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Randomized Controlled Trial
. 2007 Jul;66(7):893-9.
doi: 10.1136/ard.2006.068304. Epub 2007 Apr 5.

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

Daniel E Furst  1 , Norman Gaylis, Vance Bray, Ewa Olech, David Yocum, Jeffrey Ritter, Michael Weisman, Daniel J Wallace, John Crues, Dinesh Khanna, Gregory Eckel, Newman Yeilding, Peter Callegari, Sudha Visvanathan, Jeannie Rojas, Ronald Hegedus, Laura George, Khalid Mamun, Keith Gilmer, Orrin Troum
Affiliations
Randomized Controlled Trial

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

Daniel E Furst et al. Ann Rheum Dis. 2007 Jul.

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.

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Conflict of interest statement

Competing interests: DEF received grants from Amgen, Abbott, Centocor, Genentech, Roche, NIH, Novartis, Genmab and Merck, and consulting fees from Amgen, Abbott, Genentech, Roche, NIH, Novartis and Merck. NG was a consultant at the time of the study for Centocor and MagneVu. VB received grants from Amgen and Centocor. EO received grants from Amgen, Bristol‐Myers Squibb, Centocor, F Hoffmann‐La Roche, Genentech, Human Genome Sciences, MedImmune, Otsuka America Pharmaceutical, speaking fees from Abbott, Centocor and MagneVu, and consulting fees from Abbott, Genentech and MagneVu. DY received grants and speaking fees from Centocor, Amgen and Abbott, and advising fees from Centocor. JR received consulting fees from Genentech and Biogenidec. MW received grants from Abbott, Actelion Pharmaceuticals, Amgen, Aspreva Pharmaceutical, BioRad Laboratories, Bristol Myers Squibb, Centocor, Genentech, Eli Lilly, Human Genome Sciences, Immunex, Immunomedics, Merck, Novartis, Pfizer, Procter and Gamble, Protein Design Labs, Sanofi Aventis, TAP Pharmaceuticals and Wyeth, and consulting fees from Abbott, Amgen, Bristol Myers, Elan Pharmaceuticals, Human Genome Sciences, Merck, Vertex Pharmaceuticals and Wyeth. DJW has no competing interests. J C owns stock in MagneVu. DK received grants from TAP Pharmaceuticals, speaking fees from Abbott, Wyeth, Amgen and Actelion Pharmaceuticals, and consulting fees from Centocor. GE has no competing interests. NY, PC, SV, JR, RH, LG, KM and KG are employees of Centocor. NY, SV, RH and LG own stock in Centocor. OT received grants, speaking fees and consulting fees from Centocor, Amgen and Wyeth.

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