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

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.