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Tumor necrosis factor antagonist responsiveness in a United States rheumatoid arthritis cohort

Jeffrey D Greenberg1, Mitsumasa Kishimoto, Vibeke Strand

  • 1New York University Hospital for Joint Diseases, New York, NY 10003, USA. Jeffrey.Greenberg@nyumc.org

The American Journal of Medicine
|May 27, 2008
PubMed
Abstract

Insights

Most rheumatoid arthritis patients receiving tumor necrosis factor (TNF) antagonists do not meet clinical trial criteria. Those meeting criteria show significantly better treatment response rates.

Area of Science:

  • Rheumatology
  • Clinical Trials
  • Immunology

Background:

  • Randomized controlled trials (RCTs) for tumor necrosis factor (TNF) antagonists define specific patient eligibility criteria.
  • Generalizability of RCT findings to real-world patient populations receiving TNF antagonists is often questioned.

Purpose of the Study:

  • To investigate clinical response rates in rheumatoid arthritis patients treated with TNF antagonists based on their adherence to RCT eligibility criteria.
  • To compare treatment responsiveness between patients who meet and do not meet established trial eligibility criteria.

Main Methods:

  • A multicentered US cohort of 465 biologic-naive rheumatoid arthritis patients prescribed TNF antagonists was analyzed.
  • Patients were stratified into two cohorts: Cohort A (n=336) met most criteria except acute phase reactants, and Cohort B (n=129) met all criteria.
  • Outcomes measured included modified American College of Rheumatology (ACR) 20% and 50% improvement responses.

Main Results:

  • A small percentage of patients (5.4%-19.4%) met the strict eligibility criteria of major TNF antagonist trials.
  • Patients meeting eligibility criteria in Cohort A achieved significantly higher ACR 20% (52.3%-63.6%) and ACR 50% (30.8%-45.5%) improvement rates.
  • Patients not meeting eligibility criteria demonstrated consistently inferior response rates (ACR 20%: 16.2%-20.4%; ACR 50%: 8.9%-10.8%) compared to those who did (P<.05).

Conclusions:

  • The majority of rheumatoid arthritis patients receiving TNF antagonists in a real-world setting do not meet typical clinical trial eligibility criteria.
  • Patients who meet trial eligibility criteria achieve superior clinical responses to TNF antagonists.
  • Findings underscore the challenge of balancing the need for well-defined treatment-responsive populations in trials with the goal of generalizing results to broader patient groups.

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