title: 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.
  
  
  CONCLUSIONS
  Our results suggest that infliximab adds minimal potential benefit to corticosteroids for pulmonary sarcoidosis at doses above 15-20 mg/day of prednisone.
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Albany Medical College, Albany, NY, USA. Electronic address: judsonm@mail.amc.edu.
authors.forename: Marc A
authors.initials: MA
authors.lastname: Judson
authors.affiliation: University of Cincinnati Medical Center, Cincinnati, OH, USA.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Baughman
authors.affiliation: Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Costabel
authors.affiliation: Janssen Research & Development, LLC, Spring House, PA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: Janssen Research & Development, LLC, Spring House, PA, USA.
authors.forename: Elliot S
authors.initials: ES
authors.lastname: Barnathan
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D002908:Chronic Disease; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012189:Retrospective Studies; D017565:Sarcoidosis, Pulmonary / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D005938:Glucocorticoids; D000069285:Infliximab; D011241:Prednisone
keywords: Corticosteroids; Infliximab; Pulmonary; Sarcoidosis; Treatment