A Phase II randomized controlled trial of oral prednisolone in early diffuse cutaneous systemic sclerosis (PRedSS).
Author
Griffiths-Jones DJGarcia YS
Ryder WD
Pauling JD
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 JC
Denton CP
Herrick AL
Affiliation
The University of Manchester; Royal United Hospitals Bath NHS Trust; Cambridge University Hospitals NHS Foundation Trust; The Dudley Group NHS Foundation Trust et alPublication date
01/09/2023Subject
Rheumatology
Metadata
Show full item recordAbstract
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. 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. 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. The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.Citation
Griffiths-Jones DJ, Garcia YS, Ryder WD, Pauling JD, 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 JC, Denton CP, Herrick AL. A Phase II randomized controlled trial of oral prednisolone in early diffuse cutaneous systemic sclerosis (PRedSS). Rheumatology (Oxford). 2023 Sep 1;62(9):3133-3138. doi: 10.1093/rheumatology/kead012. PMID: 36637209; PMCID: PMC10473191Type
ArticlePMID
36637209Journal
RheumatologyPublisher
Oxford University Pressae974a485f413a2113503eed53cd6c53
10.1093/rheumatology/kead012