Abstract
BackgroundA 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.MethodsRelationships between baseline blood eosinophil levels (EOS), forced expiratory volume in 1 s (FEV1) reversibility to β2-agonists and treatment outcomes were assessed.ResultsMean 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.ConclusionsClinical 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.
Highlights
Severe non-allergic, adult-onset or intrinsic asthma is frequently associated with pronounced eosinophilia [1,2,3,4]
A total of 953 patients were randomized in the two duplicate Phase 3 studies
Patient demographics and clinical characteristics at baseline were similar between reslizumab and placebo groups (Table 1)
Summary
Severe non-allergic, adult-onset or intrinsic asthma is frequently associated with pronounced eosinophilia [1,2,3,4]. IL-5 activity has been demonstrated to inversely correlate with pulmonary function in patients with asthma [4], and anti-IL-5 treatment has been shown to improve asthma control in patients with severe asthma and eosinophilia [6]. In Phase 3 clinical trials intravenous (IV) reslizumab dosed at 3 mg/kg once every. 4 weeks (q4w) was associated with a significant reduction in the risk of clinical asthma exacerbations (CAEs) and improved asthma control, lung function, and quality of life in patients with inadequately controlled asthma with blood eosinophil levels (EOS) ≥ 400 cells/μL and a history of CAEs [8]. 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
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