IDENTIFICATION AND CHARACTERIZATION OF PATIENTS WITH MODERATE-TO-SEVERE ASTHMA ELIGIBLE FOR TRIPLE THERAPY IN ITALY: EVIDENCE FROM AN ADMINISTRATIVE HEALTHCARE DATABASE
Author(s)
Letizia Dondi, BS, Leonardo Dondi, BS, Irene Dell'Anno, PhD, Nicola Ambrosio, PhD, Giulia Ronconi, PharmD, Alice Addesi, MSc, Immacolata Esposito, PhD, Nello Martini, PharmD, Carlo Piccinni, PhD.
Fondazione Ricerca e Salute (ReS) - Research and Health Foundation, Roma, Italy.
Fondazione Ricerca e Salute (ReS) - Research and Health Foundation, Roma, Italy.
OBJECTIVES: Recent evidence and GINA guidelines have expanded the role of triple therapy (TT: ICS/LABA/LAMA) in moderate-to-severe asthma, supporting its use as both a step-up and treatment simplification strategy. This study aimed to identify and characterize patients currently receiving or potentially eligible for TT in Italian real-world clinical practice.
METHODS: This retrospective observational study used the Fondazione ReS administrative healthcare database (5.1 million inhabitants in 2022). Individuals aged ≥12 with ≥5 years of continuous observability before the index year (2022) were included. Asthma patients were identified through specific diagnostic/exemption codes (definite asthma) or recurrent ICS/LABA use consistent with moderate-to-severe asthma (probable asthma). Patients were classified into mutually exclusive cohorts: Cohort A, receiving multiple-inhaler TT; Cohort B, receiving continuous ICS/LABA therapy with medium/high-dose ICS with evidence of uncontrolled asthma, defined as ≥1 hospital-managed exacerbation or ≥2 OCS-treated exacerbations; and Cohort C, receiving continuous ICS/LABA therapy with medium/high dose ICS with one OCS-treated exacerbation representing a disease worsening despite maintenance treatment.
RESULTS: In 2022, 72,430 patients with definite or probable moderate-to-severe asthma were identified. Among them, 7,189 met the criteria for current or potential TT use, corresponding to a prevalence of 177.5 per 100,000 inhabitants aged ≥12 years. Patients were classified into Cohort A (n=2,209), Cohort B (n=2,255), and Cohort C (n=2,725). Females predominated across all cohorts (60-63%). Cohort A was the oldest (mean age: 65 years) and showed the highest comorbidity burden (30.6% ≥3 comorbidities). Cohort B had an intermediate profile (mean age: 55 years; 19.6% ≥3 comorbidities), whereas Cohort C was the youngest (mean age: 52 years) and healthiest, with 47.9% presenting no comorbidities.
CONCLUSIONS: The study identified a cohort of Italian patients with moderate-to-severe asthma in multiple-inhaler TT or who remained uncontrolled despite maintenance treatment with medium/high-dose ICS and LABA. These patients were eligible for escalation or simplification to fixed TT.
METHODS: This retrospective observational study used the Fondazione ReS administrative healthcare database (5.1 million inhabitants in 2022). Individuals aged ≥12 with ≥5 years of continuous observability before the index year (2022) were included. Asthma patients were identified through specific diagnostic/exemption codes (definite asthma) or recurrent ICS/LABA use consistent with moderate-to-severe asthma (probable asthma). Patients were classified into mutually exclusive cohorts: Cohort A, receiving multiple-inhaler TT; Cohort B, receiving continuous ICS/LABA therapy with medium/high-dose ICS with evidence of uncontrolled asthma, defined as ≥1 hospital-managed exacerbation or ≥2 OCS-treated exacerbations; and Cohort C, receiving continuous ICS/LABA therapy with medium/high dose ICS with one OCS-treated exacerbation representing a disease worsening despite maintenance treatment.
RESULTS: In 2022, 72,430 patients with definite or probable moderate-to-severe asthma were identified. Among them, 7,189 met the criteria for current or potential TT use, corresponding to a prevalence of 177.5 per 100,000 inhabitants aged ≥12 years. Patients were classified into Cohort A (n=2,209), Cohort B (n=2,255), and Cohort C (n=2,725). Females predominated across all cohorts (60-63%). Cohort A was the oldest (mean age: 65 years) and showed the highest comorbidity burden (30.6% ≥3 comorbidities). Cohort B had an intermediate profile (mean age: 55 years; 19.6% ≥3 comorbidities), whereas Cohort C was the youngest (mean age: 52 years) and healthiest, with 47.9% presenting no comorbidities.
CONCLUSIONS: The study identified a cohort of Italian patients with moderate-to-severe asthma in multiple-inhaler TT or who remained uncontrolled despite maintenance treatment with medium/high-dose ICS and LABA. These patients were eligible for escalation or simplification to fixed TT.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EPH95
Topic
Epidemiology & Public Health, Real World Data & Information Systems, Study Approaches
Topic Subcategory
Public Health
Disease
Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)