Treatment with budesonide oral suspension resulted in improvements in symptomatic, endoscopic, and histologic parameters among adolescent and young adult patients with eosinophilic esophagitis (EoE), according to a study published in Gastroenterology.
Evan S. Dellon, MD, MPH, from the University of North Carolina, and colleagues conducted a randomized, controlled phase 2 trial to assess the ability of budesonide oral suspension, a muco-adherent topical steroid formulation, to reduce the symptoms and esophageal eosinophilia in EoE.
The researchers randomly assigned 93 EoE patients between 11 and 40 years of age to receive either budesonide oral suspension 2 mg or placebo twice daily for 12 weeks. Primary outcomes were the change in Dysphagia Symptom Questionnaire (DSQ) score from baseline and the proportion of patients with a histologic response after treatment (≤6 eosinophils/high-power field).
The mean DSQ scores at the start of the study were 29.3 in the budesonide oral suspension group and 29.0 in the placebo group, and the mean peak eosinophil counts were 156 per high-power field (hpf) in the budesonide oral suspension group and 130 per hpf in the placebo group.
After treatment, the DSQ scores were 15.0 in the budesonide oral suspension group and 21.5 in the placebo group, and the mean peak eosinophil counts were 39 per hpf in the budesonide oral suspension group and 113 hpf in the placebo group.
Overall, the change in DSQ score for budesonide oral suspension compared with placebo was -14.3 vs -7.5. In addition, the histologic response rates were 39% vs 3%, and the change in endoscopic severity score was -3.8 vs 0.4. The researchers noted that adverse events were similar in both groups.
“There were no unexpected safety signals, and compliance with medication was high, suggesting that this formulation can be reliably used,” the study authors wrote. “In addition, this is the first prospective study to use a validated [patient reported outcome] instrument and a validated endoscopy classification to demonstrate improvement in dysphagia symptoms and endoscopic severity scores. [Budesonide oral suspension] is therefore a promising formulation for treatment of EoE.”
- Dellon ES, Katzka DA, Collins MH, et al. Budesonide oral suspension improves symptomatic, endoscopic, and histologic parameters compared with placebo in patients with eosinophilic esophagitis. Gastroenterology. 2017;152:776-786. doi:10.1053/j.gastro.2016.11.021