Multicenter study of recombinant human erythropoietin in correction of anemia in rheumatoid arthritis

Am J Med. 1990 Aug;89(2):161-8. doi: 10.1016/0002-9343(90)90294-n.


Purpose: 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.

Publication types

  • Case Reports
  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Activities of Daily Living
  • Adult
  • Aged
  • Anemia / blood
  • Anemia / etiology
  • Anemia / therapy*
  • Arthritis, Rheumatoid / complications*
  • Double-Blind Method
  • Erythropoietin / therapeutic use*
  • Female
  • Ferritins / blood
  • Hematocrit
  • Humans
  • Male
  • Middle Aged
  • Monitoring, Physiologic
  • Multicenter Studies as Topic
  • Randomized Controlled Trials as Topic
  • Recombinant Proteins / therapeutic use


  • Recombinant Proteins
  • Erythropoietin
  • Ferritins