Comparison of Oral Prednisone and Topical Fluticasone in the Treatment of Eosinophilic Esophagitis: A Randomized Trial in Children

Elizabeth T. Schaefer, Joseph F. Fitzgerald, Jean P. Molleston, Joseph M. Croffie, Marian D. Pfefferkorn, Mark R. Corkins, Joel D. Lim, Steven J. Steiner, Sandeep K. Gupta

Research output: Contribution to journalArticle

261 Citations (Scopus)

Abstract

Background & Aims: Although eosinophilic esophagitis is recognized increasingly, outcome data guiding therapy are limited. We conducted a prospective randomized trial comparing oral prednisone (P) and swallowed fluticasone (F) for histologic and clinical response. Methods: Patients were randomized to receive P or F for 4 weeks, followed by an 8-week weaning protocol. Esophageal histology was evaluated at baseline and after 4 weeks of therapy. Clinical assessments were performed at weeks 0, 4, 12, 18, and 24. Results: Eighty patients with eosinophilic esophagitis were enrolled: 40 in the P arm and 40 in the F arm. Histologic improvement was seen in 30 of 32 P and 34 of 36 F patients, with a greater degree of histologic improvement in the P group. All P and 35 of 36 F patients were free of presenting symptom(s) at week 4. Symptom relapse was seen in 45% of patients by week 24. Kaplan-Meier analysis showed no difference between P and F with regard to relapse rate (P = .7399). No significant difference in time to relapse was found between groups (P = .2529). Systemic adverse effects were noted in 40% of the P arm, whereas esophageal candidal overgrowth was seen in 15% of the F arm. Conclusions: Systemic and topical corticosteroids were effective in achieving initial histologic and clinical improvement. P resulted in a greater degree of histologic improvement, without evidence of an associated clinical advantage over F in terms of symptom resolution, relapse rates, or time to relapse. Symptom relapse was common to both groups upon therapy discontinuation, highlighting the need for maintenance treatment protocols.

Original languageEnglish (US)
Pages (from-to)165-173
Number of pages9
JournalClinical Gastroenterology and Hepatology
Volume6
Issue number2
DOIs
StatePublished - Feb 1 2008

Fingerprint

Eosinophilic Esophagitis
Prednisone
Recurrence
Therapeutics
Kaplan-Meier Estimate
Clinical Protocols
Group Psychotherapy
Weaning
Fluticasone
Histology
Adrenal Cortex Hormones

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

Cite this

Comparison of Oral Prednisone and Topical Fluticasone in the Treatment of Eosinophilic Esophagitis : A Randomized Trial in Children. / Schaefer, Elizabeth T.; Fitzgerald, Joseph F.; Molleston, Jean P.; Croffie, Joseph M.; Pfefferkorn, Marian D.; Corkins, Mark R.; Lim, Joel D.; Steiner, Steven J.; Gupta, Sandeep K.

In: Clinical Gastroenterology and Hepatology, Vol. 6, No. 2, 01.02.2008, p. 165-173.

Research output: Contribution to journalArticle

Schaefer, Elizabeth T. ; Fitzgerald, Joseph F. ; Molleston, Jean P. ; Croffie, Joseph M. ; Pfefferkorn, Marian D. ; Corkins, Mark R. ; Lim, Joel D. ; Steiner, Steven J. ; Gupta, Sandeep K. / Comparison of Oral Prednisone and Topical Fluticasone in the Treatment of Eosinophilic Esophagitis : A Randomized Trial in Children. In: Clinical Gastroenterology and Hepatology. 2008 ; Vol. 6, No. 2. pp. 165-173.
@article{96796e27fc2b4faf978fa2facaee0723,
title = "Comparison of Oral Prednisone and Topical Fluticasone in the Treatment of Eosinophilic Esophagitis: A Randomized Trial in Children",
abstract = "Background & Aims: Although eosinophilic esophagitis is recognized increasingly, outcome data guiding therapy are limited. We conducted a prospective randomized trial comparing oral prednisone (P) and swallowed fluticasone (F) for histologic and clinical response. Methods: Patients were randomized to receive P or F for 4 weeks, followed by an 8-week weaning protocol. Esophageal histology was evaluated at baseline and after 4 weeks of therapy. Clinical assessments were performed at weeks 0, 4, 12, 18, and 24. Results: Eighty patients with eosinophilic esophagitis were enrolled: 40 in the P arm and 40 in the F arm. Histologic improvement was seen in 30 of 32 P and 34 of 36 F patients, with a greater degree of histologic improvement in the P group. All P and 35 of 36 F patients were free of presenting symptom(s) at week 4. Symptom relapse was seen in 45{\%} of patients by week 24. Kaplan-Meier analysis showed no difference between P and F with regard to relapse rate (P = .7399). No significant difference in time to relapse was found between groups (P = .2529). Systemic adverse effects were noted in 40{\%} of the P arm, whereas esophageal candidal overgrowth was seen in 15{\%} of the F arm. Conclusions: Systemic and topical corticosteroids were effective in achieving initial histologic and clinical improvement. P resulted in a greater degree of histologic improvement, without evidence of an associated clinical advantage over F in terms of symptom resolution, relapse rates, or time to relapse. Symptom relapse was common to both groups upon therapy discontinuation, highlighting the need for maintenance treatment protocols.",
author = "Schaefer, {Elizabeth T.} and Fitzgerald, {Joseph F.} and Molleston, {Jean P.} and Croffie, {Joseph M.} and Pfefferkorn, {Marian D.} and Corkins, {Mark R.} and Lim, {Joel D.} and Steiner, {Steven J.} and Gupta, {Sandeep K.}",
year = "2008",
month = "2",
day = "1",
doi = "10.1016/j.cgh.2007.11.008",
language = "English (US)",
volume = "6",
pages = "165--173",
journal = "Clinical Gastroenterology and Hepatology",
issn = "1542-3565",
publisher = "W.B. Saunders Ltd",
number = "2",

}

TY - JOUR

T1 - Comparison of Oral Prednisone and Topical Fluticasone in the Treatment of Eosinophilic Esophagitis

T2 - A Randomized Trial in Children

AU - Schaefer, Elizabeth T.

AU - Fitzgerald, Joseph F.

AU - Molleston, Jean P.

AU - Croffie, Joseph M.

AU - Pfefferkorn, Marian D.

AU - Corkins, Mark R.

AU - Lim, Joel D.

AU - Steiner, Steven J.

AU - Gupta, Sandeep K.

PY - 2008/2/1

Y1 - 2008/2/1

N2 - Background & Aims: Although eosinophilic esophagitis is recognized increasingly, outcome data guiding therapy are limited. We conducted a prospective randomized trial comparing oral prednisone (P) and swallowed fluticasone (F) for histologic and clinical response. Methods: Patients were randomized to receive P or F for 4 weeks, followed by an 8-week weaning protocol. Esophageal histology was evaluated at baseline and after 4 weeks of therapy. Clinical assessments were performed at weeks 0, 4, 12, 18, and 24. Results: Eighty patients with eosinophilic esophagitis were enrolled: 40 in the P arm and 40 in the F arm. Histologic improvement was seen in 30 of 32 P and 34 of 36 F patients, with a greater degree of histologic improvement in the P group. All P and 35 of 36 F patients were free of presenting symptom(s) at week 4. Symptom relapse was seen in 45% of patients by week 24. Kaplan-Meier analysis showed no difference between P and F with regard to relapse rate (P = .7399). No significant difference in time to relapse was found between groups (P = .2529). Systemic adverse effects were noted in 40% of the P arm, whereas esophageal candidal overgrowth was seen in 15% of the F arm. Conclusions: Systemic and topical corticosteroids were effective in achieving initial histologic and clinical improvement. P resulted in a greater degree of histologic improvement, without evidence of an associated clinical advantage over F in terms of symptom resolution, relapse rates, or time to relapse. Symptom relapse was common to both groups upon therapy discontinuation, highlighting the need for maintenance treatment protocols.

AB - Background & Aims: Although eosinophilic esophagitis is recognized increasingly, outcome data guiding therapy are limited. We conducted a prospective randomized trial comparing oral prednisone (P) and swallowed fluticasone (F) for histologic and clinical response. Methods: Patients were randomized to receive P or F for 4 weeks, followed by an 8-week weaning protocol. Esophageal histology was evaluated at baseline and after 4 weeks of therapy. Clinical assessments were performed at weeks 0, 4, 12, 18, and 24. Results: Eighty patients with eosinophilic esophagitis were enrolled: 40 in the P arm and 40 in the F arm. Histologic improvement was seen in 30 of 32 P and 34 of 36 F patients, with a greater degree of histologic improvement in the P group. All P and 35 of 36 F patients were free of presenting symptom(s) at week 4. Symptom relapse was seen in 45% of patients by week 24. Kaplan-Meier analysis showed no difference between P and F with regard to relapse rate (P = .7399). No significant difference in time to relapse was found between groups (P = .2529). Systemic adverse effects were noted in 40% of the P arm, whereas esophageal candidal overgrowth was seen in 15% of the F arm. Conclusions: Systemic and topical corticosteroids were effective in achieving initial histologic and clinical improvement. P resulted in a greater degree of histologic improvement, without evidence of an associated clinical advantage over F in terms of symptom resolution, relapse rates, or time to relapse. Symptom relapse was common to both groups upon therapy discontinuation, highlighting the need for maintenance treatment protocols.

UR - http://www.scopus.com/inward/record.url?scp=38649107039&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=38649107039&partnerID=8YFLogxK

U2 - 10.1016/j.cgh.2007.11.008

DO - 10.1016/j.cgh.2007.11.008

M3 - Article

C2 - 18237866

AN - SCOPUS:38649107039

VL - 6

SP - 165

EP - 173

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

SN - 1542-3565

IS - 2

ER -