EoE Module 10 References-Dellon ES et al Clin Gastroenterol Hepatol 2022 Fluticasone Propionate Orally Disintegrating Tablet (APT-1011) for EoE RCT

Dellon ES et al Clin Gastroenterol Hepatol 2022 Fluticasone Propionate Orally Disintegrating Tablet (APT-1011) for EoE RCT

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The FLUTE trial investigated the safety and efficacy of APT-1011, a fluticasone propionate orally disintegrating tablet, as a treatment for eosinophilic esophagitis (EoE). Conducted as a randomized, double-blind, placebo-controlled trial, it included 106 adults with EoE who received various doses of APT-1011 or a placebo over 12 weeks. Primary outcomes were measured by histologic response, requiring less than 6 eosinophils per high-power field by week 12, as well as improvements in endoscopic features and dysphagia frequency. <br /><br />Results demonstrated significant histologic response rates for all active treatment groups compared to 0% for placebo, with the highest rate of 86% for the 1.5 mg BID dose. The 3 mg HS dose exhibited a well-balanced efficacy and safety profile and was recommended for further study in phase 3 trials. Improvements in endoscopic severity and dysphagia were also sustained through week 52 of treatment. However, higher doses, particularly the 3 mg BID, showed a higher incidence of candidiasis, indicating the need for careful consideration of dosing.<br /><br />The study concluded that APT-1011 is effective for both short- and long-term management of EoE, with favorable histologic and symptomatic responses. With further clinical development, APT-1011 could offer a targeted treatment with minimal systemic exposure, potentially improving patient adherence with once-daily dosing. The trial was registered under ClinicalTrials.gov number NCT03191864. This study adds to the understanding of EoE treatment, potentially addressing unmet needs with its promising safety and efficacy profile.

Keywords

FLUTE trial

APT-1011

fluticasone propionate

eosinophilic esophagitis

randomized trial

histologic response

endoscopic features

dysphagia

candidiasis

ClinicalTrials.gov NCT03191864