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Published on: March 22, 2017
Real-world experience of budesonide orodispersible tablets in pediatric eosinophilic esophagitis
Saverio Pochesci1, Camilo Maza Angulo2, Heather Grant3
1Department of Paediatric Gastroenterology, Hepatology and Nutrition, Royal Hospital for Children & Young People, Edinburgh, UK.
Insights
Budesonide orodispersible tablets (BOT) effectively treated eosinophilic esophagitis (EoE) in children, achieving high rates of clinical and endoscopic remission. Many patients previously unresponsive to other therapies responded well to BOT.
Area of Science:
- Pediatric Gastroenterology
- Allergy and Immunology
- Pharmacology
Background:
- Eosinophilic esophagitis (EoE) is a chronic immune-mediated esophageal disease.
- Current treatments for pediatric EoE include proton-pump inhibitors, dietary changes, and topical swallowed corticosteroids (TSC).
- The effectiveness of budesonide orodispersible tablets (BOT) in pediatric EoE requires further evaluation.
Purpose of the Study:
- To retrospectively evaluate the effectiveness and safety of budesonide orodispersible tablets (BOT) in children diagnosed with eosinophilic esophagitis (EoE).
Main Methods:
- Retrospective evaluation of 17 children with EoE treated with BOT 0.5 mg twice daily.
- Assessment of clinical remission, endoscopic remission, and histological remission after 3 months and longer-term follow-up.
- Comparison of outcomes with previous treatments, including TSC.
Main Results:
- After 3 months, 65% of patients achieved clinical remission.
- Of 8 patients undergoing repeat endoscopy, 75% achieved endoscopic remission and 87.5% achieved histological remission.
- Eosinophil counts significantly decreased (p=0.03), and 75% of patients who failed TSC achieved remission with BOT.
Conclusions:
- Budesonide orodispersible tablets (BOT) demonstrate significant effectiveness in achieving clinical, endoscopic, and histological remission in pediatric eosinophilic esophagitis (EoE).
- BOT is a viable treatment option for pediatric EoE, including for patients refractory to topical swallowed corticosteroids (TSC).
- BOT was well-tolerated with no reported adverse events in this cohort.
Abstract:
We retrospectively evaluated the effectiveness of budesonide orodispersible tablets (BOT) in children with eosinophilic esophagitis (EoE) followed up at our center. A total of 17 children were treated with BOT 0.5 mg twice daily after a median time from diagnosis of 16 months (interquartile range [IQR]: 11-28.5). Previous treatments included proton-pump inhibitors, food elimination diets, and topical swallowed corticosteroids (TSC). After 3 months, 11/17 (65%) patients were in clinical remission. 8/17 (47%) patients repeated an endoscopy after a median time of 11.5 months (6.75-16.75 IQR); 6/8 (75%) were in endoscopic remission and 7/8 (87.5%) achieved histological remission. Eosinophils count at histology significantly decreased from baseline (30 [15-50 IQR] to 6 [6-9 IQR], p = 0.03]. 3/4 (75%) patients who previously failed TSC achieved complete remission on BOT. After a median follow-up of 12.5 months (6.25-21 IQR), 11/17 (65%) patients were still on BOT treatment, and 9/11 (82%) were in clinical remission. No adverse events were reported.
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