Budesonide therapy safe, efficacious in the treatment of EoE
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In patients with eosinophilic esophagitis, budesonide oral suspension improved histologic, symptomatic and endoscopic outcomes, according to research published in Clinical Gastroenterology and Hepatology.
“Currently, no pharmacologic therapies are approved by the FDA for EoE. As a result, patients often resort to using off-label corticosteroids formulated for asthma leading to suboptimal esophageal delivery and experience difficulties with medical insurance coverage owing to the off-label utilization,” Ikuo Hirano, MD, division of gastroenterology and hepatology at Northwestern University Feinberg School of Medicine, and colleagues wrote. “Budesonide oral suspension (BOS) is an immediate-release topical corticosteroid optimized as a viscous suspension to lengthen its residence time on the esophageal mucosal surface following oral administration in patients with EoE.”
In a double-blind, placebo-controlled, phase 3 trial, researchers evaluated the safety and efficacy of BOS therapy in 318 patients (aged 11- 55 years) with EoE and dysphagia. Researchers randomly assigned patients 2:1 to receive BOS 2 mg twice daily (n = 213) or placebo (n = 105) for 12-weeks. Analyzed endpoints included the proportion of stringent histologic or dysphagia symptom responders as well as changes in Dysphagia Symptom Questionnaire (DSQ) score and EoE Endoscopic Reference Score (EREFS).
Compared with patients treated with placebo, patients treated with BOS achieved greater stringent histologic response (53.1% vs. 1%; 95% CI, 43.3%-59.1%) or dysphagia symptom response (52.6% vs. 39.1%; 95% CI, 1.6%-24.3%) after 12-weeks; patients treated with BOS also achieved a greater stringent histologic response in addition to dysphagia symptom response (30% vs. 0%; 95% CI, 23.7%-36%). Further results report patients treated with BOS had greater improvement in DSQ scores (–13 vs. –9.1; 95% CI, –7.1 to –0.8) and EREFS (–4 vs. –2.2; 95% CI, –2.1 to –1.1).
“This phase 3 trial demonstrated that patients receiving BOS 2 mg for 12 weeks had superior improvements in histologic, symptomatic and endoscopic outcomes compared with those receiving placebo. The co-primary and key secondary efficacy endpoints were met, and BOS was well tolerated,” Hirano and colleagues concluded. “This study addresses the existing unmet medical need of patients with EoE in the United States.”
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