Chest
Volume 136, Issue 2, August 2009, Pages 526-535
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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

https://doi.org/10.1378/chest.08-1876Get rights and content

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

Section snippets

Materials and Methods

This was a multicenter trial comprised of 34 sites from 15 countries in North America and Europe. A detailed description of the study design and main clinical outcome has been published previously.10 Sarcoidosis was diagnosed based on standard criteria.11 All patients underwent a biopsy of at least one site demonstrating noncaseating granulomas, a clinical presentation consistent with sarcoidosis, and no alternative cause for granulomatous disease identified. In addition, all patients had to be

Results

A total of 138 patients were enrolled in the study. The characteristics of the patients have been reported elsewhere.10 Of the 138 patients, not all patients had their chest roentgenograms reviewed at all times because of randomization but not treated (3 patients) and discontinuation from the study prior to week 24 (2 patients). Missing or inadequate chest roentgenograms were discovered at various time points. Figure 4 summarizes the final numbers in each group.

Discussion

The current study assessed the reproducibility of chest roentgenogram interpretation in a treatment trial of pulmonary sarcoidosis. Chest roentgenogram has been recommended for initial and follow-up assessment of sarcoidosis patients.14 Improvement in the chest roentgenogram has been noted during corticosteroid therapy based on improvement in either chest radiograph stage.15, 16 Relapse after withdrawal of corticosteroids has been proceeded by chest roentgenogram changes.17 Others have used a

Acknowledgments

Author contributions: Drs. Baughman, Drent, Judson, Costabel, duBois, and Kavuru contributed to the study design as part of the steering committee, as well as the enrollment of patients into the study. Drs. Shipley and Desai are the radiologists who reviewed all the films. Drs. Barnathan, Schlenker-Herceg, and Lo, and Ms. Flavin contributed to the study design, logistics, data acquisition, and data analysis. All authors reviewed and approved the final manuscript.

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