A radiographic scoring method (Muers et al Sarcoidosis Vasc Diffuse Lung Dis 1997;14:46) was devised to enable rigorous evaluation of chest radiographs (CXR) in subjects with pulmonary sarcoidosis. The purpose of this study was to evaluate the effect of infliximab on the radiographic appearance of pulmonary sarcoidosis using this scoring system.
One hundred thirty-eight subjects were randomized to placebo, 3 or 5mg/kg infliximab at 34 centers. Subjects were infused at week 0, 2, 6, 12, 18, 24 and followed through week 52. Inclusion criteria included a diagnosis of sarcoidosis for ≥1 year; a forced vital capacity (FVC) of ≥50-≤85% predicted and stage II or III on CXR. Two experienced radiologists, blinded to treatment and time of exam, scored the baseline, 6 and 24 week CXR for extent (0-4) and profusion (0-4) for each of four types of shadows: reticulonodular (R), mass (M), confluent (C), and fibrosis (F). Over 90% of CXR at each time point were available for review.
Scores in each domain were reasonably balanced at baseline. There were no significant differences in the M, C or F scores over time in any group. However, there were significant reductions in the R score at both time points in both treatment groups compared to baseline, with no change in the placebo group. Subgroup analyses showed that improvement in the primary endpoint (change in % predicted FVC at week 24) appeared to be restricted to subjects (n=78) with an R score >0 at baseline (5.2% improvement, p<0.001).
Infliximab appears to be effective in improving reticulonodular infiltrates on CXR without affecting the other type of shadows in subjects with chronic pulmonary sarcoidosis.
The treatment effect of infliximab in improving FVC appears restricted to patients with baseline CXR evidence of reticulonodular infiltrates.
M Kavuru, Grant monies (from industry related sources) Research grants; Employee; Consultant fee, speaker bureau, advisory committee, etc.