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Randomized, Double-Blind, Placebo-Controlled Trial of Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Idiopathic Pneumonia Syndrome after Allogeneic Stem Cell Transplantation: Blood and Marrow Transplant Clinical Trials Network Protocol
- Source :
- Biology of Blood and Marrow Transplantation. 20:858-864
- Publication Year :
- 2014
- Publisher :
- Elsevier BV, 2014.
-
Abstract
- Idiopathic pneumonia syndrome (IPS) is a diffuse, noninfectious lung injury that occurs acutely after allogeneic hematopoietic cell transplantation (HCT). IPS-related mortality has been historically high (>50%) despite treatment with systemic corticosteroids and supportive care measures. We have now examined the role of tumor necrosis factor inhibition in a randomized, double-blind, placebo-controlled trial of corticosteroids with etanercept or placebo. Thirty-four subjects (≥18 years) with IPS after HCT were randomized to receive methylprednisolone (2 mg/kg/day) plus etanercept (0.4 mg/kg twice weekly × 4 weeks; n = 16) or placebo (n = 18). No active infections and a pathogen-negative bronchoscopy were required at study entry. Response (alive, with complete discontinuation of supplemental oxygen support) and overall survival were examined. This study, originally planned to accrue 120 patients, was terminated prematurely due to slow accrual. In the limited number of patients examined, there were no differences in response rates at day 28 of study. Ten of 16 patients (62.5% [95% confidence interval {CI}, 35.4% to 84.8%]) receiving etanercept and 12 of 18 patients (66.7% [95% CI, 41.0% to 86.7%]) receiving placebo met the day 28 response definition (P = 1.00). The median survival was 170 days (95% CI, 11 to 362) with etanercept versus 64 days (95% CI, 26 to 209) with placebo (P = .51). Among responders, the median time to discontinuation of supplemental oxygen was 9 days (etanercept) versus 7 days (placebo). Therapy was well tolerated, with 1 toxicity-related death from infectious pneumonia in the placebo arm. The treatment of IPS with corticosteroids in adult HCT recipients was associated with high early response rates (>60%) compared with historical reports, with poor overall survival. The addition of etanercept did not lead to further increases in response, although the sample size of this truncated trial preclude a definitive conclusion.
- Subjects :
- Adult
Male
medicine.medical_specialty
Bone marrow transplantation
IPS
TNF
Placebo-controlled study
Lung injury
Placebo
Gastroenterology
Article
Receptors, Tumor Necrosis Factor
Etanercept
Young Adult
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Adrenal Cortex Hormones
Idiopathic pneumonia syndrome
Internal medicine
medicine
Humans
Transplantation, Homologous
Idiopathic Interstitial Pneumonias
Idiopathic interstitial pneumonia
Aged
Transplantation
business.industry
Hematopoietic Stem Cell Transplantation
Pneumonia
Pulmonary
Hematology
Middle Aged
medicine.disease
3. Good health
Surgery
Discontinuation
Treatment Outcome
Immunoglobulin G
030220 oncology & carcinogenesis
Female
business
030215 immunology
medicine.drug
Subjects
Details
- ISSN :
- 10838791
- Volume :
- 20
- Database :
- OpenAIRE
- Journal :
- Biology of Blood and Marrow Transplantation
- Accession number :
- edsair.doi.dedup.....96e7ddf8d6e8fb2f0e5e78a275fd4439