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A Phase II randomized controlled trial of oral prednisolone in early diffuse cutaneous systemic sclerosis (PRedSS).
- Source :
-
Rheumatology . Sep2023, Vol. 62 Issue 9, p3133-3138. 6p. - Publication Year :
- 2023
-
Abstract
- Objectives Although the painful and disabling features of early diffuse cutaneous SSc (dcSSc) have an inflammatory basis and could respond to corticosteroids, corticosteroids are a risk factor for scleroderma renal crisis. Whether or not they should be prescribed is therefore highly contentious. Our aim was to examine safety and efficacy of moderate-dose prednisolone in early dcSSc. Methods PRedSS set out as a Phase II, multicentre, double-blind randomized controlled trial, converted to open-label during the Covid-19 pandemic. Patients were randomized to receive either prednisolone (∼0.3 mg/kg) or matching placebo (or no treatment during open-label) for 6 months. Co-primary endpoints were the HAQ Disability Index (HAQ-DI) and modified Rodnan skin score (mRSS) at 3 months. Over 20 secondary endpoints included patient reported outcome measures reflecting pain, itch, fatigue, anxiety and depression, and helplessness. Target recruitment was 72 patients. Results Thirty-five patients were randomized (17 prednisolone, 18 placebo/control). The adjusted mean difference between treatment groups at 3 months in HAQ-DI score was −0.10 (97.5% CI: −0.29, 0.10), P = 0.254, and in mRSS −3.90 (97.5% CI: −8.83, 1.03), P = 0.070, both favouring prednisolone but not significantly. Patients in the prednisolone group experienced significantly less pain (P = 0.027), anxiety (P = 0.018) and helplessness (P = 0.040) than control patients at 3 months. There were no renal crises, but sample size was small. Conclusion PRedSS was terminated early primarily due to the Covid-19 pandemic, and so was underpowered. Therefore, interpretation must be cautious and results considered inconclusive, indicating the need for a further randomized trial. Trial registration ClinicalTrials.gov , https://clinicaltrials.gov , NCT03708718. [ABSTRACT FROM AUTHOR]
- Subjects :
- *PREVENTION of mental depression
*DRUG efficacy
*RESEARCH
*PREDNISOLONE
*PAIN
*ORAL drug administration
*SYSTEMIC scleroderma
*HEALTH outcome assessment
*RANDOMIZED controlled trials
*BLIND experiment
*QUESTIONNAIRES
*RESEARCH funding
*ITCHING
*STATISTICAL sampling
*FATIGUE (Physiology)
*PATIENT safety
*LONGITUDINAL method
*PAIN management
*EVALUATION
ANXIETY prevention
Subjects
Details
- Language :
- English
- ISSN :
- 14620324
- Volume :
- 62
- Issue :
- 9
- Database :
- Academic Search Index
- Journal :
- Rheumatology
- Publication Type :
- Academic Journal
- Accession number :
- 171352465
- Full Text :
- https://doi.org/10.1093/rheumatology/kead012