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Clinical Investigations: SARCOID |

Etanercept for the Treatment of Stage II and III Progressive Pulmonary Sarcoidosis*

James P. Utz; Andrew H. Limper; Sanjay Kalra; Ulrich Specks; John P. Scott; Zvezdana Vuk-Pavlovic; Darrell R. Schroeder
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*From the Divisions of Pulmonary and Critical Care Medicine (Drs. Utz, Limper, Kalra, Specks, Scott, and Vuk-Pavlovic) and Biostatistics (Mr. Schroeder), Mayo Clinic and Mayo Foundation, Rochester, MN.

Correspondence to: James P. Utz, MD, FCCP, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN 55905



Chest. 2003;124(1):177-185. doi:10.1378/chest.124.1.177
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Background: Tumor necrosis factor (TNF)-α is produced by macrophages and other cells, and is believed to participate in granulomatous inflammation. Targeted antagonism of TNF-α has been proposed as a novel treatment strategy for sarcoidosis. Etanercept is a dimeric fusion protein that binds specifically to TNF-α, rendering it biologically inactive.

Objective: To assess whether etanercept has potential efficacy in the treatment of progressive pulmonary sarcoidosis.

Design: Prospective, open-label, phase-2 treatment trial.

Setting: Mayo Clinic, Rochester, MN.

Patients: Stage II or III progressive pulmonary sarcoidosis.

Intervention: Etanercept, 25 mg subcutaneously twice weekly.

Measurements: Pulmonary function, chest radiographs, dyspnea, and TNF-α levels in serum and BAL fluid.

Results: The study was terminated after the enrollment of 17 patients due to an early-stop clause of the pretrial study design related to excessive treatment failures. Neither absolute levels of TNF-α nor TNF-α activity in the serum, BAL fluid, or alveolar macrophages were able to predict which patients would respond to etanercept.

Conclusions: In patients with progressive stage II or III pulmonary sarcoidosis, etanercept was frequently associated with early or late treatment failure. These data would not support the design of a large multicenter randomized trial comparing etanercept with conventional corticosteroid therapy.

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