Budesonide Oral Suspension for EoE: Advantages and Clinical Efficacy

Budesonide oral suspension was developed to address the practical challenges of delivering topical steroids to the esophagus, particularly in pediatric patients who struggled with metered-dose inhalers. The innovative formulation combines aqueous budesonide with a vehicle agent (originally Splenda) that coats the esophageal surface like a therapeutic lotion, providing sustained anti-inflammatory contact across the entire esophageal expanse. Data from Scintigraphic imaging studies demonstrated that the aqueous form alone fails to adequately coat the esophagus, but the combination vehicle achieves effective coverage. This led to FDA approval of Jorveza (budesonide oral suspension), offering a palatable, portable treatment option that teenagers particularly prefer due to its discreteness and convenience compared with mixing powder packets.

The phase 3 clinical trial represented the largest EoE study conducted in the United States, enrolling patients with significant disease burden averaging 75 eosinophils per high-power field. The study population reflected real-world clinical complexity, with over 80% of participants concurrently using proton pump inhibitors, 18% taking inhaled or nasal corticosteroids, and 10% following dietary restrictions. More than 50% had previously tried other therapies, and approximately 40% had required esophageal dilation, indicating these were treatment-refractory patients rather than easily managed cases.

Clinical efficacy results demonstrated robust histological improvement, with 62.4% of patients achieving the primary end point of 15 or fewer eosinophils per high-power field compared with only 1% with placebo. More stringent responses showed 53.5% reaching 6 or fewer eosinophils and 32.4% achieving deep remission with 1 or fewer eosinophils. Symptom improvement occurred in 52.6% vs 39.1% with placebo, though the notable placebo response reflects the complexity of symptom assessment and potential psychological factors. Importantly, 30% achieved combined histological and symptomatic response compared with 0% with placebo, representing the clinically desired dual improvement in both inflammation and patient-reported outcomes.