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Oral Glucocorticoids for Skin Fibrosis in Early Diffuse Systemic Sclerosis: A Target Trial Emulation Study From the

Denis Mongin1, Marco Matucci-Cerinic2, Ulrich A Walker3

  • 1Geneva University Hospitals, Geneva, Switzerland.

Arthritis Care & Research
|November 14, 2024
PubMed
Abstract

Insights

Adding low-dose oral glucocorticoids to immunosuppression did not improve skin scores in early diffuse cutaneous systemic sclerosis (dcSSc). This treatment also did not increase the risk of scleroderma renal crisis, showing no significant benefit for skin fibrosis.

Area of Science:

  • Rheumatology
  • Immunology
  • Dermatology

Background:

  • Systemic sclerosis is a chronic autoimmune disease characterized by fibrosis.
  • Diffuse cutaneous systemic sclerosis (dcSSc) involves widespread skin thickening and internal organ involvement.
  • Optimal treatment for early dcSSc remains under investigation, balancing efficacy and safety.

Purpose of the Study:

  • To determine if adding oral glucocorticoids to immunosuppressive therapy improves skin scores in early dcSSc.
  • To assess the safety of combined therapy, specifically the risk of scleroderma renal crisis.

Main Methods:

  • An emulated randomized trial design was used, comparing patients with early dcSSc on immunosuppression with or without low-dose oral glucocorticoids (prednisone equivalent ≤20 mg/day).
  • The primary outcome was the change in modified Rodnan skin score (mRSS) at 12 ± 3 months.
  • Propensity score matching was employed to control for baseline differences between the treated and control groups.

Main Results:

  • A total of 208 patients were matched (104 per group), with comparable baseline characteristics.
  • No significant difference in the mean mRSS change was observed between the glucocorticoid-supplemented group and the control group (P = 0.64).
  • Secondary outcomes, including progressive fibrosis and scleroderma renal crisis, also showed no significant between-group differences.

Conclusions:

  • Adding low-dose oral glucocorticoids to standard immunosuppression does not provide significant benefit for skin fibrosis in early dcSSc.
  • The studied dosage of glucocorticoids did not elevate the risk of scleroderma renal crisis, indicating a favorable safety profile in this regard.

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