The PREDMETH trial: Effectiveness of methotrexate versus prednisone as first-line therapy for pulmonary sarcoidosis – A randomized controlled trial

Project summary

Sarcoidosis is a multisystem, granulomatous disorder, most commonly affecting the lungs. Symptom burden is high, and quality of life (QoL) and social participation are negatively affected. Prednisone is currently the first-choice therapy in pulmonary sarcoidosis and leads to short-term improvement of lung function. Unfortunately, prednisone has major side-effects and is associated with impaired QoL. Methotrexate is presently the second-line therapy, and it appears to have fewer side-effects.
Wijsenbeek and colleagues hypothesize that first-line treatment with methotrexate is as effective as prednisone, with fewer side-effects and better QoL. In a prospective, randomized, non-blinded, multi-center, non-inferiority trial they will investigate effectiveness and tolerability of methotrexate versus prednisone as first-line therapy in pulmonary sarcoidosis and aim to obtain novel insights in course of disease and treatment response by studying known biomarkers as well as new, potentially valuable markers.

If the study confirms the hypothesis that methotrexate is as effective as prednisone as first line treatment for sarcoidosis, this will initiate a change in practice and international guidelines, and improvement of QoL.