High-dose (40 mg) versuslow-dose (20 mg) prednisolone for treating sarcoidosis: a randomised trial (SARCORT trial)

Abstract

Background

Current guidelines recommend 20–40 mg·day ⁻¹of oral prednisolone for treating pulmonary sarcoidosis. Whether the higher dose (40 mg·day ⁻¹) can improve outcomes remains unknown.

Methods

We conducted an investigator-initiated, single-centre, open-label, parallel-group, randomised controlled trial ( ClinicalTrials.govidentifierNCT03265405). Consecutive subjects with pulmonary sarcoidosis were randomised (1:1) to receive either high-dose (40 mg·day ⁻¹initial dose) or low-dose (20 mg·day ⁻¹initial dose) oral prednisolone, tapered over 6 months. The primary outcome was the frequency of relapse or treatment failure at 18 months from randomisation. Key secondary outcomes included the time to relapse or treatment failure, overall response, change in forced vital capacity (FVC, in litres) at 6 and 18 months, treatment-related adverse effects and health-related quality of life (HRQoL) scores using the Sarcoidosis Health Questionnaire and Fatigue Assessment Scale.

Findings

We included 86 subjects (43 in each group). 42 and 43 subjects completed treatment in the high-dose and low-dose groups, respectively, while 37 (86.0%) and 41 (95.3%), respectively, completed the 18-month follow-up. 20 (46.5%) subjects had relapse or treatment failure in the high-dose group and 19 (44.2%) in the low-dose group (p=0.75). The mean time to relapse/treatment failure was similar between the groups (high-dose 307 days versuslow-dose 269 days, p=0.27). The overall response, the changes in FVC at 6 and 18 months and the incidence of adverse effects were also similar. Changes in HRQoL scores did not differ between the study groups.

Interpretation

High-dose prednisolone was not superior to a lower dose in improving outcomes or the HRQoL in sarcoidosis and was associated with similar adverse effects.