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A double-blind, randomized, phase 3 trial was conducted to compare the safety and efficacy of two doses of BOT vs placebo in maintaining remission of eosinophilic esophagitis.
A phase 3 trial depicted that in
patients with eosinophilic esophagitis, treatment with budesonide
orodispersible tablet (BOT) (0.5 mg or 1.0 mg, twice daily) for up to 48 weeks
demonstrated superiority to placebo in
maintaining remission of eosinophilic esophagitis. Both the dosages were
well-tolerated and were found to be equally effective.
A double-blind, randomized, phase 3
trial was conducted to compare the safety and efficacy of two doses of BOT vs placebo in maintaining remission of
eosinophilic esophagitis.
From January 2016 to November 2018,
the study was conducted at 37 medical centers in 6 European countries. From 29
European study sites, 204 adults with eosinophilic esophagitis in clinical and
histologic remission were recruited. Participants were randomly allocated to
either BOT 0.5 mg twice daily (n=68), BOT 1.0 mg twice daily (n=68), or placebo
twice daily (n=68) for up to 48 weeks. Remission at week 48 was the primary
outcome parameter. Absence of clinical and histological relapse and no
premature withdrawal for any reason was defined as maintenance of remission.
For all the groups, the percentage of patients in persistent remission at the end of treatment is depicted in the following table and figure:
Notably, the median time to relapse in the placebo group was 87 days The Kaplan-Meier Analysis of time to clinical relapse is depicted in the following figure:
Both BOT and placebo groups demonstrated similarity in the
frequency of adverse events. Both doses of BOT were well tolerated and no
serious drug-emergent adverse events were witnessed.
At baseline, the morning serum levels of cortisol were in
the normal range and did not substantially alter during treatment.
Asymptomatic, low serum levels of cortisol developed in four patients receiving
BOT.
In 0.5 mg BOT group, the clinically manifested candidiasis was suspected in higher patients compared to 1.0 mg BOT group, as shown in the following table:
All the infections resolved with treatment.
BOT tablet is safe and effective for the treatment of eosinophilic
esophagitis and maintaining remission for as long as 48 weeks.
Gastroenterology
Budesonide Orodispersible Tablets Maintain Remission in a Randomized, Placebo-Controlled Trial of Patients With Eosinophilic Esophagitis
Alex Straumann et al.
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