Real-life cost-effectiveness of benralizumab in patients with severe asthma.

BACKGROUND: Availability of clinically effective and cost-effective treatments for severe asthma would be beneficial to patients and national healthcare systems. The aim of this study was to evaluate clinical outcomes and healthcare expenditure after incorporating benralizumab into the standard treatment of refractory eosinophilic asthma. METHODS: This was a cross-sectional multicentre study of consecutive patients with refractory eosinophilic asthma who received treatment with benralizumab during at least 12 months. Patient follow-up was performed in specialised severe asthma units. The main effectiveness parameters measured were: the avoidance of one asthma exacerbation, a 3-point increase in the asthma control test (ACT) score, and the difference in utility scores (health-related quality of life) between a 1-year baseline treatment and 1-year benralizumab treatment. The health economic evaluation included direct costs and incremental cost-effectiveness ratios (ICERs). RESULTS: After 1 year of treatment with benralizumab, patients with refractory eosinophilic asthma showed an improvement in all the effectiveness parameters analysed: improvement of asthma control and lung function, and decrease in the number of exacerbations, oral corticosteroid (both as corticosteroid courses and maintenance therapy), and inhaled corticosteroid use. The total annual cost per patient for the baseline and benralizumab treatment periods were €11,544 and €14,043, respectively, reflecting an increase in costs due to the price of the biological agent but a decrease in costs for the remaining parameters. The ICER was €602 per avoided exacerbation and €983.86 for every 3-point increase in the ACT score. CONCLUSIONS: All the pharmacoeconomic parameters analysed show that treatment with benralizumab is a cost-effective option as an add-on therapy in patients with refractory eosinophilic asthma.

Real-life experience with benralizumab during 6 months.

BACKGROUND: Benralizumab is a monoclonal antibody that binds to the human interleukin-5 (IL-5) receptor (IL-5R), thereby preventing IL-5 from binding to its receptor and inhibiting differentiation and maturation of eosinophils in the bone marrow. Because of its recent marketing approval, sufficient real-life evidence is lacking to confirm the efficacy and safety data from clinical trials. The purpose of this study was to evaluate the efficacy and safety of benralizumab for the treatment of severe refractory eosinophilic asthma in a real-world cohort of patients. METHODS: This was a cross-sectional multicentre study of consecutive patients with severe refractory eosinophilic asthma who received treatment with benralizumab during at least 6 months. Patient follow-up was performed in specialised severe asthma units. RESULTS: A total of 42 patients were enrolled and treated with benralizumab. Asthma control, as measured by the asthma control test (ACT), improved in all patients both at 3 months of treatment compared with baseline (13.9 ± 4 vs 20.1 ± 3.7, p < 0.001) and at 6 months of treatment compared with the results obtained at 3 months (20.1 ± 3.7 vs 21 ± 2.7, p = 0.037). Similarly, the number of emergency department visits decreased both at 3 months compared with baseline (1 [IR:0.7] vs 0 [IR:0.75], p < 0.001) and at 6 months compared with the results at 3 months (0 [IR:0.75] vs 0 [IR:0], p = 0.012). Reductions in the number of oral corticosteroid cycles, percentage of corticosteroid-dependent patients, and mean daily dose of oral or inhaled corticosteroid were also evidenced. Finally, mean lung function improvement was 291 mL (p < 0.001), and FEV1% improved both at 3 months compared with baseline (64.4 ± 9.3 vs 73.1 ± 9.1, p < 0.001) and at 6 months compared to 3 months (73.1 ± 9.1 vs 76.1 ± 12, p = 0.002). Side effects were mild and did not lead to treatment discontinuation. CONCLUSIONS: This study confirms the efficacy and safety of benralizumab in a real-life setting with improved asthma control and lung function, and a reduced oral and inhaled corticosteroid use as well as fewer emergency department visits. In addition to a rapid initial improvement, it appears that patients continue to improve during the first 6 months of treatment.

Factors associated with bronchiectasis in patients with uncontrolled asthma; the NOPES score: a study in 398 patients.

BACKGROUND: Some studies have reported a high prevalence of bronchiectasis in patients with uncontrolled asthma, but the factors associated with this condition are unknown. The objective of this study was to determine the prevalence of bronchiectasis in uncontrolled moderate-to-severe asthma and to identify risk factors and their correlation with bronchiectasis in these patients. METHODS: This is a prospective study of data from consecutive patients with uncontrolled moderate-to-severe asthma. Diagnosis of bronchiectasis was based on high-resolution computed tomography. A prognostic score was developed using a logistic regression model, which was used to determine the factors associated with bronchiectasis. RESULTS: A total of 398 patients (60% with severe asthma) were included. The prevalence of bronchiectasis was 28.4%. The presence of bronchiectasis was associated with a higher frequency of chronic expectoration (OR, 2.95; 95% CI, 1.49-5.84; p = 0.002), greater severity of asthma (OR, 2.43; 95% CI, 1.29-4.57; p = 0.006), at least one previous episode of pneumonia (OR, 2.42; 95% CI, 1.03-5.69; p = 0.044), and lower levels of FeNO (OR, 0.98; 95% CI, 0.97-0.99; p = 0.016). The NOPES score was developed on the basis of these variables (FeNO[cut off point 20.5 ppb], Pneumonia, Expectoration and asthma Severity), and it ranges from 0 to 4 points, where 0 means "no risk" and 4 corresponds to "high risk". The NOPES score yielded an AUC-ROC of 70% for the diagnosis of bronchiectasis, with a specificity of 95%. CONCLUSIONS: Almost a third of the patients with uncontrolled moderate-to-severe asthma had bronchiectasis. Bronchiectasis was related to the severity of asthma, the presence of chronic expectoration, a previous history of pneumonia, and lower levels of FeNO. The NOPES score is an easy-to-use scoring system with a high prognostic value for bronchiectasis in patients with uncontrolled moderate-to-severe asthma.

Monitorización del tratamiento antibiótico nebulizado en bronquiectasias no fibrosis quística colonizadas por Pseudomonas aeruginosa. Estudio multicéntrico / Monitoring nebulized antibiotic treatment in non-cystic fibrosis bronchiectasis colonized by Pseudomonas aeruginosa: A multi-centerstudy

OBJETIVOS: 1- Valorar la adherencia al tratamiento nebulizado con colistimetato de sodio-Promixín® con dispositivo Ineb® en pacientes con bronquiectasias (BQ) no fibrosis quística (FQ) colonizadas por Pseudomonas aeruginosa; 2- Identificar un perfil de paciente incumplidor. MÉTODO: Estudio multicéntrico, observacional, prospectivo, de corte transversal, de una cohorte de adultos tratados al menos durante 6 meses con colistimetato de sodio (Promixin®) administrado con el nebulizador Ineb®. Se obtuvieron los registros del tratamiento nebulizado (plataforma informática Insight®), datos de función pulmonar, cultivos de esputo y número de agudizaciones antes y después del tratamiento. Se analizó la adherencia global, el manejo del nebulizador y la adherencia real. Se define a los pacientes con mala adherencia terapéutica como aquellos con una adherencia global o real ≤80%. RESULTADOS: La muestra inicial fue de 126 pacientes, considerándose no válidos para su análisis 20 de ellos, siendo seleccionados 106 pacientes con BQ no FQ, 47 de causa postinfecciosa (44,3%), 13 EPOC (12,3%), 12 discinesia ciliar (11,3%), 17 otras causas(16%) y 17 idiopáticas (16%). La edad media fue de 64,0 ± 14,6 años, 57 varones (53,8%) y 49 mujeres (46,2%), 61 procedentes de hospitales terciarios (57,5%) y 45 de comarcales (42,5%). La adherencia global fue del 86,7 ± 19,3% y en el 73,6% de los casos ≥80%. El 96,6 ± 7,8% de los pacientes manejaron adecuadamente el nebulizador, con unos tiempos de nebulización de 6,3 ± 3,4 minutos. La adherencia real fue del 84,4 ± 20,2% y en el 75,5% de los casos ≥80%. No hubo diferencias en cuanto al sexo, edad, función pulmonar, causa de las BQ no FQ y exacerbaciones previas para ninguna de estas variables. CONCLUSIÓN: En nuestra población el manejo del nebulizador y la adherencia, global y real, es muy buena. El escaso número de pacientes no adherentes no nos ha permitido definir el perfil del incumplidor

OBJECTIVE: 1) Assess adherence to nebulized treatment with colistimethate sodium-Promixin® using an Ineb® nebulizer in patients with bronchiectasis (BQ) but without cystic fibrosis (CF) colonized by Pseudomonas aeruginosa; 2) Identify a noncompliant patient profile. METHOD: A multi-center, observational, prospective, transversal study, with a cohort of adults treated for at least six months with colistimethate sodium (Promixin®) administered with an Ineb® nebulizer. Registers of nebulized treatment were obtained (Insight® IT platform), pulmonary lung function, sputum culture and number of exacerbations prior to and after the treatment. Global adherence was analyzed, as well as handling the nebulizer and real adherence. Patients with poor therapeutic adherence were defined as those with a global or real adherence of ≤80%. RESULTS: The initial sample included 126 patients, 20 of which were considered not valid for the analysis; 106 patients with BQ non-CF, 47 were post-infectious causes(44.3%), 13 COPD (12.3%), 12 ciliary dyskinesia(11.3%), 17 other causes (16%) and 17 idiopathic (16%). The mean age was 64.0 ± 14.6 years; 57 males (53.8%) and 49 females (46.2%), 61 were from tertiary hospitals (57.5%) and 45 from local hospitals (42.5%). Global adherence was 86.7 ± 19.3% and in 73.6% of the cases ≥80%. 96.6 ± 7.8% of the patients adequately handled the nebulizer, with nebulization times of 6.3 ± 3.4 minutes. Real adherence was 84.4 ± 20.2% and in 75.5% of the cases ≥80%. No differences were seen in terms of sex, age, pulmonary function, cause of BQ non-CF and prior exacerbations for none of these variables. CONCLUSION: In our population, handling the nebulizer and adherence, both global and real, is very good. The limited number of patients who failed to adhere has hindered our defining a non-compliant profile