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Corticosteroids--from an idea to clinical use
Ingrid E Lundberg1, Cecilia Grundtman, Esbjörn Larsson
1Rheumatology Unit, Department of Medicine at Karolinska Hospital, Karolinska Institutet, SE-171 76 Stockholm, Sweden. ingrid.lundberg@medks.ki.se
Best Practice & Research. Clinical Rheumatology
|May 5, 2004
Summary
Corticosteroids showed initial promise for rheumatoid arthritis (RA) but required a decade of research to prove superiority over aspirin. Study design and outcome measures influenced early trial results, highlighting the need for individualized patient criteria.
Area of Science:
- Rheumatology
- Pharmacology
- Clinical Trials
Background:
- Corticosteroids are foundational treatments for inflammatory rheumatic diseases, including rheumatoid arthritis (RA).
- Initial observations in 1949 by Hench and co-workers showed dramatic effects of corticosteroids in severe RA.
- Nobel Prize awarded in 1950 for adrenal cortex hormone discovery, fueling corticosteroid research.
Purpose of the Study:
- To review the historical development and comparative efficacy of corticosteroids in rheumatic diseases.
- To explore reasons for the delayed demonstration of corticosteroid superiority over aspirin in RA treatment.
- To discuss the impact of study design and outcome measures on early clinical trial interpretations.
Main Methods:
- Historical review of early corticosteroid trials in rheumatic diseases.
- Analysis of comparative studies between corticosteroids (cortisone, prednisolone) and aspirin for RA.
- Examination of study designs and outcome measures in pivotal trials.
Main Results:
- Early trials comparing cortisone to aspirin in RA showed no significant clinical benefit.
- A 1959 trial demonstrated significant improvement in functional capacity and well-being with prednisolone versus aspirin in early RA after two years.
- A ten-year gap existed between initial dramatic observations and definitive proof of corticosteroid superiority in controlled RA trials.
Conclusions:
- The delayed recognition of corticosteroid efficacy in RA compared to aspirin may be attributed to suboptimal study designs and outcome measures in early trials.
- Individualized response criteria could have yielded different results in initial comparative studies.
- Understanding these historical challenges is crucial for optimizing current and future clinical trial methodologies in rheumatology.