Systemic sclerosis & Raynaud's
Efficacy of methylprednisolone in very early systemic sclerosis: results of the ‘Hit Hard and Early’ randomized controlled trial
Authors' conclusion
No clinically relevant effect of short-term methylprednisolone in patients with very early SSc was observed. A substantial proportion of patients showed disease progression.
Study context
- Population
- Adults with puffy fingers for <3 years, specific auto-antibodies and meeting the Very Early Diagnosis of systemic sclerosis (SSc) criteria (70% female; median age 52.9 years)87 screened
- Participants
- 30 adults
- Comparison
- Methylprednisolone 1000 mg i.v. for three consecutive days three times at monthly intervals vs placebo
- Methylprednisolonen = 21
- Placebon = 9reference
- Primary endpoint
- Nailfold capillary density
- Follow-up
- Week 12
Methodological detailsplacebo-controlled, 2:1 randomisation, linear regression adjusted for baseline values and stratification variables
- Placebo-controlled
- 2:1 randomisation
- Linear regression adjusted for baseline values and stratification variables
Primary result
As reported in the abstract
Nailfold capillary density, difference between groups
- No difference in nailfold capillary density at 12 weeks
Secondary outcomes
Secondary outcomes (capillary density at 52 weeks, number of megacapillaries, patient-reported outcomes)
- No difference in any of the secondary outcomes
Disease progression (all patients) · 1 year
- Patients with disease progression
- 11 (37%)
Relevant pulmonary function decline (all patients) · 52 weeks
- Patients with relevant pulmonary function decline
- 7 (23%)
Safety
- No serious adverse events reported
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Efficacy of methylprednisolone in very early systemic sclerosis: results of the ‘Hit Hard and Early’ randomized controlled trial. Rheumatology (Oxford). Published 29 March 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →