Effectiveness and Safety of Orodispersible Budesonide for Eosinophilic Esophagitis: A Multicenter Real-World Study.

Background & aims: Topical corticosteroids represent one of the effective first-line treatment options for eosinophilic esophagitis (EoE), and therapy with budesonide orodispersible tablets (BOTs) has been recently approved for the treatment of EoE and showed great efficacy in randomized-controlled clinical trials, however real-life data are lacking. Thus, we aimed to evaluate the effectiveness of treatment with BOTs in adult EoE patients in a real-life setting.

Methods: In this prospective study, clinical, histologic, endoscopic, and safety measures were assessed. Patients underwent evaluation after the induction period (12 weeks) and up 1 year of treatment with BOTs. Dysphagia Symptom Questionnaires were used for symptoms; the Adult Eosinophilic Esophagitis Quality of Life questionnaire for quality of life; the Endoscopic Reference Score for endoscopic activity; eosinophilic peaks (eosinophils per high-power field) for histologic activity.

Results: A total of 233 patients were enrolled and 203 completed the assessments after 12 weeks. Deep histological remission was achieved by 84% of patients, as well as clinical remission, associated with an improvement in quality of life. Eighty-six patients concluded 1 year of treatment, and 78% were still in deep remission, while 15% experienced a loss of histological response at treatment tapering. Primary nonresponders were 8%, and secondary nonresponders were 3%. No serious adverse effects were recorded. Only mild side effects related to drug assumption were reported by 28 (12%) of 233 patients, and the most common were oral symptoms.

Conclusions: Our real-world data confirm that BOTs are effective in inducing clinical and histologic remission in most EoE patients. The drug has a good safety profile, with side effects occurring only in a small number of patients.