- Design
- Randomised, open-label, multicentre superiority trial
- Population
- 100 adults with acute exacerbation of IPF in 8 Korean hospitals
- Primary outcome
- All-cause mortality at 28 and 90 days
- Effect
- 28-day 10.0% vs 14.6% (RD −4.6, 95% CI −18.8 to 9.1); 90-day 24.5% vs 29.8%
The SAFER trial, in the American Journal of Respiratory and Critical Care Medicine (30 September), randomised 100 adults with acute exacerbation of idiopathic pulmonary fibrosis at eight Korean university hospitals. Half received pulse methylprednisolone 10 mg/kg for three days; half received 1 mg/kg for seven days; both then tapered to low-dose prednisolone.
Mortality was 10.0% with pulse against 14.6% with standard dose at 28 days, and 24.5% against 29.8% at 90 days; neither difference was significant. ICU admission, ventilation, ECMO and transplant outcomes did not differ.
Pulse dosing is widely used on little evidence. This trial did not show it helps, though with 100 patients it cannot exclude a modest effect either way. Guidelines continue to recommend steroids only weakly, and the trial supports using a standard dose rather than escalating to pulse therapy by default.
- Pulse methylprednisolone did not improve 28- or 90-day survival over 1 mg/kg
- Consider a standard-dose regimen rather than defaulting to pulse therapy
- Look for and treat triggers: infection, heart failure, pulmonary embolism
- Discuss goals of care early; 90-day mortality was about one in four
- Guidelines still recommend steroids only weakly in this setting
Why it matters
It challenges the reflex escalation to pulse methylprednisolone in a setting with high mortality and limited evidence.
Don't overread it
Small, open-label trial — the wide confidence intervals cannot rule out a modest benefit or harm.
The statistics, in plain English
The 28-day risk difference of −4.6 points has a 95% CI from −18.8 to +9.1, so the true effect could range from a substantial benefit to a modest harm. 'No significant difference' here means 'not shown', not 'shown to be equal'.
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