Systemic sclerosis & Raynaud's
A Phase II randomized controlled trial of oral prednisolone in early diffuse cutaneous systemic sclerosis (PRedSS)
Primary result · HAQ-DI score, adjusted mean differenceResult — go to the resultAdjusted mean difference −0.10 97.5% CI −0.29 to 0.10- terminated early
- Terminated early primarily due to the Covid-19 pandemic; underpowered
Authors' 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
Study context
- Population
- Patients with early diffuse cutaneous SSc (dcSSc)target 72
- Participants
- 35 patients
- Comparison
- Prednisolone vs matching placebo for 6 months
- Prednisolonen = 17
- Placebo/controln = 18reference
- Primary endpoint
- Co-primary: HAQ Disability Index (HAQ-DI) and modified Rodnan skin score (mRSS)
- Follow-up
- 3 months
Methodological detailsPhase II, multicentre, double-blind, converted to open-label during the Covid-19 pandemic
- Phase II
- Multicentre
- Double-blind
- Converted to open-label during the Covid-19 pandemic
Primary result
HAQ-DI score, adjusted mean difference
Adjusted mean difference
−0.10
97.5% CI −0.29 to 0.10
P = 0.254
Prednisolonevs Placebo/control
adjusted mean difference −0.10 (97.5% CI −0.29 to 0.10); P = 0.254
As reported in the abstract
Secondary outcomes
| Outcome | Adjusted mean difference (97.5% CI) | P value | |
|---|---|---|---|
| Co-primary: mRSS, adjusted mean difference · 3 monthsFavouring prednisolone but not significantly | −3.90 (−8.83 to 1.03) | P = 0.070 | |
| −10−505Difference (linear scale) |
| Outcome | P value |
|---|---|
| Pain · 3 monthsSignificantly less pain with prednisolone | P = 0.027 |
| Anxiety · 3 monthsSignificantly less anxiety with prednisolone | P = 0.018 |
| Helplessness · 3 monthsSignificantly less helplessness with prednisolone | P = 0.040 |
Safety
- No renal crises
- Sample size was small
Original publication
A Phase II randomized controlled trial of oral prednisolone in early diffuse cutaneous systemic sclerosis (PRedSS). Rheumatology (Oxford). Published 13 January 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →