N Engl J Med

ATS 2025: Methotrexate on par with prednisone in the treatment of pulmonary sarcoidosis

May 22, 2025

Methotrexate appears to be a viable first-line alternative to prednisone for pulmonary sarcoidosis, according to findings shared at the American Thoracic Society annual meeting. Given its comparable efficacy and potentially more tolerable side effect profile, methotrexate may offer a steroid-sparing option for patients, particularly those at risk for corticosteroid-related complications.

Study details: The multicenter, open-label, noninferiority PREDMETH trial (NCT04314193) randomized 138 treatment-naïve patients with pulmonary sarcoidosis to receive either prednisone or methotrexate for 24 weeks. The primary endpoint was the mean change in percent predicted forced vital capacity (FVC) from baseline to week 24, with a noninferiority margin of 5 percentage points.

Results: Methotrexate (6.11 percentage points) was noninferior to prednisone (6.75 percentage points) for improvement in FVC at 24 weeks (difference –1.17 percentage points; 95% confidence interval [CI] –4.27 to 1.93). The frequency of adverse events was similar between groups. Prednisone was associated with weight gain, insomnia, and increased appetite, while methotrexate was more often associated with nausea, fatigue, and abnormal liver function tests.

Source:

Kahlmann V, et al. (2025, May 18). N Engl J Med. First-Line Treatment of Pulmonary Sarcoidosis with Prednisone or Methotrexate. https://pubmed.ncbi.nlm.nih.gov/40387020/