Are patients with pulmonary sarcoidosis overtreated with corticosteroids?

Efzofitimod did not lead to a significant improvement in background corticosteroid use compared with placebo in patients with pulmonary sarcoidosis; however, it raised the possibility that many patients may be overtreated with corticosteroids, according to results from the largest trial in sarcoidosis ever reported.

Dr Daniel Culver (Cleveland Clinic, OH, USA) presented the results from the EFZO-FIT (NCT05415137), a randomised, double-blind, placebo-controlled trial. Participants were included if they had a diagnosis of pulmonary sarcoidosis for >6 months and were on a stable dose of oral corticosteroids (7.5-25 mg/day). Randomisation (1:1:1) assigned participants to efzofitimod 5mg/kg, 3mg/kg, or placebo administered intravenously every 4 weeks for 48 weeks. Tapering of corticosteroids began at randomisation and continued until Week 12, but reintroducing steroid treatment was allowed. The primary endpoint was the change in mean daily dose of corticosteroids, and 268 patients were randomised.

The trial did not meet its primary endpoint. All three groups reduced their background oral corticosteroid dose by Week 48, corresponding to a least-squares mean reduction of 7.1 mg with placebo, 7.1 mg with efzofitimod 3 mg/kg and -7.9 mg with efzofitimod 5 mg/kg (P=not significant for both comparisons with placebo). However, the trial showed that patients were on very high baseline doses of corticosteroids, as the reduction in dose also occurred in the placebo group. In terms of safety, efzofitimod was well-tolerated and serious adverse events were rare.

“This is the largest trial to date in sarcoidosis investigating a safe and well-tolerated drug”, concluded Dr Culver. “This provides a path forward, and additional analyses are underway.”

1. Hsieh CA, et al. EFZO-FIT, the largest ever interventional trial in pulmonary sarcoidosis. ERS Congress, 27 September–1 October 2025, Amsterdam, the Netherlands.

Medical writing support was provided by Mihai Surducan, PhD.

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Posted on 3 October 20253 November 2025