Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study

Konstantinos Kostikas; Jorge F Maspero; Kenneth R Chapman; Karen Mezzi; Xavier Jaumont; David Lawrence; Richard van Zyl-Smit

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

Respir Med. 2023 Oct:217:107334. doi: 10.1016/j.rmed.2023.107334. Epub 2023 Jun 29.

Authors

Konstantinos Kostikas¹, Jorge F Maspero², Kenneth R Chapman³, Karen Mezzi⁴, Xavier Jaumont⁴, David Lawrence⁴, Richard van Zyl-Smit⁵

Affiliations

¹ Respiratory Medicine Department, University of Ioannina, Ioannina, Greece. Electronic address: [email protected].
² Allergy and Respiratory Research Unit, Fundación CIDEA, Buenos Aires, Argentina.
³ Division of Respiratory Medicine, Department of Medicine, University of Toronto, Toronto, Canada.
⁴ Novartis Pharma AG, Basel, Switzerland.
⁵ Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.

PMID: 37392789
DOI: 10.1016/j.rmed.2023.107334

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.

Method: 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.

Trial registration: ClinicalTrials.gov, NCT02571777 (IRIDIUM).

Keywords: Eosinophil; Exacerbations; Glycopyrronium bromide; Indacaterol acetate; Lung function; Mometasone furoate.

Associated data

ClinicalTrials.gov/NCT02571777