A new study challenges the widespread use of glucocorticoids in systemic sclerosis treatment, finding no significant benefit in improving skin fibrosis when added to standard immunosuppression therapy. The research, published in Arthritis Care & Research, provides important insights for clinicians managing early diffuse cutaneous systemic sclerosis (dcSSc).
Study Design and Patient Population
Researchers from Geneva University Hospitals conducted a target trial emulation using data from the European Scleroderma Trials and Research Group. The study included 208 adults with dcSSc of less than 5 years duration, with a mean age of 49 years and 33% male participation. Participants were equally divided into two groups of 104 patients each, matched using 1:1 propensity score based on age, sex, disease duration, and other prognostic variables.
One group received immunosuppression therapy alone, while the other received additional oral glucocorticoids at doses equivalent to 20 mg prednisone or less daily, with a median dose of 5 mg per day. The primary outcome measure was the change in modified Rodnan skin score (mRSS) at 12 ± 3 months from baseline.
Key Findings and Outcomes
The results showed remarkably similar outcomes between both treatment groups. The glucocorticoid group demonstrated an average mRSS decrease of 2.7 points (95% CI, 1.4-4), while the immunosuppression-only group showed a decrease of 3.1 points (95% CI, 1.9-4.4). These findings remained consistent even in subgroup analyses of patients with shorter disease duration and lower baseline skin fibrosis.
"We know that the use of glucocorticoids in systemic sclerosis is widespread when there is no solid evidence supporting their use, as, for example, when we target skin fibrosis," explained Dr. Michele Iudici, the study's lead researcher.
Safety Considerations and Implications
The study documented one case of scleroderma renal crisis in each group, suggesting no major increased risk with low-dose glucocorticoids. However, researchers noted that the study might not have been sufficiently powered to definitively assess this safety aspect.
Future Research Directions
While the study questions the utility of low-dose glucocorticoids for skin fibrosis, researchers acknowledge that further investigation is needed to evaluate their potential benefits for other symptoms such as fatigue, pain, and itching. The findings emphasize the importance of evidence-based treatment decisions in systemic sclerosis management.
"Whether a short course of low-dose steroids could contribute to improve fatigue, pain and itching was not the object of the present study and remains to be further investigated," the research team noted, while emphasizing the continued need for careful monitoring of kidney function in patients receiving glucocorticoid treatment.
