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Respir Med. 2014 Jan;108(1):189-94. doi: 10.1016/j.rmed.2013.11.019. Epub 2013 Dec 10.

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

Author information

1
Division of Pulmonary and Critical Care Medicine, Albany Medical College, Albany, NY, USA. Electronic address: judsonm@mail.amc.edu.
2
University of Cincinnati Medical Center, Cincinnati, OH, USA.
3
Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany.
4
Janssen Research & Development, LLC, Spring House, PA, USA.

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.

KEYWORDS:

Corticosteroids; Infliximab; Pulmonary; Sarcoidosis; Treatment

PMID:
24361164
DOI:
10.1016/j.rmed.2013.11.019
[Indexed for MEDLINE]
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