The potential additional benefit of infliximab in patients with chronic pulmonary sarcoidosis already receiving corticosteroids: a retrospective analysis from a randomized clinical trial.

Abstract

BACKGROUND:

Infliximab, a TNF-alpha antagonist, has shown efficacy in the treatment of sarcoidosis. Since corticosteroids inhibit TNF-alpha expression, we postulated that sarcoidosis patients receiving a sufficient corticosteroid dose may have an attenuated response to the addition of infliximab.

METHODS:

We analyzed data from a previous randomized double blind prospective trial of infliximab versus placebo for chronic pulmonary sarcoidosis. The effect of the maintenance corticosteroid dose on the change in FVC % predicted between 0 and 24 weeks (ΔFVC%pred0-24) was analyzed in two ways. First, the mean ΔFVC%pred0-24 was calculated for the placebo and infliximab groups using three different daily prednisone equivalent dose thresholds: a) <10 mg versus ≥10 mg; b) <15 mg versus ≥15 mg; c) <20 mg versus ≥20 mg. Second, in both the placebo and infliximab groups, a correlation coefficient was calculated between the maintenance corticosteroid dose and ΔFVC%pred0-24.

RESULTS:

Both the group that received infliximab and either a maintenance daily dose of <10 mg of prednisone and the group receiving ≥10 mg had a significant increase in FVC%pred0-24. However, both the groups that received infliximab and a corticosteroid dose of >15 mg of prednisone and ≥20 mg of prednisone did not demonstrate a significant ΔFVC%pred0-24. For the placebo group, there was no significant correlation between the corticosteroid dose and the ΔFVC%pred0-24. For the infliximab group, there was a significant correlation (p = 0.0097) between higher corticosteroid dose and less improvement in FVC%pred0-24.

CONCLUSION:

Our results suggest that infliximab adds minimal potential benefit to corticosteroids for pulmonary sarcoidosis at doses above 15-20 mg/day of prednisone.

• Authors: Marc A Judson, Robert P Baughman, Ulrich Costabel, Michael Mack, Elliot S Barnathan
• Journal: Respiratory medicine (Respir Med) Vol. 108 Issue 1 Pg. 189-94 (Jan 2014) ISSN: 1532-3064 [Electronic] England
• PMID: 24361164 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 Elsevier Ltd. All rights reserved.

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Antibodies, Monoclonal
• Glucocorticoids
• Infliximab
• Prednisone

Topics

• Adult
• Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)
• Antibodies, Monoclonal (therapeutic use)
• Chronic Disease
• Drug Therapy, Combination
• Female
• Glucocorticoids (therapeutic use)
• Humans
• Infliximab
• Male
• Middle Aged
• Prednisone (therapeutic use)
• Randomized Controlled Trials as Topic
• Research Design
• Retrospective Studies
• Sarcoidosis, Pulmonary (drug therapy)
• Treatment Outcome