrf.ouhsc.edu)
        1. Oklahoma University Health Sciences Center, United States
          1. David Yocum (dyocum{at}gene.com)
          1. University of Arizona Health Sciences Center, United States
            1. Jeffrey Ritter (crcdee{at}bellsouth.net)
            1. Center for Arthritis and Rheumatology, United States
              1. Michael Weisman (michael.weisman{at}cshs.org)
              1. Cedars-Sinai Medical Center, United States
                1. Daniel Wallace (wallace{at}beverlymed.com)
                1. Wallace Rheumatic Study Center, United States
                  1. John Crues (crues{at}radnetonline.com)
                  1. Pronet Imaging, United States
                    1. Dinesh Khanna (dinesh.khanna{at}uc.edu)
                    1. University of California Los Angeles, United States
                      1. Gregory Eckel (geckel{at}hotmail.com)
                      1. University of California Los Angeles, United States
                        1. Newman Yeilding (nyeildin{at}cntus.jnj.com)
                        1. Centocor, Inc., United States
                          1. Peter Callegari (pcallega{at}cntus.jnj.com)
                          1. Centocor, Inc., United States
                            1. Sudha Visvanathan (svisvana{at}cntus.jnj.com)
                            1. Centocor, Inc., United States
                              1. Jeannie Rojas (jrojas{at}cntus.jnj.com)
                              1. Centocor, Inc., United States
                                1. Ronald Hegedus (rhegedus{at}cntus.jnj.com)
                                1. Centocor, Inc., United States
                                  1. Laura George (lgeorge{at}cntus.jnj.com)
                                  1. Centocor, Inc., United States
                                    1. Khalid Mamun (kmamun{at}cntus.jnj.com)
                                    1. Centocor, Inc., United States
                                      1. Keith Gilmer (kgilmer{at}cntus.jnj.com)
                                      1. Centocor, Inc., United States
                                        1. Orrin Troum (otroum{at}yahoo.com)
                                        1. University of Southern California, United States

                                          Abstract

                                          Objectives:To incorporate a novel trial design to examine clinical response, cytokine expression, and joint imaging in rheumatoid arthritis patients switching from etanercept to infliximab.

                                          Methods:A randomized, open-label, clinical trial of 28 patients with an inadequate response to etanercept. Eligible patients remained on background methotrexate and were randomized 1:1 to discontinue etanercept and receive infliximab 3 mg/kg at weeks 0, 2, 6, 14, and 22 or continue etanercept 25 mg twice weekly. Data were analyzed for clinical response, serum biomarker levels, radiographic progression, MRI, and adverse events.

                                          Results:At week 16, 62% of infliximab-treated patients achieved 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 observed in patients receiving etanercept. ACR20 and ACR50 responses correlated at least minimally with intracellular adhesion molecule-1 and IL-8 in patients receiving infliximab. Thirty-eight percent of patients who were switched to infliximab showed reductions in health assessment questionnaire scores (>0.4) compared with 0% of etanercept patients. 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 randomized to continue 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 favoring patients switched to infliximab, therefore warranting further study with a more rigorous design.

                                          • comparative trial
                                          • etanercept
                                          • infliximab
                                          • rheumatoid arthritis

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