TY - JOUR
T1 - Effect of Topical Beclomethasone on Inflammatory Markers in Adults with Eosinophilic Esophagitis
T2 - A Pilot Study
AU - Bhardwaj, Neeti
AU - Ishmael, Faoud
AU - Lehman, Erik
AU - Bethards, Deborah
AU - Ruggiero, Francesca
AU - Ghaffari, Gisoo
N1 - Funding Information:
This study was sponsored by the Foundation of Young Faculty Award of the American College of Allergy, Asthma and Immunology. The study drug, BDP, and a matching placebo were provided by the Department of Public Health, Penn State University. The study protocol was approved by institutional review board of Penn State College of Medicine, Hershey, Pennsylvania. The study protocol was approved by the Penn State's Human Subjects Protection Office (ID 32508). The study is registered in an online public database. G. Ghaffari, the principal investigator, contributed to the design and methodology, organized the research team, prepared the initial draft, and approved the final manuscript; N. Bhardwaj is the first author and the corresponding author, contributed to preparation of the draft, updated the references, and approved the final draft; F. Ishmael contributed to the methodology, evaluated and interpreted the immunologic studies, and approved the final draft; E. Lehman contributed to the methodology and statistical analysis, and approved the final draft; D. Bethards contributed to the methodology, performed all the endoscopies, and approved the final draft; F. Ruggiero contributed to the methodology, evaluated and interpreted the pathologic findings, and approved the final draft.
Publisher Copyright:
© 2017 SAGE Publications Inc.
PY - 2017
Y1 - 2017
N2 - Background: Topical corticosteroids have proven efficacy in the treatment of eosinophilic esophagitis (EoE) and are considered the cornerstone of therapy. Objective: To evaluate the effect of topical beclomethasone dipropionate (BDP) therapy on clinical outcomes, esophageal eosinophilia, and other markers of inflammation in patients with EoE. Methods: Nine subjects with a biopsy-proven diagnosis of EoE were enrolled. In a cross-over design, the subjects were randomly assigned to a sequence of BDP and placebo. Treatment periods were 8 weeks, with a 4-week washout period. The subjects had endoscopic biopsies and blood tests at baseline and after each treatment period. They were instructed to maintain a diary of symptoms. Immuno-histochemical studies were performed for interleukins IL-4, IL-5, IL-13, granulocyte-macrophage colony-stimulating factor (GM-CSF), and transforming growth factor (TGF) beta. Reverse transcription polymerase chain reaction was performed for IL-3, IL-4, IL-5, IL-10, IL-13, IL-17F, IL-25, IL-33, chemokine ligands (CCL)2, CCL5, CCL11, GM-CSF, and TGF-beta levels. The mast cell tryptase (MCT) level was measured in esophageal tissues. Results: BDP led to a significantly larger decrease in esophageal eosinophilia compared with placebo, but there was no significant change in peripheral eosinophilia and high-sensitivity C-reactive protein between the two groups. The study was not powered enough for us to report a significant improvement in clinical symptoms. There was a significant decrease in tissue IL-13 and MCT levels from baseline to the end of treatment between the treatment and placebo groups. Mean fold decreases in cytokine expression between the baseline and treatment groups were observed for IL-17F, IL-25, CCL2, and CCL5. Conclusion: Treatment with topical BDP was associated with significant decrease in esophageal eosinophilia, MCT and IL-13. BDP is a potential alternative to fluticasone propionate and budesonide for treatment of EoE. Larger studies are needed to validate these findings.
AB - Background: Topical corticosteroids have proven efficacy in the treatment of eosinophilic esophagitis (EoE) and are considered the cornerstone of therapy. Objective: To evaluate the effect of topical beclomethasone dipropionate (BDP) therapy on clinical outcomes, esophageal eosinophilia, and other markers of inflammation in patients with EoE. Methods: Nine subjects with a biopsy-proven diagnosis of EoE were enrolled. In a cross-over design, the subjects were randomly assigned to a sequence of BDP and placebo. Treatment periods were 8 weeks, with a 4-week washout period. The subjects had endoscopic biopsies and blood tests at baseline and after each treatment period. They were instructed to maintain a diary of symptoms. Immuno-histochemical studies were performed for interleukins IL-4, IL-5, IL-13, granulocyte-macrophage colony-stimulating factor (GM-CSF), and transforming growth factor (TGF) beta. Reverse transcription polymerase chain reaction was performed for IL-3, IL-4, IL-5, IL-10, IL-13, IL-17F, IL-25, IL-33, chemokine ligands (CCL)2, CCL5, CCL11, GM-CSF, and TGF-beta levels. The mast cell tryptase (MCT) level was measured in esophageal tissues. Results: BDP led to a significantly larger decrease in esophageal eosinophilia compared with placebo, but there was no significant change in peripheral eosinophilia and high-sensitivity C-reactive protein between the two groups. The study was not powered enough for us to report a significant improvement in clinical symptoms. There was a significant decrease in tissue IL-13 and MCT levels from baseline to the end of treatment between the treatment and placebo groups. Mean fold decreases in cytokine expression between the baseline and treatment groups were observed for IL-17F, IL-25, CCL2, and CCL5. Conclusion: Treatment with topical BDP was associated with significant decrease in esophageal eosinophilia, MCT and IL-13. BDP is a potential alternative to fluticasone propionate and budesonide for treatment of EoE. Larger studies are needed to validate these findings.
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U2 - 10.2500/ar.2017.8.0202
DO - 10.2500/ar.2017.8.0202
M3 - Article
AN - SCOPUS:85053628824
SN - 2152-6575
VL - 8
JO - Allergy and Rhinology
JF - Allergy and Rhinology
IS - 2
ER -