Reslizumab哮喘控制不足与高血嗜酸性粒细胞计数:结果从两个多中心平行,双盲,随机,安慰剂对照,第三阶段试验。

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卡斯特罗M, Zangrilli J,韦氏我,贝特曼,Brusselle GG, Bardin P,墨菲K, Maspero摩根富林明,O ' brien C,科恩

Reslizumab哮喘控制不足与高血嗜酸性粒细胞计数:结果从两个多中心平行,双盲,随机,安慰剂对照,第三阶段试验。

柳叶刀和地中海。2015;3 (5):355 - 66。doi: 10.1016 / s2213 - 2600 (15) 00042 - 9。Epub 2015年2月23日。

PubMed ID

25736990 (在PubMed

]

文摘

背景:升高的血嗜酸性粒细胞哮喘急性加重的危险因素。Reslizumab是人性化anti-interleukin 5单克隆抗体破坏嗜酸性粒细胞成熟,促进程序性细胞死亡。我们旨在评估的有效性和安全性reslizumab不足患者控制,严重哮喘。方法:我们做了两个重复的、多中心、双盲、随机、安慰剂对照与这些相应平行的组织,第三阶段试验。都试验了哮喘患者年龄在12 - 75年(从128年临床研究中心在研究1和104年中心在研究2)来自亚洲、澳大利亚、北美,南美,南非,和欧洲的哮喘是由中级到高级控制剂量吸入激素不足的基础治疗和血液嗜酸性粒细胞的400细胞/或更高版本和一个或多个前一年发作。病人被随机分配(1:1)接受静脉注射reslizumab(3.0毫克/公斤)或安慰剂每4周为1年计算机中央随机。病人和调查人员掩蔽治疗分配在研究过程中。每个病人收到具体体积的研究药物(reslizumab或匹配的安慰剂)的基础上,患者的体重和随机分配治疗组。此外,赞助的临床研究人员参与这项研究被掩盖药物的身份,直到数据库被锁分析和处理任务显示。主要结果是一年一度的临床哮喘发作的频率和被意图治疗分析。 We assessed safety outcomes in the patients who had received one or more dose of the drug. The trials have been completed and are registered with ClinicalTrials.gov, numbers NCT01287039 (study 1) and NCT01285323 (study 2). FINDINGS: Study 1 was done between April 12, 2011, and March 3, 2014 and study 2 between March 22, 2011, and April 9, 2014. Of 2597 patients screened, 953 were randomly assigned to receive either reslizumab (n=477 [245 in study 1 and 232 in study 2]) or placebo (n=476 [244 and 232]). In both studies, patients receiving reslizumab had a significant reduction in the frequency of asthma exacerbations (study 1: rate ratio [RR] 0.50 [95% CI 0.37-0.67]; study 2: 0.41 [0.28-0.59]; both p<0.0001) compared with those receiving placebo. Common adverse events on reslizumab were similar to placebo. The most common adverse events were worsening asthma symptoms (127 [52%] for placebo and 97 [40%] for reslizumab in study 1; 119 [51%] for placebo and 67 [29%] for reslizumab for study 2), upper respiratory tract infections (32 [13%] and 39 [16%]; 16 [7%] and eight [3%]), and nasopharyngitis (33 [14%] and 28 [11%]; 56 [24%] and 45 [19%]). Two patients in the reslizumab group had anaphylactic reactions; both responded to standard treatment at the study centre and resolved, and the patients were withdrawn from the study. INTERPRETATION: These results support the use of reslizumab in patients with asthma and elevated blood eosinophil counts who are inadequately controlled on inhaled corticosteroid-based therapy. FUNDING: Teva Branded Pharmaceutical Products R&D.

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药物

Reslizumab