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Long-Term Treatment of Eosinophilic Esophagitis With Budesonide Oral Suspension
- Source :
- Clinical Gastroenterology and Hepatology. 20:1488-1498.e11
- Publication Year :
- 2022
- Publisher :
- Elsevier BV, 2022.
-
Abstract
- BACKGROUND & AIMS We evaluated treatment withdrawal, long-term outcomes, and safety of budesonide oral suspension (BOS) 2.0 mg twice daily in patients with eosinophilic esophagitis who completed a 12-week induction study. METHODS Induction full responders (≤6 eosinophils per high-power field [eos/hpf] and ≥30% reduction in the Dysphagia Symptom Questionnaire score) to BOS 2.0 mg twice daily (ORBIT1/SHP621-301/NCT02605837) were randomized to continue BOS (BOS-BOS) or withdraw to placebo (BOS-PBO) for 36 weeks (ORBIT2/SHP621-302/NCT02736409). Induction partial responders and nonresponders, and patients who received induction placebo, received BOS for 36 weeks. The primary end point was the proportion of BOS-BOS and BOS-PBO patients who relapsed (≥15 eos/hpf and ≥4 days of dysphagia [Dysphagia Symptom Questionnaire] over 2 weeks) by week 36. The key secondary end point was the proportion of induction partial responders and nonresponders who fully responded after 52 weeks of total BOS therapy. Other secondary end points included the proportion of induction full responders with histologic responses (≤1, ≤6
- Subjects :
- Budesonide
medicine.medical_specialty
Long term treatment
Anti-Inflammatory Agents
Administration, Oral
Placebo
Gastroenterology
Double-Blind Method
Suspensions
Maintenance therapy
Internal medicine
Eosinophilia
medicine
Clinical endpoint
Humans
Therapy duration
Eosinophilic esophagitis
Hepatology
business.industry
Eosinophilic Esophagitis
medicine.disease
Dysphagia
Enteritis
humanities
Treatment Outcome
Gastritis
medicine.symptom
Deglutition Disorders
business
medicine.drug
Subjects
Details
- ISSN :
- 15423565
- Volume :
- 20
- Database :
- OpenAIRE
- Journal :
- Clinical Gastroenterology and Hepatology
- Accession number :
- edsair.doi.dedup.....17be584a5371cc19728489d23c55149e