P=0.024).
Budesonide oral suspension (BOS) was also well tolerated, and most adverse events were mild to moderate in severity, the researchers noted.
The double-blind phase III ORBIT1/SHP621301 trial, conducted at 66 centers in the U.S. from 2015 to 2019, evaluated the efficacy and safety of BOS in patients ages 11 to 55 with EoE-related dysphagia. The mean age of patients in both arms was just under 34, and about 60% in both arms were male. More than 90% in both groups were white, and body mass index was elevated in each, at 27.5 and 28.2, respectively.
Overall, 318 patients were randomized (213 to BOS and 105 to placebo), and received at least one dose of study treatment.