基于嗜酸性粒细胞基线计数研究莫米松/茚达特罗/格隆溴铵对控制不足哮喘患者的疗效：IRIDIUM研究的事后分析
2023/10/25
摘要
背景：基线特征可能指导哮喘治疗。本研究评估了基线嗜酸性粒细胞水平可否影响莫米松/茚达特罗/格隆溴铵（MF/IND/GLY）治疗哮喘控制不足患者的疗效。
方法：在这项IRIDIUM研究的事后分析中，比较不同基线外周血嗜酸性粒细胞计数亚组（＜300个/μL和≥300个/μL）患者应用高剂量MF/IND/GLY（160/150/50μg，每日一次[o.d.]）与高剂量MF/IND（320/150μg，每日一次）、高剂量氟替卡松/沙美特罗（FLU/SAL[500/50μg，每日两次[b.i.d.]）的疗效。
结果：本研究共纳入3065名患者。在第26周，高剂量MF/IND/GLY与高剂量MF/IND（Δ78mL[＜300个/μL]；Δ54mL[≥300个/μL]）和FLU/SAL（Δ112mL[＜300个/μL]；Δ98mL[≥300个/μL]）相比，谷FEV1有所改善。同样，与联用MF/IND相比，联用MF/IND/GLY也显示谷FEV1改善（Δ75mL[<300个/μL]；Δ68mL[≥300个/μL]）。在52周内，高剂量MF/IND/GLY与高剂量MF/IND相比，可使外周血嗜酸性粒细胞＜300个/μL和≥300个/μL的亚组的中重度哮喘年发作率分别降低23%和10%，严重发作率分别降低31%和15%，全发作率分别降低33%和10%；而与FLU/SAL相比，分别降低了33%和41%、45%和42%、42%和39%。同样，与合联用MF/IND相比，联用MF/IND/GLY可使各亚组急性发作率分别降低22%和8%、21%和7%、27%和8%。
结论：与MF/IND和FLU/SAL相比，MF/IND/GLY可改善肺功能并减少哮喘恶急性发作，且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在哮喘控制不足患者中的疗效。
Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study.
Kostikas K, Maspero JF, Chapman KR, Mezzi K, Jaumont X, Lawrence D, van Zyl-Smit R.
Abstract
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.
CONCLUSION: 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.
背景：基线特征可能指导哮喘治疗。本研究评估了基线嗜酸性粒细胞水平可否影响莫米松/茚达特罗/格隆溴铵（MF/IND/GLY）治疗哮喘控制不足患者的疗效。
方法：在这项IRIDIUM研究的事后分析中，比较不同基线外周血嗜酸性粒细胞计数亚组（＜300个/μL和≥300个/μL）患者应用高剂量MF/IND/GLY（160/150/50μg，每日一次[o.d.]）与高剂量MF/IND（320/150μg，每日一次）、高剂量氟替卡松/沙美特罗（FLU/SAL[500/50μg，每日两次[b.i.d.]）的疗效。
结果：本研究共纳入3065名患者。在第26周，高剂量MF/IND/GLY与高剂量MF/IND（Δ78mL[＜300个/μL]；Δ54mL[≥300个/μL]）和FLU/SAL（Δ112mL[＜300个/μL]；Δ98mL[≥300个/μL]）相比，谷FEV1有所改善。同样，与联用MF/IND相比，联用MF/IND/GLY也显示谷FEV1改善（Δ75mL[<300个/μL]；Δ68mL[≥300个/μL]）。在52周内，高剂量MF/IND/GLY与高剂量MF/IND相比，可使外周血嗜酸性粒细胞＜300个/μL和≥300个/μL的亚组的中重度哮喘年发作率分别降低23%和10%，严重发作率分别降低31%和15%，全发作率分别降低33%和10%；而与FLU/SAL相比，分别降低了33%和41%、45%和42%、42%和39%。同样，与合联用MF/IND相比，联用MF/IND/GLY可使各亚组急性发作率分别降低22%和8%、21%和7%、27%和8%。
结论：与MF/IND和FLU/SAL相比，MF/IND/GLY可改善肺功能并减少哮喘恶急性发作，且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在哮喘控制不足患者中的疗效。
(中日友好医院呼吸与危重症医学科 张婧媛 摘译 林江涛 审校)
(Respir Med. 2023 Oct;217:107334. doi: 10.1016/j.rmed.2023.107334.)
(Respir Med. 2023 Oct;217:107334. doi: 10.1016/j.rmed.2023.107334.)
Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study.
Kostikas K, Maspero JF, Chapman KR, Mezzi K, Jaumont X, Lawrence D, van Zyl-Smit R.
Abstract
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.
CONCLUSION: 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.
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