Dataset Information

Efficacy and Safety of Budesonide in the Treatment of Eosinophilic Esophagitis: Updated Systematic Review and Meta-Analysis of Randomized and Non-Randomized Studies.

ABSTRACT:

Background and objective

Eosinophilic esophagitis (EE) is an immune/antigen-driven inflammation that causes esophageal dysfunction. Budesonide has shown promising effect in the management of EE in multiple studies, and we therefore conducted this systematic review/meta-analysis to assess budesonide efficacy and safety in order to provide more updated and robust evidence.

Methods

In April 2018, we conducted a systematic electronic search through four databases: PubMed, Scopus, Web of Science (ISI), and Cochrane Central. All original studies reporting the efficacy of budesonide in the treatment of EE were included in our meta-analysis. The Cochrane Collaboration tool was employed to assess the risk of bias among included randomized controlled trials, while the Newcastle-Ottawa Scale was used for non-randomized studies.

Results

A total of 12 studies including 555 participants were included in our review. Budesonide showed marked efficacy at the level of histological response compared to placebo [risk ratio (RR) (95% confidence interval (CI)) 11.93 (4.82-29.50); p > 0.001]. Analysis of randomized and non-randomized studies revealed considerable reduction in eosinophil count, with a mean difference (MD) (95% CI) of - 69.41 (- 105.31 to - 33.51; p < 0.001) and 46.85 (33.93-59.77; p < 0.001), respectively. Similarly, there was a marked improvement in the clinical symptoms via the analysis of randomized and non-randomized studies, with an RR (95% CI) of 1.72 (1.22-2.41; p = 0.002) and MD (95% CI) of 2.45 (0.76-4.15; p = 0.005), respectively.

Conclusion

Budesonide showed significant effect at all treatment endpoints. However, since budesonide carries a risk of candidiasis and our inferences are based only on a small number of included studies, more research is warranted to clarify these results.

SUBMITTER: Rawla P

PROVIDER: S-EPMC6277325 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Publications

Efficacy and Safety of Budesonide in the Treatment of Eosinophilic Esophagitis: Updated Systematic Review and Meta-Analysis of Randomized and Non-Randomized Studies.

Rawla Prashanth P Sunkara Tagore T Thandra Krishna Chaitanya KC Gaduputi Vinaya V

Drugs in R&D 20181201 4

<h4>Background and objective</h4>Eosinophilic esophagitis (EE) is an immune/antigen-driven inflammation that causes esophageal dysfunction. Budesonide has shown promising effect in the management of EE in multiple studies, and we therefore conducted this systematic review/meta-analysis to assess budesonide efficacy and safety in order to provide more updated and robust evidence.<h4>Methods</h4>In April 2018, we conducted a systematic electronic search through four databases: PubMed, Scopus, Web ...[more]

PMID: 30387081

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Project description:BackgroundRelapse after corticosteroid withdrawal in eosinophilic esophagitis is not well understood.ObjectivesBudesonide oral suspension (BOS) 2.0 mg twice daily (b.i.d.) was evaluated in two consecutive phase III studies (12 and 36 weeks, respectively). For clinicopathologic responders after 12 weeks of BOS treatment, we assessed randomized treatment withdrawal for up to 36 weeks of therapy.DesignPost hoc analysis of a phase III, double-blind, randomized withdrawal study.MethodsClinicopathologic responders (⩽6 eosinophils per high-power field (eos/hpf) and ⩾30% reduction in Dysphagia Symptom Questionnaire (DSQ) score from baseline) after 12 weeks of BOS were randomized to continue BOS 2.0 mg b.i.d. (BOS-BOS) or withdraw to placebo (PBO; BOS-PBO) for up to 36 weeks. Relapsers (⩾15 eos/hpf (⩾2 esophageal regions) and ⩾4 days of dysphagia (DSQ)) could reinitiate BOS 2.0 mg b.i.d. This post hoc analysis assessed a more clinically relevant relapse definition (⩾15 eos/hpf (⩾1 esophageal region) and ⩾4 days of dysphagia (DSQ)) for BOS-BOS versus BOS-PBO patients over 36 weeks. To account for BOS-PBO patients who reinitiated BOS before week 36, patients' last observations before reinitiating BOS were carried forward (last observation carried forward (LOCF)) for histologic, symptom, and endoscopic efficacy endpoints (at weeks 12 and 36).ResultsOf 48 patients included (BOS-BOS, n = 25; BOS-PBO, n = 23), significantly more BOS-PBO than BOS-BOS patients relapsed over 36 weeks using this post hoc relapse definition (60.9% vs 28.0%; p = 0.022). More BOS-BOS than BOS-PBO patients maintained histologic responses (all thresholds) and showed improvements in symptom and endoscopic efficacy endpoints.ConclusionMore BOS-PBO than BOS-BOS patients relapsed, determined by a more clinically relevant post hoc relapse definition. Using LOCF, more BOS-BOS than BOS-PBO patients also maintained or had improvements in efficacy endpoints.Trial registrationClinicalTrials.gov identifiers (https://clinicaltrials.gov/): NCT02605837, NCT02736409.

Dataset Information

Efficacy and Safety of Budesonide in the Treatment of Eosinophilic Esophagitis: Updated Systematic Review and Meta-Analysis of Randomized and Non-Randomized Studies.

Background and objective

Methods

Results

Conclusion

Publications

Efficacy and Safety of Budesonide in the Treatment of Eosinophilic Esophagitis: Updated Systematic Review and Meta-Analysis of Randomized and Non-Randomized Studies.

Similar Datasets

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