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Protocol development for combination therapy with disease-modifying antirheumatic drugs

H E Paulus1

  • 1School of Medicine, University of California, Los Angeles.

Seminars in Arthritis and Rheumatism
|October 1, 1993
PubMed
Summary
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Proving the effectiveness of combination disease-modifying antirheumatic drugs (DMARDs) is challenging. A strategic approach using pilot studies to identify promising combinations for larger trials is recommended.

Area of Science:

  • Rheumatology
  • Clinical Pharmacology
  • Drug Development

Background:

  • Evaluating combination disease-modifying antirheumatic drugs (DMARDs) for rheumatic diseases presents significant challenges.
  • Few combination therapies have been rigorously tested compared to monotherapy.

Purpose of the Study:

  • To propose a strategic framework for evaluating combination DMARD therapies.
  • To improve the success rate of identifying effective combination treatments.

Main Methods:

  • Emphasizes a phased approach starting with multiple small pilot studies.
  • Recommends careful patient selection, study design, duration, and outcome measure selection.
  • Suggests screening various combinations and dosages in initial studies.

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Main Results:

  • Currently, limited clinical trial data exists for combination DMARDs.
  • A systematic screening process can identify potentially superior combination therapies.

Conclusions:

  • A strategic protocol development using pilot studies is crucial for efficient evaluation of combination DMARDs.
  • Promising combinations identified in pilot studies should advance to large-scale, randomized pivotal trials for definitive efficacy assessment.