Budesonide Oral Suspension Improves Symptomatic, Endoscopic, and Histologic Parameters Compared With Placebo in Patients With Eosinophilic Esophagitis

Collins, Margaret H.; Hamdani, Mohamed; Kagalwalla, Amir F.; Lewis, Jeffrey D.; Markowitz, Jonathan E.; Nurko, Samuel; Wo, John M.; Dellon, Evan S.; Gunasekaran, Thirumazhisai S.; Hirano, Ikuo; Gupta, Sandeep K.; Pasternak, Brad; Ellis, Mark; Peterson, Kathryn A.; Falk, Gary W.; Leung, John; Prestridge, Laurel L.; Hart, Michael H.; Leleiko, Neal S.; Vaezi, Michael F.; Cherry, Rebecca; Katzka, David A.; Friedenberg, Keith; Assouline-Dayan, Yehudith; Mukkada, Vincent A.

doi:10.1053/j.gastro.2016.11.021

Cited by 175 publications

(223 citation statements)

References 49 publications

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“…2,3 Since then several studies in adults have demonstrated that this metric is highly predictive of EoE diagnosis and responsive to treatment. 4–7 …”

mentioning

confidence: 99%

Eosinophilic Esophagitis Reference Score Accurately Identifies Disease Activity and Treatment Effects in Children

Wechsler

Bolton

Amsden

et al. 2018

Clinical Gastroenterology and Hepatology

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BACKGROUND & AIMS The endoscopic reference score (EREFS) is used to determine severity of 5 endoscopic findings: edema, rings, exudates, furrows, and strictures. Little is known about the relationship between EREFSs and histologic markers of disease activity in children with eosinophilic esophagitis (EoE). We aimed to determine whether the EREFS can be used to identify children with EoE and how it changes with treatment. METHODS We performed a prospective study of consecutive children (ages 2–17 years) undergoing diagnostic or post-treatment endoscopy scored real-time with EREFS from December 2012 through 2016. Findings from 192 diagnostic endoscopies and 229 post-treatment endoscopies were evaluated, from 371 children. Incident EoE cases were diagnosed based on 2011 consensus guidelines. Patients were treated with either elimination diet or topical steroids. Subjects who underwent endoscopy for symptoms of esophageal dysfunction but had normal esophageal findings from histology analysis were used as controls. EREFS and receiver operating characteristic curves were determined for incident EoE cases (n = 77) vs controls (n = 115), patients with active EoE (n = 101) vs inactive EoE after treatment (n = 128), and paired pre- and post-treatment cases of EoE (n = 85). Component and composite scores were correlated with eosinophilia. RESULTS Visual detection of more than 1 esophageal abnormality during the diagnostic endoscopy identified children with EoE with 89.6% sensitivity and 87.9% specificity. EREFS correlated with peak level of eosinophilia (P < .001) at all esophageal levels. Children who responded to therapy had mean EREFSs of 0.5 compared to 2.4 in non-responders. In comparing pre-treatment vs post-treatment data from 85 patients, we found a significant reduction in the composite EREFS (from 2.4 to 0.7) (P < .001) among patients who responded to treatment; 92% of responders had a reduced EREFSs after treatment. EREFSs identified children with EoE with an area under the curve value (AUC) of 0.93. EREFSs identified children with active EoE following treatment with an AUC of 0.81 before treatment and an AUC of 0.79 after treatment. CONCLUSIONS In a prospective study of children undergoing diagnostic or post-treatment endoscopy, we found the EREFS to accurately identify those with EoE. Children who responded to therapy had lower EREFS scores than non-responders. EREFSs can be used to measure outcomes of pediatric patients, in conjunction with histology findings, and assess treatments for children with EoE.

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“…2,3 Since then several studies in adults have demonstrated that this metric is highly predictive of EoE diagnosis and responsive to treatment. 4–7 …”

mentioning

confidence: 99%

Eosinophilic Esophagitis Reference Score Accurately Identifies Disease Activity and Treatment Effects in Children

Wechsler

Bolton

Amsden

et al. 2018

Clinical Gastroenterology and Hepatology

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“…In the second, a budesonide oral suspension was compared to placebo. (45) Here, 39% in the budesonide arm had a histologic response compared to 3% in placebo, but there were associated symptomatic and endoscopic improvements in these patients, measured for the first time using validated instruments. Both of these agents are currently in phase 3 trials and show the importance of developing medications to maximize esophageal deposition, but also of including specific study design elements that enhance measurement of the primary endpoints.…”

Section: Treatment Of Eoe: Current Status Of Drug Developmentmentioning

confidence: 87%

“…Responsiveness to change in the context of a placebo-controlled trial of BOS demonstrated the ability of the instrument to detect change in symptom activity. (45) A second PRO instrument, the EoE Activity Index (EEsAI), was developed and validated for use in adults by an international collaboration led by a Swiss group. (70) In addition to questions about the frequency and intensity of dysphagia, the EEsAI incorporated a novel, “visual dysphagia questionnaire” that asks patients about food avoidance and modification behaviors.…”

Section: Treatment Of Eoe: Current Status Of Drug Developmentmentioning

confidence: 99%

White Paper AGA: Drug Development for Eosinophilic Esophagitis

Hirano

Spechler

Furuta

et al. 2017

Clinical Gastroenterology and Hepatology

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“…A phase II multicenter trial using budesonide oral suspension in 93 patients showed that this treatment significantly improved symptomatic, endoscopic, and histologic parameters compared with placebo. 175 A multicenter phase III trial is currently under way.…”

Section: Esophageal Dilatationmentioning

confidence: 99%

Eosinophilic esophagitis: update on management and controversies

Chen

Kao

2017

BMJ

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Eosinophilic esophagitis is a chronic allergen driven immune mediated disease that is increasingly recognized as a leading cause of dysphagia and foregut symptoms in children and adults. Much knowledge has been gained in recent years on the genetic and environmental risk factors for this disease, the associated inflammatory milieu, and the long term complications from esophageal remodeling. In this review we will highlight recent progress made in research into this disease, focusing on adults. We will discuss ongoing efforts to develop a minimally invasive technique that may obviate the need for repeated endoscopic assessment of disease activity. Moreover, we will review studies using novel tools such as mucosal impedance and functional lumen imaging as potential surrogate markers for mucosal integrity and esophageal remodeling. With regard to the treatment of eosinophilic inflammation, we will discuss the controversies surrounding responsiveness to proton pump inhibitors in some patients. Therapeutic trials continue to support the use of topical glucocorticoids and empiric food elimination diets as first line treatments. We will discuss ongoing efforts to optimize the elimination diet protocol to decrease the level and duration of food restrictions. Looking ahead, our growing knowledge on the pathogenesis of eosinophilic esophagitis has enabled further advancement of promising targeted biologic therapies.

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Budesonide Oral Suspension Improves Symptomatic, Endoscopic, and Histologic Parameters Compared With Placebo in Patients With Eosinophilic Esophagitis

Abstract: Treatment with BOS was well tolerated in adolescent and young adult patients with EoE and resulted in improvement in symptomatic, endoscopic, and histologic parameters using validated outcome instruments. ClinicalTrials.gov ID NCT01642212.

Cited by 175 publications

References 49 publications

Eosinophilic Esophagitis Reference Score Accurately Identifies Disease Activity and Treatment Effects in Children

Eosinophilic Esophagitis Reference Score Accurately Identifies Disease Activity and Treatment Effects in Children

White Paper AGA: Drug Development for Eosinophilic Esophagitis

Eosinophilic esophagitis: update on management and controversies

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