医学
鼻息肉
嗜酸性阳离子蛋白
嗜酸性粒细胞
安慰剂
胃肠病学
嗜酸性粒细胞趋化因子
内科学
白细胞介素5
药代动力学
鼻腔给药
鼻粘膜
白细胞介素
免疫学
药理学
病理
细胞因子
哮喘
替代医学
作者
Philippe Gevaert,Doris Lang‐Loidolt,Andreas Lackner,Heinz R. Stammberger,Heribert Staudinger,Thibaut Van Zele,Gabriële Holtappels,Jan Tavernier,Paul Van Cauwenberge,Claus Bachert
标识
DOI:10.1016/j.jaci.2006.05.031
摘要
Chronic rhinosinusitis with nasal polyps is characterized by an eosinophilic inflammation and high IL-5 levels.Antagonizing the effect of IL-5 is a potential new treatment strategy in patients with nasal polyps.In a double-blind, placebo-controlled, randomized, 2-center safety and pharmacokinetic study, 24 subjects with bilateral nasal polyps were randomized to receive a single intravenous infusion of reslizumab, a humanized anti-human IL-5 mAb, at 3 mg/kg or 1 mg/kg or placebo. We evaluated the safety and pharmacokinetics of reslizumab, and biologic activity was assessed by means of endoscopic evaluation of polyp size, symptoms, peripheral eosinophil counts, peripheral and local IL-5 levels, eotaxin levels, and eosinophil cationic protein levels.We demonstrated that a single injection of reslizumab up to 3 mg/kg is safe and well tolerated. Blood eosinophil numbers and concentrations of eosinophil cationic protein were reduced up to 8 weeks after treatment in serum and nasal secretions. Individual nasal polyp scores improved only in half of the treated patients for 4 weeks. Responders had increased IL-5 concentrations in nasal secretions at baseline compared with nonresponders, and logistic regression analysis revealed that increased nasal IL-5 levels (>40 pg/mL) predict the response to anti-IL-5 treatment.A single injection of anti-IL-5 reduces the size of nasal polyps for 4 weeks in half of the patients, and nasal IL-5 levels predict the response to anti-IL-5 treatment.Intravenous administration of a humanized anti-human IL-5 mAb is safe and reduces the size of nasal polyps in half of the patients.
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