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. 2025 Jun 30;11(3):00869-2024.
doi: 10.1183/23120541.00869-2024. eCollection 2025 May.

Treatment choice for adult patients with moderate-to-severe asthma: the TAILOR study

Affiliations

Treatment choice for adult patients with moderate-to-severe asthma: the TAILOR study

Daniel Jeannetot et al. ERJ Open Res. .

Abstract

Background: In patients with uncontrolled asthma treated with medium dose inhaled corticosteroid/long-acting β2-agonist (ICS/LABA), the Global Initiative for Asthma (GINA) recommends to increase to high-dose ICS/LABA or to start therapy consisting of medium-dose ICS/LABA+LAMA (long-acting muscarinic antagonist). Adding LAMA on top of high-dose ICS/LABA is not recommended for Step 4 asthma patients, yet it is used in the real world. Patient characteristics influencing treatment step-up are unknown. The objectives of the present study were to identify determinants of step-up option (high-dose ICS/LABA, medium-dose ICS/LABA+LAMA, high-dose ICS/LABA+LAMA) in patients with moderate to severe asthma.

Methods: A retrospective cohort study using three primary care databases (IPCI, HSD, CPRD GOLD) and one prescription database (Aarhus) included asthma patients with step-up after ≥3 months use of medium-dose ICS/LABA, from January 2010 to April 2020. Characteristics of patients were described, and determinants of choice for medium-dose ICS/LABA+LAMA or high dose ICS/LABA were investigated.

Results: 492 639 adults with asthma and ≥1 year of database history were identified and 25 558 were eligible for analysis. 6126 patients stepped-up to medium-dose ICS/LABA+LAMA and 18 947 patients stepped-up to high-dose ICS/LABA. Determinants for step-up to medium-dose ICS/LABA+LAMA were higher age and presence of COPD whereas history of atopy lowered this choice. Other covariates were differentially associated with specific treatment step-up depending on the databases.

Conclusion: In uncontrolled asthma patients on medium-dose ICS/LABA, treatment step-up with add-on LAMA was more likely than step-up to high-dose ICS/LABA in older patients, current smokers, with a history of asthma exacerbations and concomitant diagnosis of COPD.

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Conflict of interest statement

Conflict of interest: F. Lapi and E. Marcona have provided consultations in protocol preparation for epidemiological studies and data analyses for AstraZeneca, GSK and Chiesi. M. Van Der Deijl is an employee of Chiesi. G. Brusselle reports fees for advisory boards and speaker's fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, Merck Sharp & Dohme (MSD) and Sanofi Regeneron. All other authors have nothing to disclose.

Figures

FIGURE 1
FIGURE 1
Prevalence of underlying comorbidity at time of treatment. Database locations: Aarhus (Denmark), CPRD (United Kingdom), HSD (Italy), IPCI (Netherlands). y-axis differs per comorbidity. GERD: gastro-oesophageal reflux disease; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist.
FIGURE 2
FIGURE 2
Odds ratio (OR) for factors of step-up treatment to medium-dose ICS/LABA+LAMA instead of high-dose ICS/LABA: meta-analysis. Each graph indicates the odds ratio for patients to be stepped up to medium-dose ICS/LABA+LAMA if they have one of these factors. Reference category for visits to general practitioner (GP) practice was number of visits to GP practice in first quarter. Reference category for number of SABA prescriptions in previous year was – Low: 0 in HSD, 0–1 in IPCI and Aarhus, 0–6 in CPRD GOLD; Medium: 1 in HSD, 2–4 in IPCI and Aarhus, 7–10 in CPRD GOLD; High: ≥2 in HSD, ≥5 in IPCI and Aarhus, ≥11 in CPRD GOLD. GERD: gastro-oesophageal reflux disease; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist; SABA: short-acting β2-agonist; N SABA: number of SABA prescriptions.
FIGURE 3
FIGURE 3
Drivers of step-up treatment to medium-dose ICS/LABA+LAMA instead of high-dose ICS/LABA (continued): meta-analysis. Each graph indicates the odds ratio (OR) for patients to be stepped up to medium-dose ICS/LABA+LAMA if they have one of these factors. Reference category for Adult and Late onset asthma was Childhood onset asthma, and for CCI categories CCI=1. CCI: Charlson Comorbidity Index; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist.
FIGURE 4
FIGURE 4
Drivers of step-up treatment to medium-dose ICS/LABA+LAMA instead of high-dose ICS/LABA (continued): meta-analysis. Each graph indicates the odds ratio (OR) for patients to be stepped up to medium-dose ICS/LABA+LAMA if they have one of these factors. N exacerbations: number of exacerbation events. Reference category for exacerbations was No exacerbations in previous year. Reference category for smoking was Never-smoker. ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist.

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