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. 2025 Sep 8:S1542-3565(25)00753-0.
doi: 10.1016/j.cgh.2025.08.033. Online ahead of print.

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

Daria Maniero  1 , Matteo Ghisa  2 , Alessandro Bruschi  3 , Greta Lorenzon  1 , Luisa Bertin  1 , Giorgia Giorgini  4 , Emanuele Bendia  4 , Marina Coletta  5 , Roberto Penagini  5 , Pierfrancesco Visaggi  6 , Nicola de Bortoli  6 , Edoardo Vespa  7 , Alberto Barchi  7 , Amir Mari  8 , Emanuele Dilaghi  9 , Bruno Annibale  9 , Paola Iovino  10 , Elvira Di Feo  10 , Marco Caminati  11 , Federico Caldart  12 , Salvatore Russo  13 , Elisa Marabotto  14 , Andrea Pasta  15 , Rosa Lovero  16 , Antonio Pisani  16 , Antonio Di Sabatino  17 , Marco Vincenzo Lenti  17 , Carlo Maria Rossi  17 , Stefania Merli  17 , Davide Giuseppe Ribaldone  18 , Erica Bonazzi  1 , Edoardo Vincenzo Savarino  19
Affiliations
Free article

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

Daria Maniero et al. Clin Gastroenterol Hepatol. .
Free article

Abstract

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.

Keywords: Eosinophilic Esophagitis; Inflammation; Steroids; Therapy; Type 2 Inflammation.

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