Glucocorticoid (GC) treatment can be successfully discontinued in some patients with inactive systemic sclerosis (SSc), especially those with less disability to begin with, according to Michele Iudici, Department of Clinical and Experimental Medicine, Rheumatology Section, Second University of Naples, Italy, and colleagues.
However, their study found that GC tapering is followed by disease-related inflammatory features in about a third of patients.
GC discontinuation has been studied in rheumatoid arthritis, vasculitis, and systemic lupus erythematosus, but this is not the case for SSc, which prompted the authors to investigate the issue.
The paper was published in Clinical Rheumatology.
The analysis included 48 adult patients with SSc, mean age 56 years and with a median disease duration of 10 years. The subjects had been taking oral glucocorticoids for more than a year, but had inactive disease and met various other criteria for disease control.
All patients were being treated with proton pump inhibitors, low-dose aspirin, calcium channel blockers, and vitamin D. Almost 44% were using other drugs in combination with GC.
The median daily dose of GC at study entry was 5 mg. All patients were taking prednisone.
Researchers assessed disease activity with the European Scleroderma Study Group index, and obtained a disease severity score from the Medsger scale. They also collected data on age, gender, mean daily dose of prednisone over the previous month, and duration of GC treatment.
Patients completed a visual analog scale (VAS) for pain and fatigue (scores range from 0 [none] to 100 mm [very severe]). They also completed a VAS for global health (GH) status that ranges from 0 (poorest) to 100 mm (the best).
In addition, patients filled out the Italian versions of the Short-Form 36 (SF-36) and the Health Assessment Questionnaire Disability Index (HAQ-DI).
At enrollment, the mean VAS scores were 42 mm for fatigue, 59 mm for general health, and 31 mm for pain. The median HAQ-DI score was 0.125. Impaired quality of life was recorded on the Physical Component Summary (median score 39.5) and Mental Component Summary (median score 43) of the SF-36.
After enrollment, researchers initiated a 6-month GC tapering schedule involving a reduction of 10% of the dose each week. When a daily 5-2.5 mg dose was reached, this was maintained for 3 weeks to minimize the risk of deprivation syndrome.
At month 6, or at the onset of any clinical manifestations requiring dosage change, patients were re-examined and they repeated the VAS assessments, and the SF-36 and HAQ-DI.
The study found that 69% of the patients were GC free at 6 months. Most of those unable to stop GC had an articular "flare," mainly arthralgia.
A multiple logistic analysis showed that a higher baseline HAQ-DI score was the only independent factor associated with GC need at month 6 (odds ratio [OR] 2.98; 95% CI 1.20-7.41; P= 0.01).
An analysis excluding patients who failed to achieve GC-free status for arthralgia, which can be a symptom of steroid withdrawal syndrome, still found that HAQ-DI was the only independent factor associated with GC need.
Since patients with a total score of 0.125 -- so with no or only mild difficulty in the HAQ-DI domains -- had the highest likelihood of becoming GC free, "we can assume that patients with the most severe disability are those with a more aggressive disease pattern who perhaps require heavier treatment," wrote the authors.
The HAQ-DI can be easily used in clinical practice to identify patients with a higher probability of stopping GC within 6 months, said the authors. But they added that it remains to be established whether patients with more severe disability would benefit from a slower tapering scheme.
One of the limitations of the study was the varied duration of GC intake among study subjects, which could have influenced response to discontinuation.
Asked to comment on the findings, Donald Miller, PharmD, of North Dakota State University in Fargo, said the findings are "not really" unexpected, but the study was important in that glucocorticoids are commonly used in SSc but there are no "well-done" studies on the best way to dose them or how to taper them.
"So anything that adds to the evidence-base for treating SSC is useful."
However, Miller added, the results are not likely to have a major impact on clinical practice. "The tapering regimen was fairly intuitive and similar to what most rheumatologists might do now. Also, the study only applies to patients with mild disease who had minimal symptoms at the time of beginning the taper."
Miller said the tapering regimen might have been better described. "I could not find the mean time to reach a zero dose of prednisone, or for how long successfully tapered patients were followed once they reached a zero dose."
He noted that there was no control group receiving an alternate regimen or even stable steroid doses. "So we can't tell how the patients might have fared with a different approach," he said.
A longer follow-up might also have been useful, said Miller.
The authors report no disclosures. Miller has no relevant conflicts of interest.
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