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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\u003Cp id=\u0022p-1\u0022\u003EIn a randomized placebo-controlled trial, adults and adolescents with active EoE both histologically and symptomatically were given either oral budesonide or placebo for 12 weeks. Using a validated symptom tool and biopsy data, the results suggest a significant improvement in both symptoms and histology among those in the budesonide group, with no impending safety signals.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Ebudesonide\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Edysphagia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eeosinophilia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eesophageal eosinophilia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDysphagia Symptom Questionnaire\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT01642212\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Egastroenterology clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EEosinophilic esophagitis (EoE) is a condition defined by symptoms of dysphagia or esophageal dysfunction, and an eosinophilic infiltrate that persists even after a trial of proton pump inhibitors. Evan Dellon, MD, MPH, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA, reviewed data from a clinical trial [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01642212\u0026amp;atom=%2Fspmdc%2F15%2F14%2F16.atom\u0022\u003ENCT01642212\u003C\/a\u003E] comparing oral budesonide (OBS) with placebo in adolescents and adults with EoE.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ETypical first-line medications for EoE include swallowed topical corticosteroids such as fluticasone or budesonide. Although observational data and randomized clinical trials support the use of these agents [Dellon ES, Liacouras CA. \u003Cem\u003EGastroenterology\u003C\/em\u003E. 2014; Liacouras CA et al. \u003Cem\u003EJ Allergy Clin Immunol\u003C\/em\u003E. 2011], neither is FDA approved for the indication of EoE. In addition, neither of these drugs has been assessed in patients using a validated measure of patient-reported outcomes.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThis randomized, double-blind, multicenter placebo-controlled trial was designed to determine whether OBS was superior to placebo in generating both a histologic and a symptomatic response. Histologic response was measured by a finding of \u2264\u20056 eosinophils\/high-power field (HPF); symptom response was measured using the Dysphagia Symptom Questionnaire (DSQ) over the 16-week course of therapy. The DSQ is a daily diary that asks 3 questions relative to a patient\u2019s symptoms and has been validated for dysphagia frequency and severity in patients with EoE [Dellon ES et al. \u003Cem\u003EAliment Pharmacol Ther\u003C\/em\u003E. 2013]. The histology assessment was based on biopsies obtained from the proximal, mid, and distal esophagus. All patients had a confirmed diagnosis of EoE per the 2011 updated consensus guidelines [Liacouras CA et al. \u003Cem\u003EJ Allergy Clin Immunol\u003C\/em\u003E. 2011].\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EInclusion criteria included patients aged 11 to 40 years with a confirmed diagnosis of EoE, biopsy findings of \u2265\u200515 eosinophils\/HPF at 2 esophageal levels, \u2265\u20054 days of dysphagia over 2 weeks during the 4-week blinded placebo run-in portion of the trial, and 70% completion of the DSQ. Key exclusion criteria included the presence of other gastrointestinal diseases, use of steroids within 4 weeks of the screening endoscopy, tight esophageal stricture, or pregnancy.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EAfter a baseline endoscopy and biopsy, patients entered a 4-week placebo run-in period and their symptoms were assessed. Patients who met the symptom and biopsy criteria at that time were randomized to either OBS 2 mg\/10 mL BID (n\u2005=\u200551) or placebo suspension for 12 weeks (n\u2005=\u200542); an open-label extension was also planned for an additional 24 weeks. Dr Dellon emphasized that this was a highly symptomatic and inflamed study group, with a mean DSQ score of 29 to 30 and a mean overall eosinophil count of 130 (placebo) and 156 (OBS).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EFollowing the end of treatment, endoscopy and biopsy were reperformed. The coprimary outcomes were change in the DSQ from baseline and the proportion of patients with a histologic response defined as \u2264\u20056 eosinophils\/HPF. Safety and adverse events were also monitored.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThere were significant differences favoring OBS vs placebo in both the DSQ scores (\u003Cem\u003EP\u2005\u003C\/em\u003E=\u2005.0096) and the histology results (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.0001). Although the most common adverse event among both groups was nasopharyngitis, there were no safety signals evident in either group. In addition, although these results are encouraging, Dr Dellon noted several limitations to the study, including the short treatment course and the restricted age range of the patients.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/15\/14\/16.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzlhj1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}