贝纳利祖马布对比梅波利祖马布治疗多炎带来的埃索诺菲尔粒状瘤症
Michael E Wechsler1, Parameswaran Nair1, Benjamin Terrier1
1From the Department of Medicine, National Jewish Health, Denver (M.E.W.); McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (P.N.); the Department of Internal Medicine, National Referral Center for Rare Systemic Autoimmune Diseases, Hospital Cochin, and Université Paris Cité, Paris (B.T.), and the Department of Respiratory Diseases, University of Montpellier, Centre Hospitalier Universitaire Montpellier, INSERM, Centre National de la Recherche Scientifique, Montpellier (A.B.) - all in France; the Department of Internal Medicine, Rheumatology, and Immunology, Medius Kliniken, University of Tübingen, Kirchheim-Teck, Germany (B.W.); the Department of Medicine, University of Cambridge (D.R.W.J.), and BioPharmaceuticals Medical (A.S.) and Late-Stage Respiratory and Immunology, BioPharmaceuticals Research and Development (C.W.), AstraZeneca, Cambridge, and Guy's Severe Asthma Centre, School of Immunology and Microbial Sciences, King's College London, London (D.J.J.) - all in the United Kingdom; the Department of Internal Medicine, Hôpital Erasme, Université Libre de Bruxelles, Brussels (F.R.); Late-Stage Respiratory and Immunology, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (L.B.S., S.N.); Late-Stage Respiratory and Immunology, BioPharmaceuticals Research and Development (Y.F., M.J.), and Translational Science and Experimental Medicine, Early Respiratory and Immunology, BioPharmaceuticals Research and Development (C.M.), AstraZeneca, Gaithersburg, MD; and the Division of Rheumatology, Department of Medicine, and the Division of Epidemiology, Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M.).
贝纳利祖马布在实现聚炎 (EGPA) 带来的埃索诺菲尔粒状瘤病的缓解方面表现出与梅波利祖马布的非劣势. 这两种治疗方法在这个第三阶段试验中显示出相似的缓解持续时间和复发时间.
科学领域:
- 免疫学 免疫学 免疫学
- 类风湿病学 类风湿病学
- 临床试验 临床试验
背景情况:
- 带有多炎的异性粒状炎 (EGPA) 是一种罕见的血管炎,以异性炎症为特征.
- 贝纳利祖马布向埃索诺菲尔细胞上的互白素-5α受体,为EGPA提供了潜在的治疗途径.
研究的目的:
- 评估本拉利祖马布的疗效和安全性,与成人复发性或耐火性EGPA的mepolizumab相比.
- 确定本拉利祖马布在诱导缓解方面是否与梅波利祖马布不劣.
主要方法:
- 这是一项多中心,双盲,随机,主控,非劣势性试验,涉及140名患EGPA的成年患者.
- 患者接受本拉利祖马布 (30毫克) 或梅波利祖马布 (300毫克) 的皮下注射,每4周注射一次,持续52周.
- 主要终点是第36周和第48周的缓解;次要终点包括缓解持续时间,复发时间,葡萄糖皮质类药物使用,乙氨基酸细胞计数和安全性.
主要成果:
- 在第36周和第48周实现缓解方面,本拉利祖马布 (59%) 与梅波利祖马布 (56%) 不逊 (差异:3个百分点;95% CI,-13到18).
- 完全的口服葡萄糖皮质类药物戒断在本拉利祖马布 (41%) 和梅波利祖马布 (26%) 之间更高.
- 这两种疗法都显著降低了乙氨基细胞的数量,而本拉利祖马布显示出更大的减少.
结论:
- 在患有复发性或耐火性EGPA的患者中,本拉利祖马布在诱导缓解方面与梅波利祖马布无劣.
- 贝纳利祖马布可能在实现完全口服葡萄糖皮质激素戒断方面具有优势.
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