Budesonide Orodispersible Tablets are Highly Effective for Treatment of Active Eosinophilic Esophagitis: Results from a Randomized, Double-Blind, Placebo-Controlled, Pivotal Multicenter Trial (EOS-1)

Compounded Oral Viscous Budesonide is Effective and Provides a Durable Response in Eosinophilic Esophagitis

“…[29] More recent studies have suggested that the formulation and/or preparation is of paramount importance for the efficacy of the corticosteroid. [9,17,30,31] One study showed that an effervescent budesonide tablet is effective as a delivery vehicle in a phase 2 placebo-controlled RCT, [30] and this medication also proved highly efficacious in a phase 3 trial. [31] An additional phase 2 RCT found a muco-adherent viscous budesonide formulation to be effective in improving the clinical, endoscopic and histologic features of the disease.…”

Overview of eosinophilic oesophagitis

“…An approved topical steroid has become available for patients with eosinophilic oesophagitis (Miehlke et al, 2016;Lucendo et al, 2017b). This treatment (Jorveza) is an oro-dispersible tablet held in the mouth on the tongue, taken at a time when there is no plan to eat or drink anything that might wash it away from the surface of the oesophagus.…”

Heterogeneity in Clinical, Endoscopic, and Histologic Outcome Measures and Placebo Response Rates in Clinical Trials of Eosinophilic Esophagitis: A Systematic Review

“…Fourteen studies reported change in absolute eosinophil counts before and after therapy or by percentage changes from baseline in eosinophil density. 23,24,[26][27][28][29][30]32,33,35,[37][38][39][40] One study used the EoE Histology Scoring System (EoE-HSS) to evaluate both severity and extent of 8 features (eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis). 38 Four studies specified that histologic outcomes required changes at multiple esophageal levels (eg, proximal and distal esophagus).…”

“…Multiple different scoring systems, mostly non-validated or only partially validated, have been used to assess patient-reported response or remission. These include the Mayo Dysphagia Questionnaire, 24,30,34 the Dysphagia Symptom Questionnaire, 36 the EoE Activity Index (EEsAI), 40 patient or physician global assessments of disease severity, 26,32,37,40 the Dysphagia Score (also termed the Straumann Dysphagia Index), [21][22][23] the EoE Clinical Symptom Score, 28,31 the Pediatric Eosinophilic Esophagitis Symptom Score, 20 and the Visual Dysphagia Questionnaire. 27 As with endoscopy and histology endpoints, no uniformly applied thresholds for patientreported remission or response have been identified, although the complete absence of symptoms has been used by some authors to define remission.…”

“…Eight studies reported histologic placebo remission rates of 0%. 20,21,23,24,28,33,39,40 When assessed as a continuous measure relative to the scale of the measurement tool, endoscopy scores before and after placebo administration changed between -0.6% to -16%. Larger variances were evident when assessing patient-reported placebo response ( Figure 2); patient-reported scores before and after placebo administration varied between -28.6% to þ36.6%.…”