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Efficacy of infliximab in extrapulmonary sarcoidosis: results from a randomised trial

¹ Division of Pulmonary and Critical Medicine, Medical University of South Carolina, Charleston, SC, ² University of Cincinnati Medical Center, Cincinnati, ⁵ Dept of Pulmonary and Critical Care Medicine, Cleveland Clinic Foundation, Cleveland, OH, ⁴ Centocor, Inc., Malvern, PA, USA, ³ Dept of Pneumology and Allergology, Ruhrlandklinik, Medical Faculty, University of Duisburg-Essen, Essen, Germany. ⁶ Dept of Respiratory Medicine, Sarcoidosis Management Team, University Hospital Maastricht, Maastricht, The Netherlands. ⁷ For full details of the Centocor T48 Sarcoidosis investigators, please see the Acknowledgements section.

CORRESPONDENCE: M. A. Judson, Division of Pulmonary and Critical Care Medicine, 96 Jonathan Lucas Street, Charleston, SC 29425, USA. Fax: 1 8437920732. E-mail: judsonma{at}musc.edu

Keywords: Extrathoracic, infliximab, sarcoidosis, severity, therapy

Received: April 30, 2007
Accepted January 25, 2008

The aim of the present study was to investigate the efficacy of infliximab for the treatment of extrapulmonary sarcoidosis.

A prospective, randomised, double-blind, placebo-controlled trial was conducted, with infliximab at 3 and 5 mg·kg^–1 body weight administered over 24 weeks. Extrapulmonary organ severity was determined by a novel severity tool (extrapulmonary physician organ severity tool; ePOST) with an adjustment for the number of organs involved (ePOSTadj). In total, 138 patients enrolled in the trial of infliximab versus placebo for the treatment of chronic corticosteroid-dependent pulmonary sarcoidosis.

The baseline severity of extrapulmonary organ involvement, as measured by ePOST, was similar across treatment groups. After 24 weeks of drug-therapy study, the change from baseline to week 24 in ePOST was greater for the combined infliximab group compared with the placebo group. After adjustment for the number of extrapulmonary organs involved, the improvement in ePOSTadj observed in the combined infliximab group was also greater than that observed in placebo-treated patients, after 24 weeks of therapy. 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 the severity tool described in the present study.

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