背景:基线特征可能指导哮喘治疗。我们评估了基线嗜酸性粒细胞水平是否影响莫米松/茚达特罗/格隆铵(MF/IND/GLY)对哮喘控制不充分的患者的疗效。
方法:在对IRIDIUM研究的事后分析中,高剂量MF/IND/GLY(160/150/50μg,每日一次[o.d.])与高剂量MF/IND(320/150μgo.d.)和高剂量氟替卡松/沙美特罗(FLU/SAL[500/50μg,每天两次[b.i.d.]);在基线血液嗜酸性粒细胞计数<300个细胞/μL或≥300个细胞/μL的患者亚组中,评估了合并MF/IND/GLY(160/150/50μg和80/150μg)与合并MF/IND(320/150μg和160/150μg)的疗效。
结果:总体而言,纳入3065例患者。在第26周,高剂量MF/IND/GLY与高剂量MF/IND(Δ78mL[<300个细胞/μL];Δ54mL[≥300个细胞/μL])和FLU/SAL(Δ112mL[<300个细胞/μL];Δ98mL[≥300个细胞/μL])相比,显示出改善的FEV1谷。同样,合并的MF/IND/GLY也显示出与合并的MF/IND相比改善的FEV1谷(Δ75mL[<300个细胞/μL];Δ68mL[≥300个细胞/μL])。超过52周,大剂量MF/IND/GLY将中度或重度哮喘急性发作的年发生率降低了23%和10%,严重加重31%和15%,对于<300细胞/uL和≥300细胞/uL的亚组,与高剂量MF/IND相比,所有恶化分别为33%和10%,分别为33%和41%,45%和42%,42%和39%与FLU/SAL相比,分别。同样,合并的MF/IND/GLY将恶化率降低了22%和8%,21%和7%,27%和8%,与合并的MF/IND相比,对于各自的子组。
结论:MF/IND/GLY显示,与MF/IND和FLU/SAL相比,肺功能改善,哮喘加重减少,与基线嗜酸性粒细胞水平无关,表明嗜酸性粒细胞水平不影响MF/IND/GLY在哮喘控制不充分患者中的疗效。
背景:ClinicalTrials.gov,NCT02571777(IRIDIUM)。
BACKGROUND: Baseline characteristics could potentially guide asthma treatments. We evaluated whether baseline eosinophil levels affect the efficacy of mometasone/indacaterol/glycopyrronium (MF/IND/GLY) in patients with inadequately controlled asthma.
METHODS: In this post hoc analysis of IRIDIUM study, efficacy of high-dose MF/IND/GLY (160/150/50 μg, once-daily [o.d.]) versus high-dose MF/IND (320/150 μg o.d.) and high-dose fluticasone/salmeterol (FLU/SAL [500/50 μg, twice-daily [b.i.d.]); and efficacy of pooled MF/IND/GLY (160/150/50 μg and 80/150/50 μg) versus pooled MF/IND (320/150 μg and 160/150 μg) was evaluated in patient subgroups with baseline blood eosinophil count of <300 cells/μL or ≥300 cells/μL.
RESULTS: Overall, 3065 patients were included. At Week 26, high-dose MF/IND/GLY showed improved trough FEV1 versus high-dose MF/IND (Δ78mL [<300 cells/μL]; Δ54mL [≥300 cells/μL]) and FLU/SAL (Δ112mL [<300 cells/μL]; Δ98mL [≥300 cells/μL]). Similarly, pooled MF/IND/GLY also showed improved trough FEV1 versus pooled MF/IND (Δ75mL [<300 cells/μL]; Δ68mL [≥300 cells/μL]). Over 52 weeks, high-dose MF/IND/GLY reduced the annualized rate of moderate or severe asthma exacerbations by 23% and 10%, severe exacerbations by 31% and 15%, and all exacerbation by 33% and 10% versus high-dose MF/IND for subgroups with <300 cells/μL and ≥300 cells/μL, respectively; and by 33% and 41%, 45% and 42%, 42% and 39% versus FLU/SAL, respectively. Similarly, pooled MF/IND/GLY reduced exacerbations by 22% and 8%, 21% and 7%, 27% and 8%, versus pooled MF/IND, for the respective subgroups.
CONCLUSIONS: MF/IND/GLY showed improvement in lung function and reduction in asthma exacerbations over MF/IND and FLU/SAL independent of baseline eosinophil levels, indicating that eosinophil levels did not affect the efficacy of MF/IND/GLY in patients with inadequately controlled asthma.
BACKGROUND: ClinicalTrials.gov, NCT02571777 (IRIDIUM).