Background: Several sarcoidosis patients require treatment with corticosteroids to prevent organ damage and provide symptom control. However, corticosteroids are associated with numerous side effects and can be detrimental to patients if used long-term. Roflumilast is approved for the treatment of COPD and has been studied with positive results in patients with fibrosing sarcoidosis. Due to its mode of action, it might target proinflammatory and profibrotic pathways in sarcoidosis and could be a suitable medication in sarcoidosis in general.

Methods: We retrospectively analyzed a cohort of 51 sarcoidosis patients treated with Roflumilast off-lable between 2010 and 2020 at the Clinic of Pneumology, University Hospital Freiburg. Medical records, lung function and laboratory results were reviewed.

Results: From the 51 patients, 33 patients received Roflumilast for at least 6 months, whereas 18 ceased treatment, mostly because of side effects. Patients on Roflumilast were less likely to have a decrease in FEV1 of more than 10% of their mean FEV1 compared to patients without Roflumilast (OR=0.2; 95% CI 0.08-0.5). Therapy escalation (steroid pulse therapies, increase of prednisone dose, additional 2nd/3rd line treatment) was documented in 49/97 (51%) vs 100/144 (69%) of ambulatory visits (OR=0.45; 95% CI 0.26-0.76). The most common side effects reported were gastrointestinal disorders. No severe side effects were seen.  

Conclusion: Sarcoidosis patients receiving Roflumilast have less lung function loss and are less likely to require therapy escalation. Roflumilast could be a therapeutic option in sarcoidosis.