PDE-4 Inhibition in Sarcoidosis Patients: A Retrospective Single-Center Analysis of 51 Patients

Background: Several sarcoidosis patients require treatment with corticosteroids to prevent organ damage and control symptoms. 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 chronic obstructive pulmonary disease (COPD) and has been studied with positive results in patients with fibrosing sarcoidosis. Due to its mode of action, it targets proinflammatory and profibrotic pathways involved in sarcoidosis and could be a suitable medication for sarcoidosis. Methods: We retrospectively analyzed a cohort of 51 sarcoidosis patients treated with Roflumilast off-label between 2010 and 2020 at the Department of Pneumology, University Hospital Freiburg. Medical records, lung function, and laboratory results were reviewed. Results: Of the 51 patients, 33 patients received Roflumilast for at least 6 months, whereas 18 discontinued treatment, mostly due to mild to moderate gastrointestinal side effects (n = 7). No severe adverse events were observed. 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). Escalation of therapy was documented in 49/97 (51%) of ambulatory visits for patients taking Roflumilast compared to 100/144 (69%) for patients without Roflumilast (OR = 0.45; 95% CI 0.26-0.76). Conclusions: Sarcoidosis patients receiving Roflumilast had less lung function loss and were less likely to require therapy escalation. Roflumilast could be a therapeutic option in sarcoidosis.