Efficacy of Budesonide vs Fluticasone for Initial Treatment of Eosinophilic Esophagitis in a Randomized Controlled Trial

Abstract

Background and aims: Topical steroid treatments for eosinophilic esophagitis (EoE) include swallowed fluticasone from a multi-dose inhaler (MDI) or oral viscous budesonide (OVB) slurry, but the 2 have never been compared. We assessed whether OVB was more effective than MDI for initial treatment of patients with EoE.

Methods: In a double-blind, double-dummy trial, patients with a new diagnosis of EoE were randomly assigned to groups given 8 weeks of either OVB (1 mg/4 mL) twice daily plus a placebo inhaler (n = 56) or fluticasone MDI (880 μg) twice daily plus a placebo slurry (n = 55). Primary outcomes were post-treatment maximum eosinophil counts per high-power field (eos/hpf) and a validated dysphagia score (dysphagia symptom questionnaire [DSQ]) at week 8. Secondary outcomes included endoscopic severity (validated EoE endoscopic reference score), histologic response (<15 eos/hpf), and safety.

Results: In a modified intention-to-treat analysis, the subjects had baseline peak eosinophil counts of 73 and 77 eos/hpf in the OVB and MDI groups, respectively, and DSQ scores of 11 and 8. Post-treatment eosinophil counts were 15 and 21 in the OVB and MDI groups, respectively (P = .31), with 71% and 64% achieving histologic response (P = .38). DSQ scores were 5 and 4 in the OVB and MDI groups (P = .70). Similar trends were noted for post-treatment total EoE endoscopic reference scores (2 vs 3; P = .06). Esophageal candidiasis developed in 12% of patients receiving OVB and 16% receiving MDI; oral thrush was observed in 3% and 2%, respectively.

Conclusions: In a randomized clinical trial, initial treatment of EoE with either OVB or fluticasone MDI produced a significant decrease in esophageal eosinophil counts and improved dysphagia and endoscopic features. However, OVB was not superior to MDI, so either is an acceptable treatment for EoE. ClinicalTrials.gov ID NCT02019758.

Keywords: Comparative-Effectiveness Study; Drugs; Steroids; Therapy.

Figure 1.

CONSORT diagram, with subject flow through the study. The majority of subjects who did not meet the eligibility requirements had proton pump inhibitor-responsive esophageal eosinophilia (PPI-REE; n=46). Of the 16 subjects who were lost to follow-up after randomization and receiving study intervention, 6 did not tolerate the medications due to taste, 8 either no longer wanted to participate due to study logistics or could not be reached, 1 had an adverse event of a food bolus impaction necessitating an ER visit and study withdrawal, and 1 had an environmental allergic reaction requiring a systemic corticosteroids that necessitated study withdrawal.

Figure 2.

Study outcome measures. (A) Primary outcome of peak eosinophil count. (B) Co-primary outcome of the Dysphagia Symptom Questionnaire (DSQ) score. (C) Secondary outcome of histologic response thresholds of <15, <5, and <1 eos/hpf. (D) Secondary outcome of the EoE Endoscopic Reference Score (EREFS).