Dupilumab efficacy and safety in Latin American patients with uncontrolled, moderate-to-severe asthma: phase 3 LIBERTY ASTHMA QUEST study.

OBJECTIVE: While advances in asthma care have been made in Latin America, there is still a large unmet need in patients with uncontrolled asthma. This post hoc analysis of the QUEST study assessed safety and efficacy of dupilumab in the subgroup of patients enrolled in Latin American countries with a type 2 inflammatory asthma phenotype (blood eosinophils ≥ 150cells/µL or FeNO ≥25ppb). METHODS: LIBERTY ASTHMA QUEST (NCT02414854) was a phase 3, multinational, randomized, double-blind, placebo-controlled study in patients with uncontrolled, moderate-to-severe asthma. Eligible patients ≥ 12 years of age were randomized in a 2:2:1:1 ratio to receive 52 weeks of add-on subcutaneous dupilumab 200 or 300 mg every 2 weeks or matched-volume placebos. Pre-specified co-primary efficacy endpoints were the annualized rate of severe exacerbations during the treatment period and the change from baseline in pre-bronchodilator FEV1 at treatment week 12. Asthma control, changes in asthma biomarker levels, and dupilumab safety were also evaluated. RESULTS: 530 (27.9% of the overall QUEST population; dupilumab: 353, placebo: 177) Latin-American patients were recruited; 420 (79.2%) had a type 2 inflammatory asthma phenotype. Dupilumab vs placebo reduced the annualized rate of severe exacerbations by 52.7% (P < 0.001) and increased pre-bronchodilator FEV1 at week 12 by 0.15 L (P < 0.001), in the type 2 population. Safety was consistent with the known dupilumab safety profile. CONCLUSIONS: Consistent with the results in the overall population, dupilumab reduced the risk of severe asthma exacerbations and improved lung function in Latin American patients with uncontrolled, moderate-to-severe asthma and a type 2 phenotype.

Over-prescription of short-acting ß2-agonists is associated with poor asthma outcomes: results from the Latin American cohort of the SABINA III study.

OBJECTIVE: Short-acting ß2-agonist (SABA) over-reliance is associated with poor asthma outcomes. As part of the SABA Use IN Asthma (SABINA) III study, we assessed SABA prescriptions and clinical outcomes in patients from six Latin American countries. METHODS: In this cross-sectional study, data on disease characteristics/asthma treatments were collected using electronic case report forms. Patients (aged ≥12 years) were classified by investigator-defined asthma severity (guided by the 2017 Global Initiative for Asthma) and practice type (primary/specialist care). Multivariable regression models analyzed the associations between SABA prescriptions and clinical outcomes. RESULTS: Data from 1096 patients (mean age, 52.0 years) were analyzed. Most patients were female (70%), had moderate-to-severe asthma (79.4%), and were treated by specialists (87.6%). Asthma was partly controlled/uncontrolled in 61.5% of patients; 47.4% experienced ≥1 severe exacerbation in the previous 12 months. Overall, 39.8% of patients were prescribed ≥3 SABA canisters in the preceding 12 months (considered over-prescription). SABA canisters were purchased over the counter (OTC) by 17.2% of patients, of whom 38.8% purchased ≥3 canisters in the 12 months prior. Of patients who purchased SABA OTC, 73.5% were prescribed ≥3 SABA canisters. Higher SABA prescriptions (vs. 1 - 2 canisters) were associated with an increased incidence rate of severe exacerbations (ranging from 1.31 to 3.08) and lower odds ratios of having at least partly controlled asthma (ranging from 0.63 to 0.15). CONCLUSIONS: SABA over-prescription was common in Latin America, highlighting the need for urgent collaboration between healthcare providers and policymakers to align clinical practices with the latest evidence-based recommendations to address this public health concern.

Short-acting ß2-agonist prescriptions are associated with poor clinical outcomes of asthma: the multi-country, cross-sectional SABINA III study.

BACKGROUND: To gain a global perspective on short-acting ß2-agonist (SABA) prescriptions and associated asthma-related clinical outcomes in patients with asthma, we assessed primary health data across 24 countries in five continents. METHODS: SABINA III was a cross-sectional study that employed electronic case report forms at a study visit (in primary or specialist care) to record prescribed medication(s), over-the-counter (OTC) SABA purchases and clinical outcomes in asthma patients (≥12 years old) during the past 12 months. In patients with ≥1 SABA prescriptions, associations of SABA with asthma symptom control and severe exacerbations were analysed using multivariable regression models. RESULTS: Of 8351 patients recruited (n=6872, specialists; n=1440, primary care), 76.5% had moderate-to-severe asthma and 45.4% experienced ≥1 severe exacerbations in the past 12 months. 38% of patients were prescribed ≥3 SABA canisters; 18.0% purchased OTC SABA, of whom 76.8% also received SABA prescriptions. Prescriptions of 3-5, 6-9, 10-12 and ≥13 SABA canisters (versus 1-2) were associated with increasingly lower odds of controlled or partly controlled asthma (adjusted OR 0.64 (95% CI 0.53-0.78), 0.49 (95% CI 0.39-0.61), 0.42 (95% CI 0.34-0.51) and 0.33 (95% CI 0.25-0.45), respectively; n=4597) and higher severe exacerbation rates (adjusted incidence rate ratio 1.40 (95% CI 1.24-1.58), 1.52 (95% CI 1.33-1.74), 1.78 (95% CI 1.57-2.02) and 1.92 (95% CI 1.61-2.29), respectively; n=4612). CONCLUSIONS: This study indicates an association between high SABA prescriptions and poor clinical outcomes across a broad range of countries, healthcare settings and asthma severities, providing support for initiatives to improve asthma morbidity by reducing SABA overreliance.