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Maintenance therapy with once or twice daily budesonide orodispersible tablets after budesonide viscous solution in eosinophilic esophagitis
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DOI:10.1177/17562848261465758.png)
Abstract
En 中文
<jats:sec>
<jats:title>Background:</jats:title>
<jats:p>Budesonide orodispersible tablets (BOT) are the first drug specifically developed for eosinophilic esophagitis (EoE), whereas budesonide viscous solution (BVS) is used off-label.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Objectives:</jats:title>
<jats:p>We aimed to assess the histological, endoscopic, clinical, and safety outcomes before and after switching maintenance therapy from BVS to BOT.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Design:</jats:title>
<jats:p>Observational cohort study of EoE patients who switched therapy from BVS to BOT at the same dose (1 mg) and dosing schedule (once daily (OD) or twice daily (BID)).</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Methods:</jats:title>
<jats:p>We performed a retrospective analysis of a prospectively collected dataset. Routine procedures included endoscopy with biopsies to assess histological and endoscopic disease and whether candidiasis was present. Histological remission was defined as <15 eosinophils per high-power field (eos/HPF) and deep histological remission as <6 eos/HPF. Online questionnaires, including dysphagia symptom questionnaire (DSQ), eosinophilic esophagitis symptom activity index (EEsAI), numerical rating scale (NRS) for symptoms and adult eosinophilic esophagitis quality of life questionnaire (EoE-QoL-A), were filled out by patients to assess symptom severity and health-related quality of life (HRQoL). Data are presented as proportions or medians with interquartile ranges, using non-parametric paired tests for proportions or other variables.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Results:</jats:title>
<jats:p>
In total, 45 patients were included. The majority of patients switched to BOT 1 mg OD (
<jats:italic toggle="yes">n</jats:italic>
= 32, 25 males, age 35 (27.8–40.3) years and body mass index 24.3 (21.4–27.5) kg/m²). Endoscopy and questionnaires were repeated 170 (145.3–182) days after switch. The proportion of patients achieving histological (
<jats:italic toggle="yes">p</jats:italic>
= 0.04) and deep histological (
<jats:italic toggle="yes">p</jats:italic>
= 0.01) remission increased significantly. The total endoscopic reference score decreased significantly (
<jats:italic toggle="yes">p</jats:italic>
= 0.003). Symptoms remained low (DSQ:
<jats:italic toggle="yes">p</jats:italic>
= 1; EEsAI:
<jats:italic toggle="yes">p</jats:italic>
= 0.9; NRS:
<jats:italic toggle="yes">p</jats:italic>
= 0.1), while a significant improvement in HRQoL (EoE-QoL-A:
<jats:italic toggle="yes">p</jats:italic>
= 0.008) was observed. A numeric increase in candidiasis was noted (
<jats:italic toggle="yes">p</jats:italic>
= 0.3). Similar results were obtained for EoE patients switching maintenance therapy from BVS to BOT 1 mg BID.
</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Conclusion:</jats:title>
<jats:p>Maintenance therapy with BOT after BVS may be feasible and effective in the real-world management of EoE patients, with only a numeric increase in the endoscopic suspicion of candidiasis.</jats:p>
</jats:sec>
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