OBJECTIVE: The objective of this study is to evaluate whether adding oral glucocorticoids to immunosuppressive therapy improves skin scores and ensures safety in patients with early diffuse cutaneous systemic sclerosis (dcSSc). METHODS: We performed an emulated randomized trial comparing the changes from baseline to 12 ± 3 months of the modified Rodnan skin score (mRSS: primary outcome) in patients with early dcSSc receiving either oral glucocorticoids (≤20 mg/day prednisone equivalent) combined with immunosuppression (treated) or immunosuppression alone (controls), using data from the European Scleroderma Trials and Research Group. Secondary end points were the difference occurrence of progressive skin or lung fibrosis and scleroderma renal crisis. Matching propensity score was used to adjust for baseline imbalance between groups. RESULTS: We matched 208 patients (mean age 49 years; 33% male; 59% anti-Scl70), 104 in each treatment group, obtaining comparable characteristics at baseline. In the treated group, patients received a median prednisone dose of 5 mg/day. Mean mRSS change at 12 ± 3 months was similar in the two groups (decrease of 2.7 [95% confidence interval {95% CI} 1.4-4.0] in treated vs 3.1 [95% CI 1.9-4.4] in control, P = 0.64). Similar results were observed in patients with shorter disease duration (≤ 24 months) or with mRSS ≤22. There was no between-group difference for all prespecified secondary outcomes. A case of scleroderma renal crisis occurred in both groups. 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.

5 A Nasonova Research Institute of Rheumatology Russian Federation Moskow Russia

ASST Papa Giovanni XXIII Begamo Italy

Charité University Hospital Berlin Germany

Geneva University Hospitals Geneva Switzerland

Ghent University Ghent University Hospital and VIB Inflammation Research Center Ghent Belgium

Grigore T Popa University of Medicine and Pharmacy Iasi Rehabilitation Hospital Iasi Romania

Hospital Universitario Doctor Peset Valencia Spain

IRCCS San Raffaele Scientific Institute IRCCS San Raffaele Hospital and Vita Salute San Raffaele University Milan Italy

Istanbul Bilim University Altunizade Istanbul Turkey

Klinik Für Rheumatologie Und Klinische Immunologie Universitätsklinikum Schleswig Holstein Lübeck Germany

Leeds Institute of Rheumatic and Musculoskeletal Medicine University of Leeds Leeds United Kingdom

National Reference Center for Systemic Autoimmune Rare Diseases Bordeaux University Hospital Hôpital Pellegrin Bordeaux France

Radboud University Medical Center Nijmegen The Netherlands

University Hospital Basel Basel Switzerland

University Hospital Zurich Zurich Switzerland

University Prague Czech Republic

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