Mallinckrodt plc announced new treatment guidelines for sarcoidosis from the European Respiratory Society, which include use of Acthar® Gel (repository corticotropin injection) therapy in the clinical management of certain patients with pulmonary sarcoidosis, published in European Respiratory Journal. The treatment guidelines are the first ERS-issued evidence-based clinical practice recommendations, aimed at providing guidance to physicians treating sarcoidosis patients, to include Acthar Gel. In addition, the guidelines support existing consensus recommendations on the use of Acthar Gel in the management of patients with pulmonary sarcoidosis based on a recent U.S. Sarcoidosis Expert Panel Consensus Statement, previously published in European Respiratory Review. Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of symptomatic sarcoidosis and is only commercially available in the U.S.3 Please see Important Safety Information for Acthar Gel below. The guidelines developed by a ERS Task Force committee composed of clinicians, methodologists and patient advocates with experience in sarcoidosis list Acthar Gel among the various anti-inflammatory treatments for pulmonary sarcoidosis and note it can be used on a case-by-case basis when other therapies are ineffective or not tolerated. Additionally, the guidelines state that recent studies have suggested the effectiveness of Acthar Gel as a steroid-sparing agent in advanced sarcoidosis. The guidelines acknowledge that the potential mechanisms of action of Acthar Gel have not been fully elucidated and that its understanding has continued to evolve with further research. Mallinckrodt continues to invest in studies to advance the characterization of the proposed mechanisms of action and to better understand the efficacy and safety profiles of Acthar Gel. The U.S. Sarcoidosis Expert Panel Consensus Statement published in European Respiratory Review includes guidance on dosage, concomitant medications and adverse event (AE) management of advanced sarcoidosis with Acthar Gel. The panel, comprised of 12 independent physicians with expertise in treating patients with sarcoidosis, recommended a starting dose of Acthar Gel 40 units twice a week for most patients with less severe disease, but did not achieve consensus on whether a higher initial dose was indicated for patients with a more severe condition. In addition, Acthar Gel should be continued at a maintenance dose for most patients who respond to therapy, particularly those with chronic refractory/advanced sarcoidosis, and the maintenance dose should be individualized for each patient. If patients develop major adverse events, the recommendations suggested considering reducing or discontinuing Acthar Gel. The panel also made recommendations related to discontinuation of therapy, including weaning to the lowest efficacious dose if the patient has stable, well-controlled disease after six to 12 months of therapy. Study limitations include the following: There are no generally accepted criteria for consensus. The study is based on a degree of consensus, which may be refuted by future rigorous studies. Panelists were not accountable for their responses, and opinions may be based on insufficient/minimal consideration. Panel selection and questionnaire development may introduce bias, and perspectives from stakeholders other than U.S.-based physicians may have been missed. Regarding the use of concomitant medications, the panel recommended that concomitant steroids be tapered and potentially discontinued as quickly as possible in patients receiving Acthar Gel, but concomitant use of immunosuppressive medications should be continued. Consensus recommendations were also reached for AE management, including that Acthar Gel be titrated down or discontinued if other interventions fail or if AEs are severe and significant.