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Published online before print February 6, 2008
Eur Respir J 2008, doi:10.1183/09031936.00051907
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ORIGINAL ARTICLE

Efficacy of Infliximab in Extrapulmonary Sarcoidosis: Results from a Randomized Trial

M.A. Judson 1*, R.P. Baughman 2, U. Costabel 3, S. Flavin 4, K.H. Lo 4, M.S. Kavuru 5, M. Drent 6, the Centocor T48 investigators 7

1 Division of Pulmonary and Critical Medicine, Medical University of South Carolina, Charleston, South Carolina, USA
2 University of Cincinnati Medical Center, Cincinnati, Ohio, USA
3 Dept of Pneumology/Allergy Ruhrlandklink Essen, Essen, Germany
4 Centocor, Inc, Malvern, PA, United States
5 Dept of Pulmonary & Critical Care Medicine, Cleveland Clinic Foundation. Cleveland, Ohio, USA
6 Dept of Respiratory Medicine, Sarcoidosis Management Team, University Hospital Maastricht, Maastricht, The Netherlands
7 See Appendix 1

* To whom correspondence should be addressed. E-mail: judsonma{at}musc.edu.


   Abstract

To investigate the efficacy of infliximab for the treatment of extrapulmonary sarcoidosis.

Prospective, randomized, double-blind, placebo-controlled trial comparing placebo with infliximab 3 mg·kg-1 and infliximab 5 mg·kg-1 given over 24 weeks. Extrapulmonary organ severity was determined by a novel severity tool (extrapulmonary Physician Organ Severity Tool, or ePOST) with an adjustment for the number of organs involved (ePOSTadj).

138 enrolled in a prospective randomized trial of infliximab versus placebo for the treatment of chronic corticosteroid-dependent pulmonary sarcoidosis.

Baseline severity of extrapulmonary organ involvement as measured by ePOST was similar across treatment groups. After 24 weeks of study drug therapy, the change from baseline to week 24 in ePOST for the combined infliximab group compared with the placebo group was greater (p<0.01). After adjustment for the number of extrapulmonary organs involved, the improvement in ePOSTadj observed in the combined infliximab group was also greater to that observed in placebo-treated patients after 24 weeks of therapy (p<0.05). The improvements in ePOST and ePOSTadj were not maintained during a subsequent 24-week washout period.

Infliximab may be beneficial compared with placebo in the treatment of extrapulmonary sarcoidosis in patients already receiving corticosteroids as assessed by this severity tool.

Keywords:  Extrathoracic, infliximab, sarcoidosis, severity, therapy




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