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Most Trial Eligibility Criteria and Patient Baseline Characteristics Do Not Modify Treatment Effect in Trials Using

Anton Wulf Christensen1, Simon Tarp1, Daniel E Furst2

  • 1The Parker Institute, Department of Rheumatology, Copenhagen University Hospitals, Bispebjerg and Frederiksberg, Frederiksberg, Denmark.

Plos One
|September 12, 2015
PubMed
Abstract

Insights

Targeted therapies are effective for rheumatoid arthritis (RA). However, their added benefit is lower in DMARD-naïve patients and those with shorter disease durations, contrary to expectations for selective inclusion criteria.

Area of Science:

  • Rheumatology
  • Clinical Pharmacology
  • Epidemiology

Background:

  • Rheumatoid arthritis (RA) treatment response can be influenced by patient characteristics and trial eligibility.
  • Understanding these factors is crucial for optimizing targeted therapy efficacy.

Purpose of the Study:

  • To investigate if trial eligibility criteria and patient baseline characteristics modify the treatment response to targeted therapies in RA.
  • To identify potential effect modifiers for biological agents and targeted synthetic disease-modifying antirheumatic drugs (DMARDs).

Main Methods:

  • A meta-epidemiological study of 62 trials (19,923 RA patients) evaluating regulatory-approved targeted therapies for RA.
  • Analysis of ACR20 response rates at 3-6 months using Odds Ratios (ORs) and Ratio of Odds Ratios (ROR) to compare treatment effects across different criteria.

Main Results:

  • Targeted therapies demonstrated significant efficacy (OR 3.96).
  • Treatment benefit was lower in trials with "DMARD-naïve" patients (ROR=0.45) and "targeted therapy inadequate responders" (ROR=0.50).
  • Longer disease duration correlated with higher treatment response (OR per year=1.05).

Conclusions:

  • Highly selective patient inclusion in RA trials does not necessarily lead to greater treatment effects.
  • The efficacy of targeted therapies is reduced in DMARD-naïve patients and those with shorter disease durations.

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