Rapid recurrence of eosinophilic esophagitis activity after successful treatment in the observation phase of a randomized, double-blind, double-dummy trial

ES Dellon, JT Woosley, A Arrington, SJ McGee… - Clinical …, 2020 - Elsevier
ES Dellon, JT Woosley, A Arrington, SJ McGee, J Covington, SE Moist, JH Gebhart…
Clinical Gastroenterology and Hepatology, 2020Elsevier
Background & Aims Eosinophilic esophagitis (EoE) is chronic and recurs if treatment is
discontinued. We aimed to determine rates of recurrence, and whether initial treatment with
oral viscous budesonide (OVB) resulted in less recurrence than fluticasone from a multidose
inhaler (MDI). Methods This was the observation phase of a randomized, double-blind,
double-dummy trial comparing OVB with MDI for initial EoE treatment. Subjects with a
histologic response (< 15 eosinophils/high-power field) in the trial entered an observation …
Background & Aims
Eosinophilic esophagitis (EoE) is chronic and recurs if treatment is discontinued. We aimed to determine rates of recurrence, and whether initial treatment with oral viscous budesonide (OVB) resulted in less recurrence than fluticasone from a multidose inhaler (MDI).
Methods
This was the observation phase of a randomized, double-blind, double-dummy trial comparing OVB with MDI for initial EoE treatment. Subjects with a histologic response (<15 eosinophils/high-power field) in the trial entered an observation phase in which treatment was discontinued and symptoms were monitored. Patients underwent an endoscopy or a biopsy when symptoms recurred or at 1 year. We analyzed time to symptom recurrence and assessed endoscopic severity and histologic relapse (≥15 eosinophils/high-power field) at follow-up endoscopy.
Results
Thirty-three of the 58 subjects (57%) had symptom recurrence before 1 year. The overall median time to symptom recurrence was 244 days. There was no difference in the rate of symptom recurrence for subjects treated with OVB vs MDI (hazard ratio, 1.04; 95% CI, 0.52–2.08). At symptom recurrence, 78% of patients had histologic relapse. The patients had significant increases in mean Dysphagia Symptom Questionnaire score (3.8 vs 8.7; P < .001), and the EoE Endoscopic Reference Score (1.3 vs 4.6; P < .001) compared with end of treatment.
Conclusions
EoE disease activity recurred rapidly after initial histologic response to topical steroids (either OVB or MDI). Because most subjects had recurrent endoscopic and histologic signs not reliably detected by symptoms, maintenance therapy should be recommended in EoE patients achieving histologic response to topical steroids. Clinicaltrials.gov no: NCT02019758.
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