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Original Research: SARCOIDOSIS |

Changes in Chest Roentgenogram of Sarcoidosis Patients During a Clinical Trial of Infliximab Therapy: Comparison of Different Methods of Evaluation

Robert P. Baughman, MD, FCCP; Ralph Shipley, MD, FCCP; Sujal Desai, MD; Marjolein Drent, MD; Marc A. Judson, MD, FCCP; Ulrich Costabel, MD; Roland M. du Bois, MD; Mani Kavuru, MD; Rozsa Schlenker-Herceg, MD; Susan Flavin, MSN; Kim Hung Lo, PhD; Elliot S. Barnathan, MD; on behalf of the Sarcoidosis Investigators
Author and Funding Information

From the University of Cincinnati Medical Center (Drs. Baughman and Shipley), Cincinnati, OH; Imperial College of Science, Technology, and Medicine (Drs. Desai and du Bois), London, UK; Maastricht University Medical Centre (Dr. Drent), Maastricht, the Netherlands; Medical University of South Carolina (Dr. Judson), Charleston, SC; Ruhrlandklinik and Medical Faculty (Dr. Costabel), University of Duisburg-Essen, Essen, Germany; East Carolina University (Dr. Kavuru), Greenville, NC; and Centocor, Inc (Drs. Schlenker-Herceg, Lo, and Barnathan, and Ms. Flavin), Malvern, PA.

Robert P. Baughman, MD, FCCP, University of Cincinnati, Internal Medicine, University of Cincinnati Medical Center, 1001 Holmes, Eden Ave and Albert Sabin Way, Cincinnati, OH 45267-0565; e-mail: bob.baughman@uc.edu


Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/site/misc/reprints.xhtml).


© 2009 American College of Chest Physicians


Chest. 2009;136(2):526-535. doi:10.1378/chest.08-1876
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Background:  The best method to interpret the chest roentgenogram and its sensitivity to detect effect of treatment for sarcoidosis remains unclear. In a double-blind, randomized trial of infliximab for chronic pulmonary sarcoidosis, changes in serial chest roentgenograms were examined by radiologists, blinded to order or treatment.

Methods:  Chest roentgenograms were obtained at 0, 6, and 24 weeks of therapy with either placebo, 3 mg/kg infliximab, or 5 mg/kg infliximab. Films were reviewed in random order by two independent radiologists, unaware of treatment. The films were compared using two methods: the prespecified objective assessment, a scoring system previously proposed by Muers; and the post hoc assessment, a 5-point Likert scale global assessment between two films.

Results:  Of 138 patients enrolled in the study, chest roentgenograms for all studies were available on 130 patients. There was only fair agreement between the two radiologists in the original stage of the chest roentgenogram (weighted κ = 0.43; 95% confidence interval [CI], 0.32 to 0.54). For the Likert scale of global assessment of change, there was good agreement between the two readers (weighted κ = 0.61; 95% CI, 0.51 to 0.71). There was good correlation between the two readers for the various components of the Muers score, especially the reticulonodular (R) score (R = 0.578; p < 0.05). The initial R score was positively correlated with improvement in FVC with infliximab therapy (R = 0.239; p < 0.05).

Conclusion:  Global assessment and the Muers scoring system were associated with good agreement between two expert readers. Improvement in both scores correlated with improvement in FVC.

Trial registration:  ClinicalTrials.gov Identifier: NCT00073437

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