Budesonide oral suspension shows potential in patients with eosinophilic esophagitis
Patients with eosinophilic esophagitis (EoE) treated with budesonide oral suspension (TAK-721; Takeda Pharmaceuticals) had an improvement in endoscopic and histologic response, according to data from the post hoc analyses from a Phase 3 clinical trial presented at the American College of Gastroenterology Annual Scientific Meeting 2020.
Patients (ages 11 to 55 years) treated with BOS had significantly greater improvements in total endoscopic reference score (EREFS) from baseline to week 12 of therapy compared with patients receiving placebo. A post-treatment total EREFS of 4 was determined to be the optimal threshold for distinguishing a histological response to treatment with BOS.
Data from a second presentation, which found patients treated with BOS had greater improvements in peak eosinophil counts and eosinophilic esophagitis histology scoring system (EoEHSS) grade and stage total score ratios compared with patients treated with placebo after 12 weeks, emphasized the importance of EoEHSS in monitoring disease activity in patients with EoE.
Hirano I, et al. Determination of the eosinophilic esophagitis endoscopic reference score associated with histologic response to therapy: Analysis from a phase 3 placebo-controlled trial of budesonide oral suspension. Presented at: American College of Gastroenterology Annual Scientific Meeting 2020. P0909 (S0435)
Collins MH, et al. Improved histopathologic features in patients with eosinophilice esophagitis: Results and analyses from a Phase 3, randomized, placebo-controlled trial of budesonide oral suspension. Presented at: American College of Gastroenterology Annual Scientific Meeting 2020. P0878 (S0404)