Efficacy and Safety of Budesonide Orodispersible Tablets for Eosinophilic Esophagitis up to 3 Years: An Open-Label Extension Study.

IF 11.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Luc Biedermann, Christoph Schlag, Alex Straumann, Alfredo J Lucendo, Stephan Miehlke, Michael Vieth, Cecilio Santander, Constanza Ciriza de Los Rios, Christoph Schmöcker, Ahmed Madisch, Petr Hruz, Jamal Hayat, Ulrike von Arnim, Albert Jan Bredenoord, Stefan Schubert, Mike Halstead, Sabrina Pfurr, Ralph Mueller, Alain M Schoepfer, Stephen Attwood
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Abstract

Background & aims: Budesonide orodispersible tablets (BOT) have been shown to be safe and effective in phase III double-blind trials of induction and 48-week maintenance therapy of eosinophilic esophagitis (EoE). We now analyzed the long-term efficacy and safety of BOT in a 96-week open-label extension (OLE) study.

Methods: All patients with EoE in the 48-week double-blind maintenance study were eligible to receive BOT treatment for up to 96 weeks. Dosage was 0.5 or 1.0 mg BOT, twice daily, at investigator's discretion. Clinical, histologic, endoscopic, quality of life, and safety measures were assessed.

Results: A total of 186 patients participated in the OLE up to 96 weeks. At week 96, 81.9% of patients had clinical remission, defined as an EoE Symptom Activity Index (EEsAI) score of ≤20 vs 77.7% at OLE baseline. A further 80.1% of patients were in histologic remission, defined as peak eosinophils per high-power field of <5, at week 96 vs 91.8% at OLE baseline. Mean EoE endoscopic reference scores (EREFS) were 1 at all time points measured. Mean EoE Quality of Life (EoE-QoL-A) Scale scores improved from 3.3 at OLE baseline to 3.5 at week 96. No new safety concerns were observed across 96 weeks of treatment. Suspected symptomatic candidiasis occurred at similar rates to prior BOT studies and was predominantly mild and resolved with treatment.

Conclusions: Clinical and histologic remission of EoE could be maintained with BOT in a large majority of patients for up to 96 weeks, and for up to 144 weeks in patients with uninterrupted BOT therapy across all trials. No additional safety concerns were identified with long-term BOT treatment (ClinicalTrials.gov, Number: NCT02493335).

布地奈德口腔分散片治疗3年以上嗜酸性食管炎的疗效和安全性:一项开放标签扩展研究
背景和目的:布地奈德或分散片(BOT)在诱导和48周维持治疗嗜酸性食管炎(EoE)的3期双盲试验中被证明是安全有效的。我们现在在一项为期96周的开放标签延长(OLE)研究中分析了BOT的长期疗效和安全性。方法:在为期48周的双盲维持研究中,所有EoE患者均有资格接受BOT治疗长达96周。剂量为0.5或1.0 mg BOT,每日两次,由研究者自行决定。评估临床、组织学、内镜、生活质量和安全措施。结果:共有186例患者参加了为期96周的OLE。在第96周,81.9%的患者临床缓解,定义为EoE症状活动指数(EEsAI)评分≤20,而OLE基线时为77.7%。另外80.1%的患者处于组织学缓解,定义为每高倍视野的嗜酸性粒细胞峰值。结论:在所有试验中,绝大多数患者的临床和组织学缓解可以在BOT治疗下维持长达96周,在不间断BOT治疗的患者中可维持长达144周。长期BOT治疗未发现额外的安全性问题。(ClinicalTrials.gov,编号:NCT02493335)。
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来源期刊
CiteScore
16.90
自引率
4.80%
发文量
903
审稿时长
22 days
期刊介绍: Clinical Gastroenterology and Hepatology (CGH) is dedicated to offering readers a comprehensive exploration of themes in clinical gastroenterology and hepatology. Encompassing diagnostic, endoscopic, interventional, and therapeutic advances, the journal covers areas such as cancer, inflammatory diseases, functional gastrointestinal disorders, nutrition, absorption, and secretion. As a peer-reviewed publication, CGH features original articles and scholarly reviews, ensuring immediate relevance to the practice of gastroenterology and hepatology. Beyond peer-reviewed content, the journal includes invited key reviews and articles on endoscopy/practice-based technology, health-care policy, and practice management. Multimedia elements, including images, video abstracts, and podcasts, enhance the reader's experience. CGH remains actively engaged with its audience through updates and commentary shared via platforms such as Facebook and Twitter.
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