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Reporting and Extent of Glucocorticoid Use in Systemic Sclerosis Randomized Trials: A Meta-Research Study
Iulia-Simona Chirică1, Barbara Russo2, Michele Iudici3
1Department of Rheumatology, "Dr. Ion Cantacuzino'' Clinical Hospital, Bucharest, Romania; University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania.
Clinical Therapeutics
|April 4, 2026
Summary
Glucocorticoid use is common in systemic sclerosis clinical trials but poorly reported. Inadequate documentation of glucocorticoid (GC) use may bias results and complicate treatment effect interpretation.
Area of Science:
- Rheumatology
- Clinical Trials
- Pharmacology
Background:
- Systemic sclerosis (SSc) is a complex autoimmune disease.
- Glucocorticoids (GCs) are frequently used in SSc management.
- Randomized controlled trials (RCTs) are crucial for evaluating SSc treatments.
Purpose of the Study:
- To evaluate the prevalence of glucocorticoid (GC) use in SSc randomized controlled trials (RCTs).
- To assess the quality of reporting regarding GC utilization in SSc RCTs.
Main Methods:
- A systematic literature search of PubMed for SSc RCTs (2000-2024) investigating pharmacologic treatments.
- Extraction of trial characteristics, including planned and observed GC use.
- Summary of data using descriptive statistics.
Main Results:
- 76 SSc RCTs were included, primarily single-country and industry-funded.
- GC use was mentioned in 63.1% of studies, but details on allowance, dosage, and modification were often missing (65.7%, 65.8%, and 89.6% respectively).
- Baseline GC use data were incomplete in nearly half of the trials, with a median user proportion of 44.1%.
Conclusions:
- Glucocorticoid use is prevalent in SSc RCTs.
- Inadequate and variable reporting of GC utilization poses a risk of cointervention bias.
- Improved documentation of GC use is essential for accurate interpretation of SSc treatment trial outcomes.
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