ArticleTherapeutic advances in gastroenterology2024
Effect of randomized treatment withdrawal of budesonide oral suspension on clinically relevant efficacy outcomes in patients with eosinophilic esophagitis: a post hoc analysis.
Article in Therapeutic advances in gastroenterology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study
A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE)
Who cites it
4 citing papers in PubMed.
- Variability in time to surveillance endoscopy for eosinophilic esophagitis remission and relation to treatment outcomes.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2026Article
- Real-World Clinical Efficacy of Food and Drug Administration-Approved Budesonide Oral Suspension Across Histologic, Endoscopic, and Symptomatic Outcomes.Gastro hep advances · 2026Article
- Orally Dispersible Swallowed Topical Corticosteroids in Eosinophilic Esophagitis: A Paradigm Shift in the Management of Esophageal Inflammation.Pharmaceutics · 2025Review
- Advances and Challenges in the Development of New and Novel Treatment Strategies for Eosinophilic Esophagitis (EoE).Pharmaceuticals (Basel, Switzerland) · 2025Review
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Relapse after corticosteroid withdrawal in eosinophilic esophagitis is not well understood. Objectives: Budesonide 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. Design: Post hoc analysis of a phase III, double-blind, randomized withdrawal study. Methods: Clinicopathologic 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). Results: Of 48 patients included (BOS-BOS, Conclusion: More 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 registration: ClinicalTrials.gov identifiers (https://clinicaltrials.gov/): NCT02605837, NCT02736409.
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Registered trials
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