Methotrexate Noninferior to Prednisone in Pulmonary Sarcoidosis
TUESDAY, May 20, 2025 -- For patients with pulmonary sarcoidosis, methotrexate is noninferior to prednisone with regard to the change from baseline to week 24 in the percentage of the predicted forced vital capacity (FVC), according to a study published online May 18 in the New England Journal of Medicine to coincide with the American Thoracic Society 2025 International Conference, held from May 18 to 21 in San Francisco.
Vivienne Kahlmann, M.D., from Erasmus Medical Center in Rotterdam, Netherlands, and colleagues conducted a multicenter, open-label, noninferiority trial involving patients with pulmonary sarcoidosis who had not previously received treatment. Participants were randomly assigned to receive either prednisone or methotrexate according to a prespecified treatment schedule (70 and 68 participants, respectively). The primary end point was the mean change in the percentage of the predicted FVC from baseline to week 24.
The researchers found that the unadjusted mean change in the percentage of FVC from baseline to week 24 was 6.75 and 6.11 percentage points in the prednisone and methotrexate groups, respectively. With respect to the primary end point, methotrexate was noninferior to prednisone, with an adjusted between-group difference of −1.17 percentage points (95 percent confidence interval, −4.27 to 1.93). In the two trial groups, adverse events occurred in a similar percentage of patients.
"The results of this trial show that methotrexate can be offered as an alternative for prednisone for patients with pulmonary sarcoidosis," Kahlmann said in a statement. "Some patients prioritize fast improvement of symptoms and are less afraid of side effects, while other patients may want to wait longer for treatment effects if this means they can avoid steroid toxicity."
Several authors disclosed ties to the pharmaceutical industry.
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