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Omalizumab in patients with severe asthma and persistent sputum eosinophilia

机译:奥马珠单抗用于重度哮喘和持续性痰嗜酸性粒细胞增多的患者

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摘要

Omalizumab, a recombinant humanized monoclonal antibody targeting the IgE molecule, is the first biologic approved for moderate-to-severe allergic asthmatics, who remain uncontrolled despite high dose inhaled corticosteroid and bronchodilators. Steroid-sparing effect of omalizumab has not been demonstrated in asthmatics with persistent airway eosinophilia in a randomised controlled trial till date. From this double-blind, placebo-controlled, multi-centred, randomized parallel group design, we report that omalizumab is possibly inadequate to control sputum eosinophilia, and therefore may not have a steroid-sparing effect, especially in those maintained on oral corticosteroids daily. This needs to be confirmed or refuted in a larger trial, which may be a challenge with respect to recruitment, since there are currently three additional biologics available to prescribe.Trial registration Clinicaltrials.gov, , Registered 30th January 2014, https://clinicaltrials.gov/ct2/show/Electronic supplementary materialThe online version of this article (10.1186/s13223-019-0337-2) contains supplementary material, which is available to authorized users.
机译:靶向IgE分子的重组人源化单克隆抗体Omalizumab是首个被批准用于中度至重度过敏性哮喘的生物制剂,尽管高剂量吸入皮质类固醇和支气管扩张剂,哮喘仍不受控制。迄今为止,尚未在持续气道嗜酸性粒细胞增多的哮喘患者中证明奥马珠单抗的类固醇保护作用。从这种双盲,安慰剂对照,多中心,随机平行组设计中,我们报道了奥马珠单抗可能不足以控制痰嗜酸性粒细胞增多,因此可能没有类固醇的保护作用,尤其是在每天口服皮质类固醇维持的情况下。这需要在更大的试验中予以确认或驳斥,这可能对招募而言是一个挑战,因为目前还有另外三种生物制剂可供使用。试验注册Clinicaltrials.gov,,2014年1月30日注册,https:// clinicaltrials .gov / ct2 / show /电子补充材料本文的在线版本(10.1186 / s13223-019-0337-2)包含补充材料,授权用户可以使用。

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