Seminars in Arthritis and Rheumatism
Volume 39, Issue 2 , Pages 123-131, October 2009

Treatment with Infliximab plus Methotrexate Improves Anemia in Patients with Rheumatoid Arthritis Independent of Improvement in Other Clinical Outcome Measures—A Pooled Analysis from Three Large, Multicenter, Double-Blind, Randomized Clinical Trials

  • Mittie K. Doyle, MD

      Affiliations

    • Associate Director, Immunology, Clinical Research and Development, Centocor Inc., Malvern, PA; Adj. Assistant Professor, University of Pennsylvania School of Medicine, Rheumatology, Philadelphia, PA
    • Corresponding Author InformationAddress reprints requests to: Mittie K. Doyle, MD, 200 Great Valley Parkway, Centocor, Inc., Malvern, PA 19355
    • ,
  • Mahboob U. Rahman, MD, PhD

      Affiliations

    • Senior Director Immunology, Clinical Research and Development, Centocor Research and Development, Inc., Malvern, PA; Adj. Associate Professor, University of Pennsylvania School of Medicine, Rheumatology, Philadelphia, PA
    • ,
  • Chenglong Han, PhD

      Affiliations

    • Associate Director, Health Economic Administration, Centocor Research and Development, Inc., Malvern, PA
    • ,
  • John Han, PhD

      Affiliations

    • Director, Biostatistics, Centocor Research and Development, Inc., Malvern, PA
    • ,
  • Jon Giles, MD

      Affiliations

    • Assistant Professor of Medicine, Division of Rheumatology, Johns Hopkins University, Baltimore, MD
    • ,
  • Clifton O. Bingham III, MD

      Affiliations

    • Assistant Professor of Medicine, Division of Rheumatology and Division of Allergy and Clinical Immunology, Johns Hopkins University, Baltimore, MD
    • ,
  • Joan Bathon, MD

      Affiliations

    • Director, Arthritis Center and Professor of Medicine, Division of Rheumatology, Johns Hopkins University, Baltimore, MD

published online 29 September 2008.

Objective

To evaluate the effect of antitumor necrosis factor-alpha monoclonal antibody infliximab treatment on anemia in patients with rheumatoid arthritis (RA).

Methods

Data from patients with RA who received infliximab or placebo in the multicenter, placebo-controlled, double-blind, randomized ATTRACT, ASPIRE, and START studies were included in this post-hoc, pooled analysis. Infliximab (3 to 10 mg/kg) was administered every 4 or 8 weeks, and all patients received stable doses of methotrexate (MTX). We determined the percentage of anemic patients (baseline hemoglobin level <12 g/dL) who had an increase from baseline in hemoglobin level greater than or equal to 1 or 2 g/dL or achieved normal hemoglobin level at week 22. The association of improvement in anemia with improvement in clinical parameters was also evaluated.

Results

Among patients with anemia at baseline, infliximab plus MTX treatment produced a significantly greater mean (standard deviation) increase in hemoglobin level from baseline to week 22 (0.74 [1.12], P < 0.0001) than placebo plus MTX (0.30 [0.92]). Significantly (P < 0.001) greater proportions of anemic patients treated with infliximab plus MTX had either at least a 1 g/dL (40%) or at least a 2 g/dL (12%) increase in hemoglobin level from baseline to week 22 or achieved normal hemoglobin level (43%) when compared with placebo plus MTX (19, 5, and 28%, respectively). Greater improvement in hemoglobin level among infliximab plus MTX-treated patients was consistently observed across subgroups and in patients without clinical response (American College of Rheumatology 20% response criteria) at week 22. Multiple regression analysis indicated that the effect of infliximab plus MTX on anemia was independent of improvement in disease activity.

Conclusion

Treatment with infliximab plus MTX significantly improved hemoglobin level among anemic RA patients when compared with treatment with placebo plus MTX, even after adjusting for improvement in disease activity.

Keywords: rheumatoid arthritis, anemia, chronic inflammation, anti-TNF

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 This research was supported by Centocor, Inc., Malvern, PA, USA, a subsidiary of Johnson & Johnson, New Brunswick, NJ. Drs. Doyle, Rahman, Han, and Han are employees of Centocor, Inc. and own stock in Johnson and Johnson. Drs. Giles, Bingham, and Bathon received consulting fees or research grants from Centocor, Inc.

PII: S0049-0172(08)00134-0

doi:10.1016/j.semarthrit.2008.08.002

Seminars in Arthritis and Rheumatism
Volume 39, Issue 2 , Pages 123-131, October 2009

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