美波利祖马布
安慰剂
医学
吞咽困难
内科学
嗜酸性食管炎
胃肠病学
不利影响
随机对照试验
安慰剂对照研究
嗜酸性粒细胞
外科
双盲
病理
哮喘
替代医学
疾病
作者
Evan S. Dellon,Kathryn A. Peterson,Benjamin Mitlyng,Alina Iuga,Christine Bookhout,Lindsay Cortright,Kim Walker,Timothy Gee,Sasha McGee,Barbara Cameron,Joseph A. Galanko,John T. Woosley,Swathi Eluri,Susan E. Moist,Ikuo Hirano
出处
期刊:Gut
[BMJ]
日期:2023-07-09
卷期号:72 (10): 1828-1837
被引量:14
标识
DOI:10.1136/gutjnl-2023-330337
摘要
We aimed to determine whether mepolizumab, an anti-IL-5 antibody, was more effective than placebo for improving dysphagia symptoms and decreasing oesophageal eosinophil counts in eosinophilic oesophagitis (EoE).We conducted a multicentre, randomised, double-blind, placebo-controlled, trial. In the first part, patients aged 16-75 with EoE and dysphagia symptoms (per EoE Symptom Activity Index (EEsAI)) were randomised 1:1 to 3 months of mepolizumab 300 mg monthly or placebo. Primary outcome was change in EEsAI from baseline to month 3 (M3). Secondary outcomes included histological, endoscopic and safety metrics. In part 2, patients initially randomised to mepolizumab continued 300 mg monthly for 3 additional months (mepo/mepo), placebo patients started mepolizumab 100 mg monthly (pbo/mepo), and outcomes were reassessed at month 6 (M6).Of 66 patients randomised, 64 completed M3, and 56 completed M6. At M3, EEsAI decreased 15.4±18.1 with mepolizumab and 8.3±18.0 with placebo (p=0.14). Peak eosinophil counts decreased more with mepolizumab (113±77 to 36±43) than placebo (146±94 to 160±133) (p<0.001). With mepolizumab, 42% and 34% achieved histological responses of <15 and ≤6 eos/hpf compared with 3% and 3% with placebo (p<0.001 and 0.02). The change in EoE Endoscopic Reference Score at M3 was also larger with mepolizumab. At M6, EEsAI decreased 18.3±18.1 points for mepo/mepo and 18.6±19.2 for pbo/mepo (p=0.85). The most common adverse events were injection-site reactions.Mepolizumab did not achieve the primary endpoint of improving dysphagia symptoms compared with placebo. While eosinophil counts and endoscopic severity improved with mepolizumab at 3 months, longer treatment did not yield additional improvement.NCT03656380.
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