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Blood, 15 October 2008, Vol. 112, No. 8, pp. 3073-3081.
Prepublished online as a Blood First Edition Paper on July 29, 2008; DOI 10.1182/blood-2008-03-143412.
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CLINICAL TRIALS AND OBSERVATIONS
The impact of soluble tumor necrosis factor receptor etanercept on the treatment of idiopathic pneumonia syndrome after allogeneic hematopoietic stem cell transplantation
Gregory A. Yanik1,2,
Vincent T. Ho3,
John E. Levine1,2,
Eric S. White4,
Thomas Braun5,
Joseph H. Antin3,
Joel Whitfield1,2,
Joseph Custer6,
Dawn Jones1,2,
James L. M. Ferrara1,2, and
Kenneth R. Cooke1
Departments of1 Pediatrics and
2 Internal Medicine, Blood and Marrow Transplantation Program, University of Michigan, Ann Arbor;
3 Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA; and
4 Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, and
Departments of5 Biostatistics and
6 Pediatrics, Critical Care Medicine, University of Michigan, Ann Arbor
Idiopathic pneumonia syndrome (IPS) refers to a diffuse, noninfectious, acute lung injury after hematopoietic stem cell transplantation. Historically, IPS is associated with respiratory failure and mortality rates exceeding 50%. Preclinical studies have implicated tumor necrosis factor- as an important effector molecule in the development of disease. We studied the tumor necrosis factor- inhibitor, etanercept, combined with corticosteroids in treating 15 patients (median age, 18 years; range, 1-60 years) with IPS. Eight of 15 patients required mechanical ventilation at therapy onset. Etanercept was administered subcutaneously at a dose of 0.4 mg/kg (maximum 25 mg) twice weekly, for a maximum of 8 doses. Therapy was well tolerated with no infectious pulmonary complications noted. Ten of 15 patients had a complete response, defined as the ability to discontinue supplemental oxygen support during study therapy. The median time to complete response was 7 days (range, 3-18 days), with a day 28 survival of 73%. IPS onset was associated with elevations of several inflammatory proteins in the bronchoalveolar lavage fluid and plasma, and response to therapy correlated with reductions in pulmonary and systemic inflammation. The combination of etanercept and corticosteroids is safe and is associated with high response rates and improved survival in patients with IPS.
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