Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses

Overview

Journal Pulm Ther

Publisher Springer

Date 2023 Aug 1

PMID 37526856

Authors

Richard N van Zyl-Smit

Huib A M Kerstjens

Jorge Maspero

Ana-Maria Tanase

David Lawrence

Karen Mezzi

Peter DAndrea

Kenneth R Chapman

Affiliations

Soon will be listed here.

Abstract

Introduction: GINA guidelines recommend increasing the dose of inhaled corticosteroids (ICS) as a step-up option for patients with inadequately controlled asthma at GINA step 4 [inadequately controlled asthma on medium-dose ICS/long-acting beta-2 agonist (LABA)]. The aim of this study was to compare the efficacy and safety of long-acting muscarinic antagonists (LAMA) add-on to medium-dose ICS/LABA in patients at GINA 2022 step 4.

Methods: This post hoc analysis of the IRIDIUM study evaluated the change from baseline in trough forced expiratory volume (FEV ) in patients receiving medium-dose MF/IND/GLY versus high-dose MF/IND and high-dose FLU/SAL at Week 26. Other outcomes included improvement in lung functions [peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory flow between 25% and 75% of the FVC (FEF))], asthma control [Asthma Control Questionnaire (ACQ-7)], responder analysis (≥ 0.5 unit improvement in ACQ-7), and reduction in asthma exacerbations at Weeks 26 and 52.

Results: A total of 1930 patients were included in this analysis. Medium-dose MF/IND/GLY improved trough FEV versus high-dose MF/IND (Δ 41 mL; 95% CI - 7-90) and high-dose FLU/SAL (Δ 88 mL; 95% CI 39-137) at Week 26 which were sustained until Week 52. Exacerbation rates were 16% lower with medium-dose MF/IND/GLY versus high-dose MF/IND for all (mild, moderate, and severe) exacerbations and 21-30% lower versus high-dose FLU/SAL for all (mild, moderate, and severe), moderate or severe, and severe exacerbations over 52 weeks. Further improvements in other lung functions were observed with medium-dose MF/IND/GLY. No new safety signals were identified.

Conclusion: Medium-dose MF/IND/GLY improved lung function and reduced asthma exacerbations compared to high-dose ICS/LABA and may be an undervalued option in patients at GINA 2022 step 4.

Trial Registration: ClinicalTrials.gov Identifier: NCT02571777.

Citing Articles

2024 Update on Position Statement by Experts from the Polish Society of Allergology and the Polish Respiratory Society on the Evaluation of Efficacy and Effectiveness of Single Inhaler Triple Therapies in Asthma Treatment.

Sliwinski P, Antczak A, Barczyk A, Bialas A, Czajkowska-Malinowska M, Jahnz-Rozyk K Adv Respir Med. 2024; 92(6):452-465.

PMID: 39584852 PMC: 11587102. DOI: 10.3390/arm92060041.

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