Clinical study
Multicenter study of recombinant human erythropoietin in correction of anemia in rheumatoid arthritis☆,☆☆

https://doi.org/10.1016/0002-9343(90)90294-NGet rights and content

Abstract

purpse: To administer recombinant erythropoietin to patients with rheumatoid arthritis who had significant anemia, while monitoring hematologic and rheumatologic clinical responses as well as potential toxicity.

patients and methods: Seventeen patients with rheumatoid arthritis from five rheumatology care settings were studied. The patients had initial hematocrits of 34% or less and stable clinical status, and were not being treated with second-line drugs or corticosteroids. An 8-week randomized double-blind study involving various dosages of recombinant erythropoietin, as well as placebo, was followed by a 24-week open-label study in which dosage could be titrated to achieve a normal hematocrit.

results: In the 8-week randomized study, four of 13 patients who received injections of recombinant erythropoietin showed a hematologic response, arbitrarily defined as at least a 6-unit increase in hematocrit. None of four placebo-treated patients showed a meaningful hematologic response. All 11 patients who completed the subsequent 24-week open-label study reached a normal hematocrit level at some time during the study, and 10 of 11 showed an increase of hematocrit 6 units or greater. At least one adjustment, i.e., an increase, decrease, or omission of the erythropoietin dosage, was required in all patients to maintain the hematocrit at a target range of 35% for women or 40% for men. Meaningful changes were not seen in patients' capacity to perform activities of daily living or pain levels during either the 8-week randomized study or the 24-week open-label study. No adverse effects were associated with recombinant erythropoietin therapy.

conclusion: Patients with rheumatoid arthritis showed excellent hematologic responses to recombinant erythropoietin, without toxicity, during careful monitoring for appropriate dosage adjustment, although a meaningful change in rheumatologic clinical status was not seen.

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    ☆

    This study was supported by the Ortho Biotech Corporation, by Grants DK-1555, RR-95, and T32-07186 from the National Institutes of Health, the Jack C. Massey Foundation, and by Veterans Administration Medical Research Funds.

    ☆☆

    This study was presented in part at the annual meeting of the American College of Rheumatology, Houston, Texas, June 1988, and Cincinnati, Ohio, June 1989

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