Introduction 

This study, published in Clinical Gastroenterology and Hepatology Journal, examines the efficacy of fluticasone oral disintegrating propionate tablets in treating eosinophilic esophagitis (EoE), a chronic inflammatory condition of the oesophagus.

EoE poses significant challenges for patients due to symptoms like difficulty swallowing (dysphagia) and oesophageal tissue inflammation. Understanding the effectiveness of treatment options is crucial for improving patient outcomes and quality of life.

Oral budesonide oral dispersible tablet (Jorveza) is an approved treatment for adults in Europe, Canada and Australia. In the USA and EU there has been recent approval of a biological treatment (Dupilumab) for age 12+ however, unlike Europe, this is currently the only FDA-approved treatment meaning ongoing use off label oral topical steroids (budesonide and fluticasone) and PPIs for children and those unable to access the biological treatment.

This randomised phase 2 controlled trial provides valuable insights into the impact of fluticasone propionate tablet on histologic response rates and dysphagia frequency in EoE patients. By exploring the findings of this study, we gain a deeper understanding of the potential benefits of this treatment approach, and how to minimise the negative impact of side effects thus contributing to the advancement of EoE management strategies and ultimately improving patient care.

Background and Objectives

Topical steroids are effective treatments for eosinophilic esophagitis (EoE). The FLUTE (Fluticasone in EoE) trial evaluated the safety and efficacy of APT-1011 (fluticasone propionate oral disintegrating tablet) vs placebo for treatment of EoE.

Methods

In this phase 2b, double-blind, placebo-controlled, randomised trial, 106 adult EoE patients received either one of four doses of APT-1011 or a placebo over a 12-week induction period, followed by a 40-week maintenance period. The primary outcome targeted was a histologic response (≤6 eosinophils per high-power field) at Week 12, while secondary outcomes included assessing endoscopic features and the frequency of dysphagia (difficulty in swallowing).

Findings

The results revealed significant histologic response rates among the groups receiving APT-1011 compared to the placebo group.

Specifically, response rates were 80% for the APT-1011 3 mg twice daily (BID) dose, 67% for 3 mg at bedtime (HS), 86% for 1.5 mg BID, and 48% for 1.5 mg HS, compared to 0% for the placebo group (P < .001 for all groups vs placebo).

At Week 12, a notable improvement was observed in the Oedema/Rings/Exudates/Furrows/Strictures (EoE Endoscopic Reference Score) total score for all APT-1011 dosage groups compared to the placebo group. 

Furthermore, all active groups demonstrated a significant reduction in the mean frequency of dysphagia over 14 days, and these improvements persisted to Week 52.

Safety Assessment 

APT-1011 was deemed safe and well-tolerated. Researchers observed a higher incidence (50%) of candidiasis (a fungal infection) at the higher twice-daily doses.

Conclusion 

The study concludes APT-1011 dosing regimens proved superior in inducing histologic and endoscopic responses and reducing dysphagia frequency compared to the placebo. Considering symptom improvement, adverse event assessment, and the histologic response rate, the 3 mg once daily at bedtime dose demonstrated and fewer side effects were considered the most favourable risk-benefit for this chronic disease treatment.

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