Systemic sclerosis & Raynaud's
Oral Glucocorticoids for Skin Fibrosis in Early Diffuse Systemic Sclerosis: A Target Trial Emulation Study From the European Scleroderma Trials and Research Group Database
Authors' conclusion
We did not find any significant benefit of adding low-dose oral glucocorticoids to immunosuppression for skin fibrosis, and at this dosage, glucocorticoid did not increase the risk of scleroderma renal crisis.
Study context
- Population
- Patients with early diffuse cutaneous systemic sclerosis (dcSSc) from the EUSTAR database (mean age 49 years; 33% male; 59% anti-Scl70)matched
- Participants
- 208 patients
- Exposure
- Oral GC plus immunosuppression vs immunosuppression alone
- Treatedn = 104
- Controlsn = 104reference
- Outcome
- Change in mRSS from baseline
- Follow-up
- 12 ± 3 months
Methodological detailsobservational cohort, EUSTAR database, emulated randomized trial, propensity-score matched
- Observational cohort, EUSTAR database
- Emulated randomized trial
- Propensity-score matched
Main finding
As reported in the abstract
Mean mRSS change (decrease)
Treated
2.7
mean · 95% CI 1.4–4.0
Controls
3.1
mean · 95% CI 1.9–4.4
P = 0.64
Observational data: associations, not effects.
Secondary outcomes
mRSS change in shorter disease duration (≤ 24 months) or mRSS ≤22 (subgroups) · 12 ± 3 months
- Similar results observed
Progressive skin or lung fibrosis and scleroderma renal crisis (prespecified secondary outcomes)
- No between-group difference for all prespecified secondary outcomes
Safety
- A case of scleroderma renal crisis occurred in both groups
Original publication
Oral Glucocorticoids for Skin Fibrosis in Early Diffuse Systemic Sclerosis: A Target Trial Emulation Study From the European Scleroderma Trials and Research Group Database. Arthritis Care Res (Hoboken). Published 14 January 2025. doi:10.
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