Budesonide orodispersible tablets safely maintain remission in EoE
Budesonide orodispersible tablets (BOTs) can effectively maintain remission in patients with eosinophilic oesophagitis (EoE), reports a recent phase III, randomized, placebo-controlled trial.
A total of 204 adult EoE patients participated in the study. Sixty-eight patients each were randomized to receive 0.5-mg or 1.0-mg BOT twice daily, or a corresponding placebo. Treatment lasted for 48 weeks, after which the primary outcome of remission was assessed according to the absence of the following criteria: clinical or histological relapse, food impaction needing endoscopic intervention, need for dilation, or premature withdrawal.
At end of treatment, 73.5 percent and 75.0 percent of the patients in the 0.5-mg and 1.0-mg treatment arms, respectively, achieved the primary endpoint. Both were significantly greater than the 4.4-percent success rate in the placebo group (p<0.001 for both).
The principal efficacy of BOT remained consistent across subgroups and was generally robust to stratification according to concomitant proton pump inhibitor use and the localization of inflammation when induction treatment was started. Histologic remission in the active treatment groups was likewise maintained across all oesophageal segments analysed.
Secondary endpoints likewise confirmed the superiority of both BOT doses over placebo. Histologic relapse, for instance, was significantly more common in the placebo arm, as was clinical relapse (p<0.001 for all).
BOT was safe and brought upon no serious drug-related adverse events (AEs). Most of the AEs were unrelated to the test drug and occurred with comparable rates among all three groups.