Oral budesonide suspension improved dysphagia symptoms, histology in EoE

WASHINGTON — Oral budesonide suspension safely improved symptoms of dysphagia and esophageal eosinophilia in adolescent and adult patients with active eosinophilic esophagitis, according to data presented at Digestive Disease Week.

“Topical corticosteroids are the first-line pharmacologic treatment for EoE,” Evan S. Dellon, MD, MPH, from the University of North Carolina School of Medicine at Chapel Hill, said in his presentation. These medications “are swallowed rather than inhaled, and there are two main formulations: a multidose inhaler, such as fluticasone, and a liquid slurry, such as oral viscous budesonide. While their use is supported by observational and randomized controlled trial data, none are approved by the FDA for treatment of EoE, and none have been assessed with a validated patient reported outcome measure. Oral budesonide suspension is a novel muco-adherent topical steroid formulation that was developed specifically for use in EoE.”

Evan S. Dellon

Aiming to assess the safety and efficacy of oral budesonide suspension compared with placebo for decreasing symptoms of dysphagia and esophageal eosinophil counts in adolescents and adults with EoE, Dellon and colleagues performed a double-blinded randomized controlled trial from July 2012 to May 2014 involving 87 EoE patients (aged 11-40 years; mean age, 26 years; 70% male; 95% white) from 25 centers.

Patients with peak of 15 eosinophils per high-power field (eos/hpf) or higher from two or more esophageal levels on screening endoscopy and 4 or more days with symptoms of dysphagia over 2 weeks during a 4-week blinded run-in period were randomly assigned to receive twice daily 2 mg oral budesonide suspension or placebo for 12 weeks. Patients completed the Dysphagia Symptom Questionnaire (DSQ) daily during the treatment period and underwent follow-up endoscopy with biopsy at week 12. The primary outcomes were change in DSQ score and the proportion of patients with histologic response defined as 6 eos/hpf or less.

Baseline mean peak eosinophil counts were 156 eos/hpf for the treatment group and 130 eos/hpf for the placebo group, and the mean DSQ scores were 29.3 (range 8-50) and 29.0 (range 7-60), respectively. After treatment mean peak eosinophil counts decreased by 65% to 39 eos/hpf for the treatment group and by 10% to 113 eos/hpf for the placebo group, while DSQ scores dropped to 15.0 and 21.5, respectively (all P < 0.05). Change in DSQ scores were –14.3 for the treatment group compared with –7.5 for the placebo group (P = 0.0096) and the histologic response rates were 39% and 3%, respectively (P < 0.0001). Adverse events between groups were comparable.

“In summary [oral budesonide suspension] was superior to placebo for decreasing symptoms of dysphagia and decreasing esophageal eosinophilia and inducing histologic response,” Dellon concluded. “Additionally, there were no safety issues related to [oral budesonide suspension] that were identified during the 12-week treatment period.” – by Adam Leitenberger

For more information:

Dellon ES, et al. Abstract 813. Presented at: Digestive Disease Week, May 16-19, 2015; Washington, D.C.

Disclosure: Dellon reports various financial relationships with Aptalis, Diagnovus, Meritage Pharmaceuticals, Novartis, Receptos and Regeneron. Please see the DDW faculty disclosure index for all other researchers’ relevant financial disclosures.