Budesonide oral suspension (BOS) appears to be a safe and effective induction therapy for eosinophilic esophagitis (EoE) among adolescents and adults, according to results of a phase 3 clinical trial that were presented at the ACG 2019 Annual Scientific Meeting and Postgraduate Course.
To assess the safety and efficacy of BOS among patients aged 11 to 55 years with EoE and dysphagia, Ikuo Hirano, MD, from the Northwestern University Feinberg School of Medicine, and colleagues randomly assigned patients to receive either BOS, 2.0 mg (n=215), or placebo (n=107) twice daily for 12 weeks. Of the 322 participants, 318 received at least 1 dose of double-blind therapy (BOS, n=213; placebo, n=105).
After 12 weeks of therapy, the researchers measured histologic and dysphagia symptom responses. Compared with patients in the placebo group, more patients in the BOS treatment group achieved both of these primary endpoints.
While 1.0% of patients in the placebo group achieved the histologic endpoint, 53.1% of patients in the BOS treatment group achieved the endpoint. While 39.1% of patients in the placebo group achieved the symptoms endpoint, 52.6% of patients in the BOS treatment group achieved the endpoint.
The researchers also evaluated the change in Dysphagia Symptom Questionnaire score from baseline to week 12, as well as the change in EoE Endoscopic Reference Score from baseline to final treatment period. Improvements in both mean scores were significantly greater among patients in the BOS treatment group compared with patients in the placebo group.
The percentage of patients who reported a treatment-emergent adverse event (AE) was the same in both groups (61.0%). Of the patients who experienced an AE, 2.5% discontinued their dosage; 1.4% of patients in the BOS treatment group and 4.8% of patients in the placebo group discontinued
Few patients in either group experienced a severe or serious treatment-emergent AE. None of the patients reported a life-threatening treatment-emergent AE.
“BOS resulted in significant improvements in histologic, symptomatic, and endoscopic endpoints compared with placebo,” Dr Hirano concluded. “The majority of [treatment-emergent AEs] were mild to moderate and comparable between placebo and BOS. A double-blind, placebo-controlled maintenance study (SHP621-302) is ongoing.” —Colleen Murphy