Maintenance therapy with once or twice daily budesonide orodispersible tablets after budesonide viscous solution in eosinophilic esophagitis.

BACKGROUND

Budesonide orodispersible tablets (BOT) are the first drug specifically developed for eosinophilic esophagitis (EoE), whereas budesonide viscous solution (BVS) is used off-label.

OBJECTIVES

We aimed to assess the histological, endoscopic, clinical, and safety outcomes before and after switching maintenance therapy from BVS to BOT.

DESIGN

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)).

METHODS

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.

RESULTS

In total, 45 patients were included. The majority of patients switched to BOT 1 mg OD (n = 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 (p = 0.04) and deep histological (p = 0.01) remission increased significantly. The total endoscopic reference score decreased significantly (p = 0.003). Symptoms remained low (DSQ: p = 1; EEsAI: p = 0.9; NRS: p = 0.1), while a significant improvement in HRQoL (EoE-QoL-A: p = 0.008) was observed. A numeric increase in candidiasis was noted (p = 0.3). Similar results were obtained for EoE patients switching maintenance therapy from BVS to BOT 1 mg BID.

CONCLUSION

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.