Eosinophilic esophagitis (EoE) activity rapidly recurred after initial response to oral viscous budesonide (OVB) or fluticasone from a multidose inhaler (MDI), indicating the need for maintenance therapy for patients who achieve histologic response to topical steroids, according to a study published in Clinical Gastroenterology and Hepatology.  

EoE is chronic and appears to recur with cessation of treatment. This randomized, double-blind, double-dummy trial compared OVB to MDI for initial EoE treatment. Participants showing histologic response (<15 eosinophils/high-power field [eos/hpf]) during the randomized phase of the trial entered an observation phase, during which treatment was discontinued and symptoms were monitored. When symptoms recurred or at 1-year follow-up, participants underwent biopsy or endoscopy. Time to symptom recurrence was analyzed, and endoscopic severity according to EoE Endoscopic Reference Score and histologic relapse (≥15 eos/hpf) were assessed.

Fifty-seven percent of the 58 participants (n=33) experienced symptom recurrence before 1 year, with a median time to recurrence of 244 days. No significant difference in rate of symptom recurrence was seen between OVB participants (263 days) and MDI participants (224 days; P =.91) (hazard ratio 1.04; 95% CI, 0.52-2.08). Of the participants who underwent endoscopy and had complete outcome assessments, the Dysphagia Symptom Questionnaire score more than doubled compared to start of observation phase (3.8 vs 8.7; P <.001), and participants also showed significant increases in mean EoE Endoscopic Reference Score (1.3 vs 4.6; P <.001). Overall, 78% of participants experienced histological relapse, and 94% showed some degree of eosinophilic infiltration on biopsy (≥1 eos/hpf).


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Although the study was limited by a small sample size taken from a single referral center, study investigators conclude that these findings “justify the use of maintenance therapy in patients with EoE who achieve disease remission on topical/swallowed steroids.  The optimal long-term dose of topical steroids, potential for adverse events, and need for safety data remain areas that require future study.”

Disclosure: One study author declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Dellon ES, Woosley JT, Arrington A, et al. Rapid recurrence of eosinophilic esophagitis activity after successful treatment in the observation phase of a randomized, double-blind, double-dummy trial [published online September 6, 2019]. Clin Gastroenterol Hepatol. doi: 10.1016/j.cgh.2019.08.050