Background and aims: Topical corticosteroids represent one of the effective first-line treatment options for 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 is 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 one year of treatment with BOTs. DSQs were used for symptoms; EoE-QoL-A for QoL; EREFS for endoscopic activity; eosinophilic peaks (eos/hpf) 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 QoL. 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 non-responders were 8%, and secondary non-responders were 3%. No serious adverse effects were recorded. Only mild side effects related to drug assumption were reported by 28/233 patients (12%), and the most common were oral symptoms. Conclusion: 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.
Effectiveness and Safety of Orodispersible Budesonide for Eosinophilic Esophagitis: A Multicenter Real-World Study
Visaggi, Pierfrancesco;de Bortoli, Nicola;
2025-01-01
Abstract
Background and aims: Topical corticosteroids represent one of the effective first-line treatment options for 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 is 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 one year of treatment with BOTs. DSQs were used for symptoms; EoE-QoL-A for QoL; EREFS for endoscopic activity; eosinophilic peaks (eos/hpf) 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 QoL. 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 non-responders were 8%, and secondary non-responders were 3%. No serious adverse effects were recorded. Only mild side effects related to drug assumption were reported by 28/233 patients (12%), and the most common were oral symptoms. Conclusion: 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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
