Budesonide orodispersible tablets (BOTs) are highly effective in inducing disease remission in adults with active eosinophilic esophagitis (EOE), according to a study of the tablets versus placebo in European patients.
“A 6-week treatment with 1 mg budesonide twice daily was highly superior over placebo with regard to all predefined primary and secondary outcomes,” wrote Alfredo J. Lucendo, MD, of Hospital General de Tomelloso in Real, Spain, and his coauthors. The study was published in Gastroenterology.
To assess the effectiveness and tolerability of BOT in adults with EOE, Dr. Lucendo and his fellow researchers launched a randomized, placebo-controlled trial made up of 88 European adults with active EoE. Patients were assigned to either a group that received BOT twice daily (n = 59) or a group that received placebo (n = 29). The primary endpoint was complete remission.
After 6 weeks, 34 of 59 patients (58%) receiving BOT had achieved complete remission, compared with 0 patients receiving placebo (P less than .0001). After 12 weeks, 50 of 59 patients (85%) in the BOT group had achieved complete remission. BOT was also well tolerated; no serious adverse event was reported, and no differences were observed between groups with regard to commonly reported adverse events.
The coauthors acknowledged their study’s limitations, including the fact that it was designed to demonstrate budesonide’s superiority to placebo at 6 weeks, not to identify the time of its maximal effect. In addition, the researchers did not identify a minimally effective dose; they did, however, note their belief that a lower dose could still achieve similar rates of remission and “a higher dose would not achieve a higher clinico-remission rate.”
The study was funded by Dr. Falk Pharma. The authors reported numerous conflicts of interest, including receiving research funding and speaker fees from various pharmaceutical companies and foundations.
SOURCE: Lucendo AJ et al. Gastroenterology. 2019 Mar 25. doi: 10.1053/j.gastro.2019.03.025.