Study on RA Patients who Switch to Infliximab After Etanercept

Multicenter Study

Open-label, pilot protocol of patients with rheumatoid arthritis who switch to infliximab after an incomplete response to etanercept: the opposite study

For the complete article in PDF format, please click here: full article

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.

This study was carried out at several centers:

Daniel E Furst ¹, Norman Gaylis ², Vance Bray ³, Ewa Olech ⁴, David Yocum ⁵, Jeffrey Ritter ⁶, Michael Weisman ⁷, Daniel J Wallace ⁸, John Crues ⁹, Dinesh Khanna ¹, Gregory Eckel ¹⁰, Newman Yeilding ¹¹, Peter Callegari ¹¹, Sudha Visvanathan ¹¹, Jeannie Rojas ¹¹, Ronald Hegedus ¹¹, Laura George ¹¹, Khalid Mamun ¹¹, Keith Gilmer ¹¹, Orrin Troum ¹²

¹ Division of Rheumatology, Department of Medicine, University of California Los Angeles, Los Angeles, California, USA
² Arthritis and Rheumatic Disease Specialties, Aventura, Florida, USA
³ Denver Arthritis Clinic, Denver, Colorado, USA
⁴ Oklahoma University Health Sciences Center, Oklahoma City, Oklahoma, USA
⁵ University of Arizona Health Sciences Center, Tucson, Arizona, USA
⁶ Center for Arthritis and Rheumatology, South Miami, Florida, USA
⁷ Cedars-Sinai Medical Center, Division of Rheumatology, Los Angeles, California, USA
⁸ Wallace Rheumatic Study Center, Los Angeles, California, USA
⁹ Pronet Imaging, Los Angeles, California, USA
¹⁰ Department of Radiological Sciences, University of California Los Angeles, Torrance, California, USA
¹¹ Centocor, Malvern, Pennsylvania, USA
¹² Keck School of Medicine, University of Southern California, Los Angeles, California, USA