دورية أكاديمية
A Phase II randomized controlled trial of oral prednisolone in early diffuse cutaneous systemic sclerosis (PRedSS)
| العنوان: | A Phase II randomized controlled trial of oral prednisolone in early diffuse cutaneous systemic sclerosis (PRedSS) |
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| المؤلفون: | 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, Del Galdo, Francesco, Youssef, Hazem, Madhok, Rajan, Arthurs, Barbara, Buch, Maya, Fligelstone, Kim, Zubair, Mohammed, Mason, Justin C., Denton, Christopher P., Herrick, Ariane L. |
| المصدر: | Griffiths-Jones , D J , Garcia , Y S , Ryder , W D , Pauling , J D , Hall , F , Lanyon , P , Bhat , S , Douglas , K , Gunawardena , H , Akil , M , Anderson , M , Griffiths , B , Del Galdo , F , Youssef , H , Madhok , R , Arthurs , B , Buch , M , Fligelstone , K , Zubair , M , Mason , J C , Denton , C P & Herrick , A L 2023 , ' A .... |
| سنة النشر: | 2023 |
| المجموعة: | Discovery - University of Dundee Online Publications |
| مصطلحات موضوعية: | Systemic sclerosis, pain, disability, randomised controlled trial, corticosteroids, SSc, randomized controlled trial, /dk/atira/pure/subjectarea/asjc/2700/2736, name=Pharmacology (medical), /dk/atira/pure/subjectarea/asjc/2700/2745, name=Rheumatology |
| الوصف: | 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.govTest, NCT03708718. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://discovery.dundee.ac.uk/en/publications/9fe0d8d7-6494-4774-8dc1-9c77b548bc73Test |
| DOI: | 10.1093/rheumatology/kead012 |
| الإتاحة: | https://doi.org/10.1093/rheumatology/kead012Test https://discovery.dundee.ac.uk/en/publications/9fe0d8d7-6494-4774-8dc1-9c77b548bc73Test https://discovery.dundee.ac.uk/ws/files/95502939/kead012.pdfTest http://www.scopus.com/inward/record.url?scp=85169503434&partnerID=8YFLogxKTest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.C0735B6A |
| قاعدة البيانات: | BASE |
| DOI: | 10.1093/rheumatology/kead012 |
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