Pulse Corticosteroids Show No Survival Advantage in Acute IPF Exacerbations

Pulse-dose corticosteroids are widely used for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF), despite limited evidence and guidelines that do not define dose or duration. The open-label SAFER trial randomized 100 adults at eight South Korean university hospitals to intravenous methylprednisolone at 10 mg/kg for 3 days (n = 51) or a nonpulse regimen of 1 mg/kg for 7 days (n = 49). Both groups subsequently received protocolized tapering and maintenance low-dose prednisolone. Primary outcomes were all-cause mortality at 28 and 90 days.

Mortality at 28 days was 10.0% with pulse therapy versus 14.6% with nonpulse therapy: a risk difference of −4.6 percentage points (95% CI, −18.8 to 9.1; P = 0.549). At 90 days, mortality was 24.5% versus 29.8%, respectively, a difference of −5.3 percentage points (95% CI, −23.1 to 12.6; P = 0.648). An analysis treating transplantation as a competing event also found no demonstrable difference in 90-day mortality. Secondary outcomes were not demonstrably different between groups.

These findings do not establish a survival advantage for pulse dosing. However, the small sample, open-label design, and wide confidence intervals limit interpretation; absence of demonstrated superiority does not establish equivalence. Because both groups received corticosteroids, the trial does not determine their benefit versus no corticosteroid treatment. This report is based on the abstract; full text was unavailable.