Monitoring by rheumatologists for methotrexate-, etanercept-, infliximab-, and anakinra-associated adverse events

Arthritis Rheum. 2003 Oct;48(10):2769-72. doi: 10.1002/art.11277.


Objective: To determine what monitoring protocols rheumatologists use to identify adverse events in rheumatoid arthritis (RA) patients treated with methotrexate (methotrexate), etanercept (etanercept), infliximab (infliximab), and anakinra (anakinra), how often rheumatologists encounter treatment-altering adverse events in their RA patients receiving these treatments, and how they feel about and comply with the current monitoring guidelines.

Methods: Three hundred ten physician members of the American College of Rheumatology (ACR) were notified by e-mail of a survey that was posted on our rheumatology Web site. Questions were closed-ended and multiple choice in format.

Results: One hundred twenty-three responses were received (40%). Most rheumatologists reported that they utilize the ACR recommended screening tests at baseline before methotrexate treatment is initiated. Seventy-nine percent reported that treatment-altering abnormalities had occurred in <5% of their methotrexate-treated RA patients, and 88% reported that such abnormalities had occurred in <10% of such patients, in the previous 3 years. Forty-one percent believed liver function monitoring guidelines need to be changed; 59% said they would agree with new guidelines that would include a recommendation for liver function monitoring every 3-4 months. Most rheumatologists were not aware of any guidelines for monitoring by blood tests in RA patients treated with biologic agents, yet the majority reported that they order blood tests before patients start these therapies and on followup.

Conclusion: Our survey indicates that treatment-altering liver function abnormalities in methotrexate-treated RA patients are rare, and more than half of rheumatologists agree that a less stringent monitoring regimen should be considered. Rheumatologists and pharmaceutical companies might work together to develop guidelines for monitoring of patients treated with biologic agents.

MeSH terms

  • Adverse Drug Reaction Reporting Systems*
  • Antibodies, Monoclonal / adverse effects
  • Antirheumatic Agents / adverse effects*
  • Arthritis, Rheumatoid / drug therapy*
  • Data Collection
  • Etanercept
  • Humans
  • Immunoglobulin G / adverse effects
  • Infliximab
  • Interleukin 1 Receptor Antagonist Protein
  • Methotrexate / adverse effects*
  • Practice Guidelines as Topic
  • Receptors, Tumor Necrosis Factor
  • Rheumatology / methods*
  • Rheumatology / standards
  • Sialoglycoproteins / adverse effects


  • Antibodies, Monoclonal
  • Antirheumatic Agents
  • IL1RN protein, human
  • Immunoglobulin G
  • Interleukin 1 Receptor Antagonist Protein
  • Receptors, Tumor Necrosis Factor
  • Sialoglycoproteins
  • Infliximab
  • Etanercept
  • Methotrexate