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- Title
A Phase II randomized controlled trial of oral prednisolone in early diffuse cutaneous systemic sclerosis (PRedSS).
- Authors
Griffiths-Jones, Deborah J; Garcia, Yvonne Sylvestre; Ryder, W David; Pauling, John D; Hall, Frances; Lanyon, Peter; Bhat, Smita; Douglas, Karen; Gunawardena, Harsha; Akil, Mohammed; Anderson, Marina; Griffiths, Bridget; Galdo, Francesco Del; Youssef, Hazem; Madhok, Rajan; Arthurs, Barbara; Buch, Maya; Fligelstone, Kim; Zubair, Mohammed; Mason, Justin C
- 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.
- Subjects
PREVENTION of mental depression; ANXIETY prevention; 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
- Publication
Rheumatology, 2023, Vol 62, Issue 9, p3133
- ISSN
1462-0324
- Publication type
Article
- DOI
10.1093/rheumatology/kead012