EoE Module 10 References-Lucendo et al Gastroenterol 2019 Efficacy of budesonide orodispersible tablets as induction therapy for EoE in a RCT

Lucendo et al Gastroenterol 2019 Efficacy of budesonide orodispersible tablets as induction therapy for EoE in a RCT

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This study evaluates the effectiveness of budesonide orodispersible tablets (BOT) as an induction therapy for adults with active eosinophilic esophagitis (EoE), a chronic disease characterized by esophageal dysfunction and inflammation. Conducted as a randomized, placebo-controlled trial involving 88 adults across Europe, the study aimed to assess BOT's efficacy in achieving clinical and histological remission of EoE.<br /><br />Participants were divided into two groups, receiving BOT (1 mg twice daily) or a placebo for six weeks. Key outcomes focused on achieving complete remission, defined by dysphagia and odynophagia severity scores and a peak eosinophil count meeting specified criteria. For those who did not attain remission after six weeks with placebo, an additional six-week open-label BOT treatment was offered.<br /><br />Results demonstrated that 58% of BOT-treated patients achieved complete remission at six weeks, compared to none in the placebo group. Histological remission rates were 93% for BOT versus 0% in the placebo group. After twelve weeks, BOT treatment led to remission in 85% of the participants. BOT was well-tolerated, with minor side effects, including mild symptomatic candidiasis occurring in 5% of BOT recipients, treatable with oral antifungal medication.<br /><br />The study concludes that BOT is significantly more effective than placebo in inducing remission in EoE patients, validating its development as a specialized treatment for this condition. However, long-term effects, maintenance strategies, and dosing remain to be explored further. Despite selection bias towards PPI-resistant patients, the findings establish BOT as a promising licensed therapy for EoE, likely to benefit a majority of patients with appropriate symptom and inflammation control.

Keywords

budesonide orodispersible tablets

eosinophilic esophagitis

induction therapy

randomized placebo-controlled trial

clinical remission

histological remission

dysphagia

odynophagia

candidiasis

treatment efficacy