Budesonide Oral Suspension Significantly Improves Eosinophilic Esophagitis Histology Scoring System Results: Analyses From a 12-Week, Phase 2, Randomized, Placebo-controlled Trial
| Autor: | James Williams, Evan S. Dellon, David A. Katzka, Lan Lan, Ikuo Hirano, Margaret H. Collins |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Budesonide
Adult Male medicine.medical_specialty Adolescent Placebo-controlled study Anti-Inflammatory Agents Administration Oral Placebo Gastroenterology Severity of Illness Index Pathology and Forensic Medicine law.invention 03 medical and health sciences Young Adult 0302 clinical medicine Randomized controlled trial Double-Blind Method Suspensions law Internal medicine Severity of illness Medicine Humans Eosinophilic esophagitis Child business.industry Eosinophilic Esophagitis Eosinophil medicine.disease humanities Clinical trial medicine.anatomical_structure Treatment Outcome 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology Surgery Female Esophagoscopy Anatomy business medicine.drug |
| Zdroj: | The American journal of surgical pathology. 43(11) |
| ISSN: | 1532-0979 |
| Popis: | Budesonide oral suspension (BOS) is a novel topical corticosteroid, which has been shown to improve symptoms and endoscopic appearance, and reduce peak eosinophil counts in patients with eosinophilic esophagitis (EoE). This trial evaluated the effect of BOS or placebo on the severity (grade) and extent (stage) of 8 histopathologic features observed in EoE, using the validated eosinophilic esophagitis histologic scoring system (EoE HSS). Patients with EoE aged 11 to 40 years with dysphagia were randomized to receive either BOS (2.0 mg twice daily) or placebo for 12 weeks. Mean (SD) EoE HSS grade and stage total scores at baseline for placebo and BOS groups were: grade, 0.42 (0.16) and 0.49 (0.14), respectively; stage: 0.38 (0.14) and 0.46 (0.11), respectively. These scores significantly decreased (improved) from baseline for patients receiving BOS versus placebo (grade: least squares mean change [SE]: placebo vs. BOS, -0.04 [0.03] vs. -0.24 [0.02]; P0.0001; stage: -0.01 [0.02] vs. -0.19 [0.02]; P0.0001). EoE HSS total scores improved for 6 of the 8 and 5 of the 8 histopathologic features for grade and stage, respectively, versus placebo. Change in EoE HSS total scores correlated moderately but significantly with change in endoscopic severity (endoscopic reference score; grade: R=0.5349; stage: R=0.5416; both P0.0001). Change in EoE HSS stage total score correlated weakly with change in Dysphagia Symptom Questionnaire scores (grade: R=0.1925; P=0.0740; stage: R=0.2135; P=0.0471). These data demonstrate that the EoE HSS is a valuable endpoint of treatment response in randomized clinical trials and should be considered for future trials for EoE. |
| Databáze: | OpenAIRE |
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