Effectiveness of methotrexate versus prednisone as first-line treatment for pulmonary sarcoidosis

<bold>Background:</bold> The mainstay treatment for pulmonary sarcoidosis is prednisone, which often causes many side effects. There is an urgent need for better evidence-based treatments. Methotrexate appears to have fewer side effects, but has not been studied as first-line treatment. <bold>Aim:</bold> To investigate the effectiveness of methotrexate compared with prednisone as first-line treatment for pulmonary sarcoidosis. <bold>Methods:</bold> The PREDMETH study was developed by clinicians, researchers and patients. It is a randomized, multi-centre, non-inferiority trial (<ext-link>NCT04314193</ext-link>). Treatment-naïve patients with pulmonary sarcoidosis were randomly assigned to receive prednisone or methotrexate (1:1) at a predefined dosing schedule for a period of 24 weeks. The primary endpoint is change in Forced Vital Capacity (FVC) at 24 weeks (protocol: PMID 33076885). The Dutch Lung Foundation funded the study. <bold>Results:</bold> We randomized 137 patients, 74.5% male and with a mean age of 46.7 years (SD 11.87). FVC at baseline was 77.36% (SD 14.36) and diffusion capacity of the lungs for carbon monoxide was 69.78% (SD 14.87). Table 1 shows the main baseline characteristics. <bold>Discussion:</bold> The PREDMETH trial is a unique study that will provide better evidence-based treatment for pulmonary sarcoidosis. If methotrexate is as effective as prednisone with fewer side effects this will initiate a change in practice. The results of the primary endpoint are expected August 2024. <fig><object-id>erj;64/suppl_68/OA948/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>