Efficacy and Safety of Long-Term Treatment With Budesonide Orodispersible Tablets in Patients With Eosinophilic Esophagitis.

INTRODUCTION: Budesonide orodispersible tablets (BOT) has improved eosinophilic esophagitis (EoE) outcomes. This study aimed to evaluate in real-life the efficacy of BOT and adverse events in induction and maintenance therapy.

METHODS: Patients with EoE receiving BOT (2 mg/day induction, 1 mg/day maintenance) were retrospectively analyzed over a 1-year follow-up. Clinical (Straumann Dysphagia Index [SDI]), endoscopic (Endoscopic Reference Score [EREFS]), and histological (eosinophils <15/HPF) responses were assessed at 12 weeks (T1) and 52 weeks (T2).

RESULTS: Among 104 patients enrolled, at T1 97.8% of patients achieved histologic remission and 70.3% maintained remission at T2 with a significant improvement of EREFS and SDI. Higher SDI during induction (odds ratio [OR]: 0.72; 95% CI: 0.56-0.93) and maintenance (OR: 0.65; 95% CI: 0.52-0.82) predicted loss of histologic remission at T2. BOT-proton pump inhibitor (PPI) coadministration during maintenance therapy increased the probability for histological response at T2 (OR: 7.8; 95% CI: 2.4-25.4). After induction, significant increase in incidence of erosive esophagitis was observed (2.2% vs 13.0%, P = 0.013), with BOT-PPI coadministration being protective toward it (OR: 0.14; 95% CI: 0.03-0.54). Local candidiasis was the most common adverse events at T1 and T2. Risk factors of candidiasis included a history of gastroesophageal reflux disease (OR: 3.71; 95% CI: 1.14-12.09), EoE family history (OR: 16.94; 95% CI: 1.78-161.4), oral allergy syndrome (OR: 3.53; 95% CI: 1.29-9.66).

DISCUSSION: BOT is effective and overall safe in inducing and maintaining EoE remission. Erosive esophagitis incidence is higher during BOT therapy, supporting BOT-PPI combination in select cases. Clinical monitoring with SDI may help guide maintenance therapy and follow-up timing.