杜皮卢马布治疗COPD与血液中乙氨基基细胞的II型炎症的证据
Surya P Bhatt1, Klaus F Rabe1, Nicola A Hanania1
1From the Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham (S.P.B.); LungenClinic Grosshansdorf (member of the German Center for Lung Research [DZL]), Airway Research Center North (ARCN), Grosshansdorf (K.F.R.), Christian-Albrechts University, DZL, ARCN, Kiel (K.F.R.), and the Department of Medicine, Pulmonary and Critical Care Medicine, University of Marburg, DZL, Marburg (C.F.V.) - all in Germany; the Section on Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston (N.A.H.); King's Centre for Lung Health, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, London (M.B.), and the Medicines Evaluation Unit, Manchester University NHS Foundation Trust, University of Manchester, Manchester (D.S.) - both in the United Kingdom; the Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine, University of California, San Francisco, San Francisco (S.A.C.); the Respiratory Medicine Unit, University of Ferrara, S. Anna University Hospital, Ferrara, Italy (A.P.); Sanofi, Bridgewater, NJ (E.L., X.L., D.B.); Sanofi, Cambridge, MA (N.P., R.M.A., L.B.R.); and Regeneron Pharmaceuticals, Tarrytown, NY (G.D.Y., B.A., J.M., A.B.).
在患有慢性阻塞性肺病 (COPD) 和2型炎症的患者中,dupilumab显著降低了恶化和改善了肺功能. 这证实了它的有效性,在管理COPD与高色素细胞计数.
科学领域:
- 肺部病理学 肺部病理学
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 慢性阻塞性肺病 (COPD) 通常是由2型炎症驱动的.
- 杜皮卢马布向2型炎症的关键介导体,即白内素-4和白内素-13.
- 以前的试验表明dupilumab在患有2型炎症的COPD患者中的有效性.
研究的目的:
- 为了确认dupilumab的有效性和安全性,在第二个COPD患者的第3期试验中对COPD患者进行了第二类炎症.
- 评估dupilumab对恶化率和肺功能的影响.
主要方法:
- 一项3期,双盲,随机试验,涉及935名COPD患者,血液中乙酸细胞计数≥300细胞/μL.
- 患者每隔两周接受皮下杜皮卢马布 (300毫克) 或安慰剂.
- 主要终点:中度/严重恶化的年率. 二级终点:FEV1和SGRQ分数的变化.
主要成果:
- 与安慰剂相比,dupilumab可将年化恶化率降低34% (0.86对1.30恶化/年;速率比0.66;P<0.001).
- 与安慰剂相比,dupilumab在第12周和第52周显著改善了支气管扩展前FEV1 (第12周的平均差异为82毫升;第52周的平均差异为62毫升).
- 在SGRQ得分上没有显著差异;两组之间不良事件概况相似.
结论:
- 杜皮卢马布在减少恶化和改善COPD患者的肺功能方面是有效的,COPD患者有2型炎症和升高的乙氨基酸.
- 这些发现支持dupilumab作为这种特定的COPD患者群体的治疗选择.
- 在这项试验中,dupilumab的安全性概况与之前的研究一致.
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