Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Treatment with Infliximab Improves Clinical Response and Physical Function in Patients with Moderate or Severe Rheumatoid Arthritis Actively Switch from Etanercept or Adalimumab Therapy.
Fleischmann8, Roy M., Goldman2, John A., Leirisalo-Repo4, Marjatta, Zanetakis7, Ellen I., El-Kadi1, Hisham S., Kellner6, Herbert L., Bolce3, Rebecca
Arthritis and Osteoporosis Association, Freehold, NJ
Atlanta Center for Clinical Research
Centocor Ortho Biotech Services, LLC
Helsinki University Central Hospital, Helsinki, Finland
Johnson and Johnson Pharmaceutical Research and Development, LLC
Medizinische Poliklinik/Munich University Hospital, Munchen, Germany
Oklahoma Center for Arthritis Therapy, Tulsa, OK
University of Texas SW Medical Center, Dallas, TX
Anecdotal evidence suggests that RA pts with active disease, despite tx with SC TNFa inhibitors, respond to infliximab (IFX). The dosing flexibility described in the IFX prescribing information allows for the tx of continued active disease by adjusting dose for achievement of specific targeted clinical outcomes.
To evaluate the safety & efficacy of IFX in RA pts with moderate or severe RA despite tx with etanercept (ETN) or adalimumab (ADA).
This is a Phase 4, multicenter, open-label, assessor-blinded, active switch study of IFX in pts with active RA who received MTX and had inadequate response (DAS28 score >= 3.6 and >= 6 swollen and >= 6 tender joints) to ETN or ADA. Pts were on stable dose of >= 7.5 mg/wk of MTX for >=4 wks prior to screening. Pts receiving ETN were switched no less than 1 wk and no more than 2 wks after the last dose; pts receiving ADA were switched no less than 2 wks and no more than 4wks after the last dose. Pts received open-label 3 mg/kg IFX infusions at wks 0, 2, and 6. Pts who either achieved/maintained EULAR response at wks 14 or 22 remained on current IFX dose. IFX dose was increased by 2 mg/kg for pts who did not achieve/lost response. EULAR response was evaluated at wk 10 post induction (primary endpoint) and following incremental increases in IFX dose in pts not adequately responding to the initial IFX doses. Physical function was assessed using HAQ.
Of the 203 pts enrolled, data for 197 were evaluable. 60.9% and 39.1% of pts were previously treated with ETN or ADA, respectively. Baseline demographics were reported previously.1 EULAR response was achieved by 49.7% of pts at wk 10 (55.6%, per protocol analysis) and 51.8% at wk 26 (61%, per protocol analysis) with/without dose adjustment. Among pts responsive to 3mg/kg induction dose, 45% maintained response through wk 26. ACR 20, 50, and 70 responses were achieved in 28.4%, 12.2 %, and 1.5% of pts at wk 10, respectively. These responses improved to 35.5% (ACR20), 18.3% (ACR50), and 7.1% (ACR70) at wk 26. Mean CDAI and SDAI were 40.1 and 41.2, respectively, at baseline and significantly improved to 21.45 (p< 0.001) and 22.28 (p<0.001), respectively, at wk 26. 48.3% of pts previously treated with ETN and 57.1% of pts previously treated with ADA achieved a EULAR response at wk 26. Changes from baseline at wk 10 and 26 in DAS 28, HAQ, SJC, and TJC are described (Table). At least 1 AE and serious AE were reported in 70.4% and 4.9% of pts, respectively; 6.9% of pts experienced at least 1 infusion reaction (1.6% of infusions were associated with an infusion reaction).
RA pts actively switched from tx with ETN or ADA to IFX, without a washout period, demonstrated a statistically significant and clinically important improvement in EULAR response and physical function. IFX was generally well-tolerated with no new safety signals observed.
Table. Summary of mean (SD) change from baseline at wks 10 and 26
To cite this abstract, please use the following information:
Fleischmann, Roy M., Goldman, John A., Leirisalo-Repo, Marjatta, Zanetakis, Ellen I., El-Kadi, Hisham S., Kellner, Herbert L., et al; Treatment with Infliximab Improves Clinical Response and Physical Function in Patients with Moderate or Severe Rheumatoid Arthritis Actively Switch from Etanercept or Adalimumab Therapy. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :420