Safety and Efficacy of Budesonide Oral Suspension Maintenance Therapy in Patients With Eosinophilic Esophagitis

Evan S. Dellon, David A Katzka, Margaret H. Collins, Sandeep K. Gupta, Lan Lan, James Williams, Ikuo Hirano

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background & Aims: We aimed to determine the safety and efficacy of budesonide oral suspension (BOS) maintenance therapy in patients with eosinophilic esophagitis (EoE). Methods: We performed an open-label extension study of a 12-week, multicenter, randomized, double-blind, placebo-controlled trial. Patients with EoE (11–40 years old) who completed double-blind BOS (n = 45) or placebo therapy (n = 37) received 24 weeks’ open-label BOS (2.0 mg once daily for 12 weeks, with optional dose increase [1.5–2.0 mg twice daily] for 12 weeks thereafter). Predefined efficacy outcomes included: proportion of patients with a histologic response (≤6 eosinophils/high-power field [eos/hpf]) and change in mean peak eosinophil counts after 24 weeks. Analyses were stratified by patients who received placebo (placebo/BOS) or BOS (BOS/BOS) during the double-blind trial. Results: BOS was well tolerated and drug-related adverse events were uncommon (placebo/BOS, 19% [7/37]; BOS/BOS, 4% [2/45]). Incidence of oral candidiasis (1 per group) and esophageal candidiasis (placebo/BOS group, n = 4) remained low. Changes in morning serum cortisol levels were not clinically relevant. A histologic response was observed in 49% (16/33) of patients receiving placebo/BOS and 23% (9/39) receiving BOS/BOS. Mean peak eosinophil counts (baseline vs week 24 or early termination) were: placebo/BOS, 118.8 vs 29.1; P <.001 and BOS/BOS, 38.1 vs 72.4; P =.01. Of the patients who responded to double-blind therapy, 42% maintained a histologic response during the open-label extension; 4% of nonresponders gained response. Conclusions: In an open-label extension study of patients with EoE, BOS was well tolerated and drug-related adverse events were uncommon. BOS maintained a histologic response in some initial responders, but few initial nonresponders had a response. ClinicalTrials.gov no: NCT01642212.

Original languageEnglish (US)
JournalClinical Gastroenterology and Hepatology
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Eosinophilic Esophagitis
Budesonide
Suspensions
Safety
Placebos
Therapeutics
Eosinophils
Drug-Related Side Effects and Adverse Reactions

Keywords

  • Clinical Trial
  • Corticosteroid
  • Esophagus
  • Treatment

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Safety and Efficacy of Budesonide Oral Suspension Maintenance Therapy in Patients With Eosinophilic Esophagitis. / Dellon, Evan S.; Katzka, David A; Collins, Margaret H.; Gupta, Sandeep K.; Lan, Lan; Williams, James; Hirano, Ikuo.

In: Clinical Gastroenterology and Hepatology, 01.01.2019.

Research output: Contribution to journalArticle

Dellon, Evan S. ; Katzka, David A ; Collins, Margaret H. ; Gupta, Sandeep K. ; Lan, Lan ; Williams, James ; Hirano, Ikuo. / Safety and Efficacy of Budesonide Oral Suspension Maintenance Therapy in Patients With Eosinophilic Esophagitis. In: Clinical Gastroenterology and Hepatology. 2019.
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abstract = "Background & Aims: We aimed to determine the safety and efficacy of budesonide oral suspension (BOS) maintenance therapy in patients with eosinophilic esophagitis (EoE). Methods: We performed an open-label extension study of a 12-week, multicenter, randomized, double-blind, placebo-controlled trial. Patients with EoE (11–40 years old) who completed double-blind BOS (n = 45) or placebo therapy (n = 37) received 24 weeks’ open-label BOS (2.0 mg once daily for 12 weeks, with optional dose increase [1.5–2.0 mg twice daily] for 12 weeks thereafter). Predefined efficacy outcomes included: proportion of patients with a histologic response (≤6 eosinophils/high-power field [eos/hpf]) and change in mean peak eosinophil counts after 24 weeks. Analyses were stratified by patients who received placebo (placebo/BOS) or BOS (BOS/BOS) during the double-blind trial. Results: BOS was well tolerated and drug-related adverse events were uncommon (placebo/BOS, 19{\%} [7/37]; BOS/BOS, 4{\%} [2/45]). Incidence of oral candidiasis (1 per group) and esophageal candidiasis (placebo/BOS group, n = 4) remained low. Changes in morning serum cortisol levels were not clinically relevant. A histologic response was observed in 49{\%} (16/33) of patients receiving placebo/BOS and 23{\%} (9/39) receiving BOS/BOS. Mean peak eosinophil counts (baseline vs week 24 or early termination) were: placebo/BOS, 118.8 vs 29.1; P <.001 and BOS/BOS, 38.1 vs 72.4; P =.01. Of the patients who responded to double-blind therapy, 42{\%} maintained a histologic response during the open-label extension; 4{\%} of nonresponders gained response. Conclusions: In an open-label extension study of patients with EoE, BOS was well tolerated and drug-related adverse events were uncommon. BOS maintained a histologic response in some initial responders, but few initial nonresponders had a response. ClinicalTrials.gov no: NCT01642212.",
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T1 - Safety and Efficacy of Budesonide Oral Suspension Maintenance Therapy in Patients With Eosinophilic Esophagitis

AU - Dellon, Evan S.

AU - Katzka, David A

AU - Collins, Margaret H.

AU - Gupta, Sandeep K.

AU - Lan, Lan

AU - Williams, James

AU - Hirano, Ikuo

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background & Aims: We aimed to determine the safety and efficacy of budesonide oral suspension (BOS) maintenance therapy in patients with eosinophilic esophagitis (EoE). Methods: We performed an open-label extension study of a 12-week, multicenter, randomized, double-blind, placebo-controlled trial. Patients with EoE (11–40 years old) who completed double-blind BOS (n = 45) or placebo therapy (n = 37) received 24 weeks’ open-label BOS (2.0 mg once daily for 12 weeks, with optional dose increase [1.5–2.0 mg twice daily] for 12 weeks thereafter). Predefined efficacy outcomes included: proportion of patients with a histologic response (≤6 eosinophils/high-power field [eos/hpf]) and change in mean peak eosinophil counts after 24 weeks. Analyses were stratified by patients who received placebo (placebo/BOS) or BOS (BOS/BOS) during the double-blind trial. Results: BOS was well tolerated and drug-related adverse events were uncommon (placebo/BOS, 19% [7/37]; BOS/BOS, 4% [2/45]). Incidence of oral candidiasis (1 per group) and esophageal candidiasis (placebo/BOS group, n = 4) remained low. Changes in morning serum cortisol levels were not clinically relevant. A histologic response was observed in 49% (16/33) of patients receiving placebo/BOS and 23% (9/39) receiving BOS/BOS. Mean peak eosinophil counts (baseline vs week 24 or early termination) were: placebo/BOS, 118.8 vs 29.1; P <.001 and BOS/BOS, 38.1 vs 72.4; P =.01. Of the patients who responded to double-blind therapy, 42% maintained a histologic response during the open-label extension; 4% of nonresponders gained response. Conclusions: In an open-label extension study of patients with EoE, BOS was well tolerated and drug-related adverse events were uncommon. BOS maintained a histologic response in some initial responders, but few initial nonresponders had a response. ClinicalTrials.gov no: NCT01642212.

AB - Background & Aims: We aimed to determine the safety and efficacy of budesonide oral suspension (BOS) maintenance therapy in patients with eosinophilic esophagitis (EoE). Methods: We performed an open-label extension study of a 12-week, multicenter, randomized, double-blind, placebo-controlled trial. Patients with EoE (11–40 years old) who completed double-blind BOS (n = 45) or placebo therapy (n = 37) received 24 weeks’ open-label BOS (2.0 mg once daily for 12 weeks, with optional dose increase [1.5–2.0 mg twice daily] for 12 weeks thereafter). Predefined efficacy outcomes included: proportion of patients with a histologic response (≤6 eosinophils/high-power field [eos/hpf]) and change in mean peak eosinophil counts after 24 weeks. Analyses were stratified by patients who received placebo (placebo/BOS) or BOS (BOS/BOS) during the double-blind trial. Results: BOS was well tolerated and drug-related adverse events were uncommon (placebo/BOS, 19% [7/37]; BOS/BOS, 4% [2/45]). Incidence of oral candidiasis (1 per group) and esophageal candidiasis (placebo/BOS group, n = 4) remained low. Changes in morning serum cortisol levels were not clinically relevant. A histologic response was observed in 49% (16/33) of patients receiving placebo/BOS and 23% (9/39) receiving BOS/BOS. Mean peak eosinophil counts (baseline vs week 24 or early termination) were: placebo/BOS, 118.8 vs 29.1; P <.001 and BOS/BOS, 38.1 vs 72.4; P =.01. Of the patients who responded to double-blind therapy, 42% maintained a histologic response during the open-label extension; 4% of nonresponders gained response. Conclusions: In an open-label extension study of patients with EoE, BOS was well tolerated and drug-related adverse events were uncommon. BOS maintained a histologic response in some initial responders, but few initial nonresponders had a response. ClinicalTrials.gov no: NCT01642212.

KW - Clinical Trial

KW - Corticosteroid

KW - Esophagus

KW - Treatment

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