One-year follow-up of asthmatic patients newly initiated on treatment with medium- or high-dose long-acting beta2-agonist/inhaled corticosteroid (LABA/ICS) in UK primary care settings1
- Approximately 39% of patients with asthma remain uncontrolled, despite current treatment with inhaled therapies1
What was already known?
- Global Initiative for Asthma (GINA) 2020 strategy recommends low- to high-dose LABA/ICS as preferred controller treatments for patients with moderate or moderate to severe asthma2
- Many patients with asthma remain uncontrolled on medium- or high-dose LABA/ICS and have higher rates of morbidity, mortality and healthcare resource utilisation compared with patients whose asthma is controlled1,3,4
- For patients whose asthma remains uncontrolled on LABA/ICS, GINA recommends an increase in the dose of ICS or addition of one or more controllers such as a long-acting muscarinic antagonist (LAMA) or leukotriene receptor antagonist (LTRA), before stepping up to biologics and/or low-dose maintenance oral corticosteroid (OCS)2
Why was this study conducted?1
- To understand the level of control in moderate to severe asthma patients initiated on medium- or high-dose LABA/ICS
- To evaluate how physicians choose step-up options for medium- or high-dose LABA/ICS in real-world clinical practice
- To examine asthma control in patients who were adherent to their LABA/ICS therapy
- Retrospective cohort study
Objectives and endpoints1
- Asthma control in the follow-up period, assessed using a composite outcome including moderate or severe exacerbations, treatment step-up, and short-acting beta2-agonist use ≥450 µg Defined Daily Dose per year; patients with any occurrence of one or more of these events were identified as uncontrolled
- An exacerbation was considered moderate if managed in primary care, i.e. asthma-related general practitioner (GP) visit and OCS burst; severe exacerbations were defined as asthma-related hospitalisation or accident and emergency visit
- Treatment step-up was either addition of one or more asthma controllers, including LAMA, LTRA, theophylline, or maintenance OCS in patients of both LABA/ICS cohorts, and increase in ICS dose only in the medium-dose LABA/ICS cohort
- Adherence to treatment, defined as Medication Possession Ratio (MPR) of ≥80%
- Changes in asthma treatments post medium- or high-dose LABA/ICS implemented by GPs, percentage of patients who stepped up or stepped down, and medications that patients stepped up/down to were also examined during the follow-up period. Healthcare resource utilisation in medium- and high-dose LABA/ICS cohorts was assessed in terms of asthma-specific prescriptions and rates of specialist referral and hospitalisations
- Patients newly initiated on medium- or high-dose LABA/ICS identified in Clinical Practice Research Datalink with linked Hospital Episode Statistics data between 01/01/2006 and 28/02/2016
- A total of 29,229 and 16,575 patients initiated medium- and high-dose LABA/ICS, respectively
- Patients could be included in both cohorts at different time periods
What are the results of the study and why are they relevant?1
- 35.1% (medium-dose cohort) and 45.7% (high-dose cohort) of asthma patients on newly initiated LABA/ICS remain uncontrolled in the UK
- 63.8% (medium-dose cohort) and 70.0% (high-dose cohort) of patients with asthma who were adherent to LABA/ICS (MPR ≥80%) remain uncontrolled
- LTRA and LAMA were the preferred add-on medication to LABA/ICS among patients with uncontrolled asthma
- 41.1% of patients with uncontrolled asthma in medium-dose and 31.2% in high-dose LABA/ICS cohort had no treatment step-up
- Healthcare resource utilisation was high in patients with uncontrolled asthma, regardless of the LABA/ICS dose
- 37.8% and 49.1% of patients on medium- and high-dose LABA/ICS respectively were considered to be adherent to their treatment regimen (MPR ≥80%)
Implications for clinical practice1
A significant proportion of patients newly initiated on medium- or high-dose LABA/ICS therapy remain uncontrolled and at risk of exacerbation even when adherent to these treatments, highlighting the need for timely assessment of asthma control and stepping-up of therapy.
Indication: ENERZAIR BREEZHALER is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.5
GINA, Global Initiative for Asthma; GP, general practitioner; ICS, inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; LTRA, leukotriene receptor antagonist; MPR, Medication Possession Ratio; OCS, oral corticosteroid.
- Buhl R et al. Respir Med 2019;162:105859 [Epub ahead of print].
- Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020. Available at: https://ginasthma.org/wp-content/uploads/2020/04/GINA-2020-full-report_-.... Date accessed: December 2020.
- Schatz M et al. J Allergy Clin Immunol Pract 2014;2(5):570–574.
- Lang D. Allergy Asthma Proc 2015;36(6):418–424.
- ENERZAIR BREEZHALER Summary of Product Characteristics.