Pulse methylprednisolone did not improve survival in acute IPF exacerbation

Design

Randomised, open-label, multicentre superiority trial

Population

100 adults with acute exacerbation of IPF, 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%

SAFER, an open-label randomised trial at eight South Korean university hospitals, enrolled 100 adults with acute exacerbation of idiopathic pulmonary fibrosis (IPF). Patients received pulse intravenous methylprednisolone (10 mg/kg for three days) or a non-pulse regimen (1 mg/kg for seven days), both followed by a protocolised taper and low-dose maintenance prednisolone. Published in the American Journal of Respiratory and Critical Care Medicine on 30 September 2026.

Twenty-eight-day mortality was 10.0% with pulse dosing and 14.6% with non-pulse dosing (risk difference -4.6 points, 95% CI -18.8 to 9.1). At 90 days it was 24.5% versus 29.8%. ICU admission, ventilation, ECMO and adverse events did not differ.

Pulse methylprednisolone is widely used for acute IPF exacerbation despite little evidence, and guidelines recommend steroids only weakly without specifying a dose. This trial finds no clear advantage for the higher dose.

With 100 patients, the confidence intervals are wide and a modest benefit or harm cannot be ruled out. Guidelines have not changed. But in the absence of a demonstrated benefit, the lower dose is a defensible choice, especially in patients at risk from steroid side effects.

• Consider 1 mg/kg methylprednisolone rather than pulse doses for acute IPF exacerbation
• Weigh steroid harms such as hyperglycaemia, infection and delirium when choosing the dose
• Exclude infection, heart failure and pulmonary embolism before labelling an exacerbation
• Discuss goals of care early; 90-day mortality was about a quarter in both groups
• Continue antifibrotic therapy where already established

Why it matters

It brings randomised evidence on dose to a setting where pulse steroids are given largely by habit.

Don't overread it

With 100 patients, the trial cannot exclude a modest difference in either direction.

The statistics, in plain English

The 28-day mortality difference has a confidence interval from about 19 points better to 9 points worse with pulse dosing, which is too wide to declare the doses equivalent. It does show there is no large, obvious benefit to pulse therapy.

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