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      A 12-Week Maintenance Therapy with a New Prepared Viscous Budesonide in Pediatric Eosinophilic Esophagitis

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          Abstract

          Background

          A new prepared oral viscous budesonide (PVB) has been effective in inducing clinical and histological remission in pediatric eosinophilic esophagitis (EoE).

          Aims

          To evaluate the efficacy of a 12-week maintenance therapy on clinical, endoscopic, and histological remission using half of the dose used in the induction therapy.

          Methods

          We prospectively enrolled pediatric patients with active EoE. After 12 weeks of induction therapy with PVB (< 150 cm: 2 mg/day; ≥ 150 cm: 4 mg/day) patients received a maintenance dose of half of the dose used in the induction therapy (1 mg or 2 mg) for another 12 weeks. A 12-week follow-up was then performed in all patients after the end of therapy. Endoscopy was performed at weeks 0, 12, 24, and 36. Symptoms, endoscopy, and histology scores were also calculated. Serum cortisol was evaluated during the treatment period.

          Results

          We enrolled 20 children (15 males; median age 10 years; range 4–17). After the 12-week induction therapy 18 patients (90%) were in remission, with a significant decrease in the median peak of eosinophil count/HPF as well as a marked reduction in clinical, endoscopic, and histological scores ( p < 0.01). At the end of the maintenance therapy (week 24), 17 patients (85%) were still in remission, while there were only 9 at week 36 (45%). No significant changes in cortisol levels were observed during the study period.

          Conclusions

          The 12-week maintenance treatment with the half the dose of PVB was effective in sustaining remission at week 24; however, no reduction in the rate of relapse after suspension of treatment occurred.

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          Most cited references 26

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          Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial.

          Eosinophilic esophagitis (EoE) is caused by immunologic reactions to ingested/inhaled allergens. The diagnosis is considered if >or=15 eosinophils per high-powered field (eos/hpf) are detected in mucosal biopsies. Placebo-controlled studies have not been conducted to evaluate the safety and efficacy of oral viscous budesonide (OVB). Children with EoE were randomly assigned to groups that were given OVB (n=15) or placebo (n=9). Patients or=5 feet tall received 1 mg and 2 mg OVB daily, respectively. All patients received lansoprazole. Duration of treatment was 3 months, followed by repeat endoscopy and biopsies. Patients were classified as responders if their peak eosinophil counts were or=20 eos/hpf. Baseline and post-treatment symptoms and endoscopic and histologic features were scored. Thirteen (86.7%) children given OVB (P<.0001) and none who received placebo (P=.3) were classified as responders. Mean pre-/post-treatment peak eosinophil counts were 66.7 and 4.8 eos/hpf, respectively, in the group given OVB (P<.0001); they were 83.9 and 65.6 eos/hpf, respectively, in the group given placebo (P=.3). In the group given OVB, there were significant reductions from baseline values in proximal (P=.002), mid (P=.0003), and distal (P=.001) esophageal eosinophilia. After OVB therapy, compared with baseline, the mean symptom (P=.0007), endoscopy (P=.0005), and histology scores improved (P=.0035) significantly. OVB is an effective treatment of pan-esophageal disease in children with EoE. OVB improves symptoms and endoscopic and histologic features. Proton pump inhibitor single therapy did not significantly improve esophageal eosinophilia or symptoms of EoE. Copyright (c) 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.
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            A phenotypic analysis shows that eosinophilic esophagitis is a progressive fibrostenotic disease.

            Phenotypes of eosinophilic esophagitis (EoE) are not well-characterized.
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              Epidemiology and Natural History of Eosinophilic Esophagitis

              Eosinophilic esophagitis (EoE) has emerged over the past 2 decades as a major cause of upper gastrointestinal morbidity. Over this time, the epidemiology of EoE has also rapidly evolved. EoE has transformed from a rare case-reportable condition to disease that is commonly encountered in the gastroenterology clinic, hospital emergency room, and endoscopy suite. The incidence and prevalence are increasing at rates that outpace increased disease recognition. Current incidence estimates range from 5 to 10 cases per 100,000, and current prevalence estimates range from 0.5 to 1 case per 1000. We review the data and potential reasons behind this increase, examine risk factors, and identify important areas for research into disease etiology. The article also discusses the progression of EoE from an inflammatory to fibrostenotic phenotype. An accurate view of the natural history of EoE is central to discussions with patients regarding disease prognosis and decisions about long-term use of medical, endoscopic, and diet therapies. Progressive remodelling appears to be gradual, but not universal, and the duration of untreated disease is the best predictor of stricture risk. Ultimately, prospective, long-term outcome studies focusing on multiple aspects of disease activity are needed to fully understand the natural history of EoE.
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                Author and article information

                Contributors
                +390649979326 , salvatore.oliva@uniroma1.it
                Journal
                Dig Dis Sci
                Dig. Dis. Sci
                Digestive Diseases and Sciences
                Springer US (New York )
                0163-2116
                1573-2568
                19 January 2019
                19 January 2019
                2019
                : 64
                : 6
                : 1571-1578
                Affiliations
                [1 ]GRID grid.7841.a, Department of Pediatrics, Pediatric Gastroenterology and Liver Unit, , Sapienza University of Rome, ; Viale Regina Elena 324, 00161 Rome, Italy
                [2 ]GRID grid.7841.a, Department of Paediatrics, PICU, , Sapienza University of Rome, ; 00161 Rome, Italy
                [3 ]GRID grid.7841.a, Department of Radiological Sciences, Oncology, and Anatomical Pathology, , Sapienza – University of Rome, ; Rome, Italy
                Article
                5449
                10.1007/s10620-018-5449-x
                6522447
                30659470
                © The Author(s) 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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                © Springer Science+Business Media, LLC, part of Springer Nature 2019

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