Novel Oral Budesonide Prep Treats Eosinophilic Esophagitis
Phase 2 study shows significant improvements in symptomatic, endoscopic, histologic parameters
TUESDAY, March 28, 2017 (HealthDay News) -- Budesonide oral suspension (BOS) is associated with improvement in symptomatic, endoscopic, and histologic parameters in adolescent and young adult patients with eosinophilic esophagitis (EoE), according to a study published in the March issue of Gastroenterology.
Evan S. Dellon, M.D., M.P.H., from the University of North Carolina at Chapel Hill, and colleagues conducted a trial involving 93 EoE patients aged 11 to 40 years with dysphagia and active esophageal eosinophilia who were randomly allocated to receive BOS or placebo twice daily.
The mean Dysphagia Symptom Questionnaire (DSQ) scores were 29.3 and 29.0 at baseline in the BOS and placebo groups, respectively, and mean peak eosinophil counts were 156 and 130 per high-power field (hpf), respectively. The researchers found that DSQ scores were 15.0 and 21.5 in the BOS and placebo groups, respectively, after treatment, and the corresponding mean peak eosinophil counts were 39 and 113 per hpf (all P < 0.05). For BOS versus placebo there were significant changes in DSQ score (−14.3 versus −7.5; P = 0.0096), histologic response rates (39 versus 3 percent; P < 0.0001), and endoscopic severity score (−3.8 versus 0.4; P < 0.0001). Similar adverse events were seen between the groups.
"Treatment with BOS was well tolerated in adolescent and young adult patients with EoE and resulted in improvement in symptomatic, endoscopic, and histologic parameters using validated outcome instruments," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Meritage Pharma, which funded the study.