SAN DIEGO — Patients receiving budesonide orodispersible tablets for the treatment of eosinophilic esophagitis were able to maintain remission through 48 weeks, according to study results presented at Digestive Disease Week.
Alfredo Lucendo, MD, of the department of gastroenterology at Hospital General de Tomelloso in Spain, said previous studies have shown that budesonide orodispersible tablets (BOT) induce remission in patients with EoE.
“This maintenance of remission trial had the primary goal to assess the efficacy of two doses of this novel formulation of budesonide compared to placebo to maintain adult patients with EoE into remission in the long-term,” he said in his presentation. “We also wanted to study tolerability in the form of adverse events of this drug and to check the changes in quality of life.”
For their study, researchers recruited 204 patients with EoE who either achieved induction of remission at the end of the EOS-1 trial or after a 6-week open-label induction of BOT 1 mg twice a day. Then, they randomly assigned patients to receive either 1 mg (n = 68) or 0.5 mg (n = 68) BOT twice a day or placebo (n = 68).
After 48 weeks, Lucendo and colleagues found that 51 patients in the 1 mg group (75%) and 50 patients in the 0.5 mg group (73.5%) were free of treatment failure compared with just three in the placebo group (4.4%; both P < .0001). Fewer patients in the BOT groups experienced histological relapse and clinical relapse compared with patients in the placebo group (all P < .0001). Both the 1 mg and 0.5 mg BOT groups had a higher percentage of patients in clinical remission at week 48 (73.5% and 72.1%, respectively) compared with the placebo group (20.6%; both P < .0001).
Investigators found that BOT was also safe and well-tolerated among patients.
“Most patients receiving this medication were able to maintain a deep histological and deep endoscopic remission ... supporting the superiority of this novel formulation to provide optimal esophageal targeting of the esophageal mucosa,” Lucendo concluded. – by Alex Young
Lucendo A, et al. Abstract 951a. Presented at: Digestive Disease Week; May 18-21, 2019; San Diego.
Disclosures: Lucendo reports receiving investigator’s fees from Dr. Falk Pharma. Please see the meeting disclosure index for all other authors’ relevant financial disclosures.