用本拉利祖马布治疗埃索诺菲尔食道炎的埃索诺菲尔枯竭
Marc E Rothenberg1, Evan S Dellon1, Margaret H Collins1
1From the Divisions of Allergy and Immunology (M.E.R., J.M.C.) and Pathology and Laboratory Medicine (M.H.C.), Department of Pediatrics, and the Department of Pathology and Laboratory Medicine (M.H.C.), University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati; the Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill (E.S.D.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam (A.J.B.); the Kenneth C. Griffin Esophageal Center, Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago (I.H.); the Division of Gastroenterology, Department of Internal Medicine, University of Utah, Salt Lake City (K.A.P.); Late-Stage Respiratory and Immunology, BioPharmaceuticals Research and Development, AstraZeneca, Cambridge, United Kingdom (L.B.); Late-Stage Respiratory and Immunology, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (H.F., H.G.); and Patient Centered Science, BioPharmaceuticals Medical Evidence (C.N.H.), Late-stage Respiratory and Immunology (M.K., C.J.D.) and Translational Science and Experimental Medicine, Early Respiratory and Immunology (C.M.), BioPharmaceuticals Research and Development, and Data Sciences and AI (D.S.) and Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences (W.I.W.), Research and Development, AstraZeneca, Gaithersburg, MD.
贝纳利祖马布在性食道炎患者中有效地实现了组织学缓解. 然而,与安慰剂相比,这种降低乙氨基酸的疗法并没有显著改善食障碍症状.
科学领域:
- 胃肠病学 胃肠病学
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 性食道炎 (EoE) 是一种慢性炎症状况.
- 贝纳利祖马布准了互白素-5受体α,从而消耗了埃索诺菲尔细胞.
- 本拉利祖马布在治疗EoE中的作用需要进一步研究.
研究的目的:
- 为了评估本拉利祖马布在患有异性食道炎的患者中的疗效和安全性.
- 评估使用本拉利祖马布治疗的EoE患者的组织学反应和症状改善.
主要方法:
- 一个第三期,多中心,双盲,随机,安慰剂对照试验.
- 211名年龄在12-65岁之间的患者有活跃的EoE,每4周接受本拉利祖马布或安慰剂的皮下注射.
- 主要终点包括组织学反应和24周时失调症状问卷 (DSQ) 得分的变化.
主要成果:
- 在第24周,本拉利祖马布表现出显著更高的组织学反应率 (87.4%) 与安慰剂 (6.5%) 相比 (P<0.001).
- 在本拉利祖马布和安慰剂组之间从基线DSQ得分的变化中没有观察到显著差异.
- 两组之间不良事件的发生率相似,没有因不良事件而停止治疗.
结论:
- 贝纳利祖马布显著改善了埃索诺菲尔性食道炎的组织学标记.
- 尽管发生了组织学上的改善,但本拉利祖马布并没有导致缺食症的显著症状改善.
- 需要进一步的研究来了解本拉利祖马布在EoE管理中的临床影响.
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