Changes in chest roentgenogram of sarcoidosis patients during a clinical trial of infliximab therapy: comparison of different methods of evaluation.
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 kappa = 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 kappa = 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).


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov Identifier: NCT00073437.
Baughman
Robert P
RP
University of Cincinnati Medical Center, Cincinnati, OH. Electronic address: bob.baughman@uc.edu.
Shipley
Ralph
R
University of Cincinnati Medical Center, Cincinnati, OH.
Desai
Sujal
S
Imperial College of Science, Technology, and Medicine, London, UK.
Drent
Marjolein
M
Maastricht University Medical Centre, Maastricht, the Netherlands.
Judson
Marc A
MA
Medical University of South Carolina, Charleston, SC.
Costabel
Ulrich
U
Ruhrlandklinik and Medical Faculty, University of Duisburg-Essen, Essen, Germany.
du Bois
Roland M
RM
Imperial College of Science, Technology, and Medicine, London, UK.
Kavuru
Mani
M
East Carolina University, Greenville, NC.
Schlenker-Herceg
Rozsa
R
Centocor, Inc, Malvern, PA.
Flavin
Susan
S
Centocor, Inc, Malvern, PA.
Lo
Kim Hung
KH
Centocor, Inc, Malvern, PA.
Barnathan
Elliot S
ES
Centocor, Inc, Malvern, PA.
D000328:Adult; D000367:Age Factors; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000069285:Infliximab; D008875:Middle Aged; D011336:Probability; D013902:Radiography, Thoracic / Q000379:methods*; D012016:Reference Values; D015203:Reproducibility of Results; D012129:Respiratory Function Tests; D018570:Risk Assessment; D017565:Sarcoidosis, Pulmonary / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D012737:Sex Factors; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab