Background A post hoc analysis of two randomized, placebo-controlled, Phase 3 trials of intravenous reslizumab, an anti-interleukin-5 (IL-5) biologic for severe eosinophilic asthma. Methods Relationships between baseline blood eosinophil levels (EOS), forced expiratory volume in 1 s (FEV1) reversibility to β2-agonists and treatment outcomes were assessed. Results Mean baseline FEV1 reversibility was numerically lower among patients with high (≥ 400 cells/µL) versus low baseline EOS. Reslizumab produced clinically significant improvement in FEV1, exacerbation rates and patient-reported outcomes after 52 weeks, including in patients with high EOS and low FEV1 reversibility (≤ 14%) to β2-agonists at baseline. Conclusions Clinical trial eligibility criteria stipulating minimum FEV1 reversibility to β2-agonists of ≥ 12% might exclude patients who would benefit from treatment with anti-IL-5 biologics.

中文翻译：

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在 reslizumab 临床试验中患有嗜酸性粒细胞增多症的重度哮喘患者中，外周血嗜酸性粒细胞水平高与 FEV1 可逆性低相关。

背景 对两项随机、安慰剂对照、3 期静脉注射 reslizumab 试验的事后分析，reslizumab 是一种用于治疗严重嗜酸性粒细胞性哮喘的抗白细胞介素 5 (IL-5) 生物制剂。方法 评估基线血嗜酸性粒细胞水平 (EOS)、1 秒用力呼气量 (FEV1) 对 β2 受体激动剂的可逆性和治疗结果之间的关系。结果 与低基线 EOS 相比，高（≥ 400 个细胞/µL）患者的平均基线 FEV1 可逆性在数值上较低。Reslizumab 在 52 周后对 FEV1、恶化率和患者报告的结果产生了临床上的显着改善，包括在基线时对 β2 受体激动剂具有高 EOS 和低 FEV1 可逆性（≤14%）的患者。