Efficacy and safety of long-term treatment with budesonide orodispersible tablets in patients with Eosinophilic Esophagitis

Introduction and aims: Orodispersible budesonide tablets (BOT) has improved eosinophilic esophagitis (EoE) outcomes. This study aims to evaluate in real-life the efficacy of BOT and adverse events in induction and maintenance therapy. Methods: EoE patients receiving BOT (2 mg/day induction, 1 mg/day maintenance) were retrospectively analyzed over a 1-year follow-up. Clinical (SDI), endoscopic (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 (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-PPI co-administration 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 (EE) was observed (2.2% vs 13.0%, p=0.013), with BOT-PPI co-administration being protective towards it (OR: 0.14; 95%CI:0.03-0.54). Local candidiasis was the most common AE at T1 and T2. Risk factors for candidiasis included a history of GERD (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). Conclusion: BOT is effective and overall safe in inducing and maintaining EoE remission. EE 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.