Low-dose steroids fail to improve skin fibrosis in early diffuse systemic sclerosis
Key takeaways:
- Patients showed no difference in skin fibrosis whether they were given low-dose oral glucocorticoids or not.
- One patient in each treatment group had scleroderma renal crisis.
Low doses of glucocorticoids added to immunosuppression yield no significant benefit for skin fibrosis in early diffuse cutaneous systemic sclerosis, according to data published in Arthritis Care & Research.
“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,” Michele Iudici, MD, PhD, MPH, of Geneva University Hospitals, in Switzerland, told Healio. “Given that a randomized controlled trial on this topic failed for insufficient patient accrual, we wanted to provide an answer to this question: Does adding low-dose corticosteroids to immunosuppression improve skin induration in early diffuse SSc patients?”
To answer that question, Iudici and colleagues conducted a target trial emulation using data from the European Scleroderma Trials and Research Group. The study included 208 adults with diffuse cutaneous systemic sclerosis of less than 5 years duration (mean age, 49 years; 33% men), split into two groups of 104. One group received immunosuppression alone while the other additionally received oral glucocorticoids equivalent to 20 mg prednisone or less per day. Patients in the glucocorticoid group received a median prednisone dose of 5 mg per day.
The two groups underwent 1:1 propensity score matching based on age, sex, disease duration and other prognostic variables. The primary outcome, assessed at 12 ± 3 months, was the average change from baseline in modified Rodnan skin score (mRSS) in each group.
According to the researchers, both groups demonstrated similar average change in mRSS, with a decrease of 2.7 (95% CI, 1.4-4) in the glucocorticoid group and 3.1 (95% CI, 1.9-4.4) in the immunosuppression-only group. There were similar results in analyses limited to patients with shorter disease duration (24 months or less) and lower skin fibrosis at baseline (mRSS score 22 or below).
“Our results suggest that adding low-dose corticosteroids to immunosuppression do not improve the skin fibrosis at 1 year,” Iudici said.
Scleroderma renal crisis occurred in two patients, one in each group. The data suggest there is no major risk for scleroderma renal crisis with low-dose prednisone in early diffuse cutaneous systemic sclerosis, but the study “may not have been sufficiently powered to answer” that question, the researchers wrote.
“Our findings question the utility of prescribing a low dose of these compounds for this indication, thus adding further knowledge to a debated subject,” Iudici and colleagues wrote. “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.
“However, the lack of an excess of renal complication in glucocorticoid-treated patients and clinical experience provide supports for these drugs to be used for symptom control while emphasizing the crucial need for monitoring early signs of kidney disfunction.”
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