Effectiveness of Switching to Benralizumab in Severe Refractory Eosinophilic Asthma.

Purpose: Benralizumab is a monoclonal antibody that targets the α subunit of the IL-5 receptor. Clinical trials have demonstrated the efficacy of this agent with respect to lung function and symptom control in patients with refractory eosinophilic asthma. However, few studies have evaluated the efficacy of benralizumab after switching previous treatment with other monoclonal antibodies. Patients and Methods: We performed a multicenter retrospective study under conditions of daily clinical practice. The study population comprised consecutively included patients with severe refractory eosinophilic asthma whose initial treatment with omalizumab or mepolizumab was switched to benralizumab. Patients were evaluated at 4 and 12 months after starting treatment with benralizumab. We analyzed asthma control, number of severe exacerbations, corticosteroid cycles, visits to the emergency department, and hospital admissions, as well as lung function. Similarly, we evaluated the response to treatment according to previously established criteria. Results: We evaluated 40 patients who switched from omalizumab (n=16) or mepolizumab (n=24) to benralizumab. The reasons for switching were lack of response in 30 cases, adverse effects in 9, and patient request in 1. Switching was followed by a significant decrease in the number of exacerbations, visits to the emergency department, and corticosteroid cycles, as well as improved ACT both at 4 and 12 months. However, no significant improvement in lung function was observed. Asthma control (including complete response and control) was achieved in 55% of patients (n=22) at 12 months. Specifically, a complete response was achieved in 30% of patients at 12 months (66.7% switching from omalizumab and 33.3% from mepolizumab). Conclusion: Patients diagnosed with severe refractory eosinophilic asthma who experience a partial response with omalizumab or mepolizumab could benefit from switching to benralizumab. This approach can reduce the number of exacerbations, visits to the emergency department, and corticosteroid cycles and improve control of asthma.

Influence of climatic variables on chronic obstructive pulmonary disease patient attendance to a pulmonary rehabilitation program.

PURPOSE: Implementing adherence to pulmonary rehabilitation (PR) programs is key to obtaining the best results. The objective of our study was to evaluate the influence of weather conditions (humidity, temperature, and precipitation) on attendance to a PR program in chronic obstructive pulmonary disease (COPD) patients. METHODS: This prospective observational study, carried out in Seville (Spain), included COPD patients who participated in a 36-session outpatient mixed (strength and endurance) training program for 12 weeks. The program included educational sessions as well. The attendance at the program scheduled sessions during 1 year was evaluated in relation to the meteorological conditions of relative humidity in percentage (%), temperature in degree centigrade (°C), and precipitation in millimeters (mm) according to the data from the State Meteorological Agency (AEMET) and the meteorological center of La Rinconada. RESULTS: A total of 81 COPD patients who underwent 2903 sessions were analyzed. The annual average attendance of the program was 78.6%. No differences were found in the attendance to the program depending on the climatic conditions evaluated throughout the year. CONCLUSIONS: In a specific geographical area such as Seville, meteorological conditions are not a determining factor of attendance to the PR program for COPD patients.

Preference for Easyhaler® Over Previous Dry Powder Inhalers in Asthma Patients: Results of the DPI PREFER Observational Study.

OBJECTIVE: To study patient preference for and satisfaction with the Easyhaler® device and to assess ease of training and use of the inhaler in patients previously treated with a variety of dry powder inhalers (DPIs). METHODS: We designed a non-interventional, cross-sectional, single-visit observational study of adult patients with persistent asthma referred to specialized care who had previously been treated with DPI inhalers for at least 3 months. Once clinical baseline data had been checked, patients filled in questionnaires on asthma control (GINA 2019), Feeling of Satisfaction with the Inhaler (FSI-10), and adherence (TAI and Morisky-Green questionnaires). Thereafter, all patients were trained in the use of Easyhaler. We assessed ease of use and satisfaction (FSI-10) with Easyhaler, as well as inhaler device preferences. RESULTS: We recruited 502 patients (mean age, 50.2 ± 16.2 y; 63.1% female), of whom 485 were evaluable. In response to the main objective of the study, we compared the values of the self-completed adapted FSI-10, to measure satisfaction with the inhaler. A significantly higher score in each item of the questionnaire was recorded for Easyhaler. Overall, 38% of patients showed exclusive preference for Easyhaler (compared with 15% for the previous device) or were evenly matched in 46% of cases. CONCLUSION: In the present study, Easyhaler achieved better patient ratings in terms of preference and satisfaction than previously used DPI devices. In order to improve asthma adherence strategies, patient preferences and device choice should be taken into account.

Economic Impact and Clinical Outcomes of Omalizumab Add-On Therapy for Patients with Severe Persistent Asthma: A Real-World Study.

BACKGROUND: Omalizumab is a fully humanized monoclonal antibody indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma. AIMS: The aim of this study was to evaluate social, healthcare expenditure and clinical outcomes changes after incorporating omalizumab into standard treatment in the control of severe asthma. METHODS: In this multicentre retrospective study, a total of 220 patients were included from 15 respiratory medicine departments in the regions of Andalusia and Extremadura (Spain). Effectiveness was calculated as a 3-point increase in the Asthma Control Test (ACT) and a reduction in the annual number of exacerbations. The economic evaluation included both direct and indirect costs. Incremental cost-effectiveness ratio (ICER) was calculated. Results from the year before and the year after incorporation of omalizumab were compared. RESULTS: After adding omalizumab, improvement of lung function, asthma and rhinitis according to patient perception, as well as the number of exacerbations and asthma control measured by the ACT score were observed. Globally, both healthcare resources and pharmacological costs decreased after omalizumab treatment, excluding omalizumab cost. When only direct costs were considered, the ICER was €1712 (95% CI 1487-1995) per avoided exacerbation and €3859 (95% CI 3327-4418) for every 3-point increase in the ACT score. When both direct and indirect costs were considered, the ICER was €1607 (95% CI 1385-1885) for every avoided exacerbation and €3555 (95% CI 3012-4125) for every 3-point increase. CONCLUSIONS: Omalizumab was shown to be an effective add-on therapy for patients with persistent severe asthma and allowed reducing key drivers of asthma-related costs.

Perfil de pacientes que abandonan un programa de rehabilitación respiratoria / Patient Profile of Drop-Outs From a Pulmonary Rehabilitation Program

Introducción: Aunque los beneficios de los programas de rehabilitación respiratoria (RR) en pacientes EPOC han sido demostrados, la adherencia es baja, relacionándose con peores resultados. Objetivo: Identificar las causas de abandono de un programa de RR para EPOC y las características de los pacientes con mala adherencia, haciendo especial énfasis en características funcionales y clínicas. Método: Estudio prospectivo en 83 EPOC desde febrero a noviembre de 2015. Se realizó un programa mixto (fuerza y resistencia) ambulatorio de 36 sesiones. Se facilitó la accesibilidad con ambulancias. Los pacientes fueron divididos en adherentes (acudieron al menos al 70% del programa) o no adherentes (al menos a una sesión). Resultados: Se evaluaron 83 pacientes, de los que 26 fueron excluidos. Un 15,7% rehusó participar. La tasa de abandono fue del 38,5%. Las principales causas fueron tener baja motivación para acudir al gimnasio y problemas de trasporte. El grupo que abandonó el programa presentó una menor capacidad vital forzada (abandonan 58,9% vs. completan 67,8%; p = 0,03), peores resultados en el test de esfuerzo submáximo (abandonan 6,2 min vs. completan 9,2 min; p = 0,02), en W totales (abandonan 42,6 vs completan 56,5; p = 0,03) y en VO2, tanto en ml/min/kg (abandonan 11,4 vs completan 13,6; p = 0,03) como en ml/min (abandonan 839 vs completan 1.020; p = 0,04). Este grupo también presentó mayor uso de esteroides orales (abandonan 23,8% vs completan 2,9%; p = 0,01). Conclusiones: Más de 1/3 de los pacientes abandonan los programas. Las causas principales son relativas a la motivación y el transporte. El perfil de paciente que abandona presenta peores pruebas funcionales, más exacerbaciones, uso de esteroides y tabaquismo

Introduction: While the benefits of pulmonary rehabilitation programs (PR) in COPD have been demonstrated, poor adherence, related with worse clinical outcomes, is common. Objective: The purpose of this study was to examine causes for drop-out during a 12-week multidisciplinary pulmonary rehabilitation program and to investigate the characteristics of patients with poor adherence, with special emphasis on functional and clinical characteristics. Method: A prospective study was performed between February and November 2015 in 83 COPD patients enrolled in an outpatient program of 36 strength +resistance training sessions. Ambulances were provided to facilitate access to the clinic. Patients were divided into: adherent (A) (attended at least 70% of the program) or non-adherent (NA) (at least one session). Results: A total of 83 patients were evaluated and 26 excluded; 15.7% refused to participate. The drop-out rate was 38.5%. The main causes were low motivation and transport problems. Lower forced vital capacity (NA, 58.9% vs A, 67.8%; P = .03), worse results on submaximal exercise test (NA, 6.2 minutes vs A, 9.2 minutes; P = .02), in total distance walked (NA, 42.6 vs A, 56.5; P = .03) and VO2 in ml/min/kg (NA, 11.4 vs A, 13.6; P = .03) and in ml/min (NA, 839 vs A, 1020; P = .04) were found in the non-adherent group. This group also showed higher use of oral steroids (NA, 23.8% vs A, 2.9%; P = .01). Conclusions: More than 1/3 of patients leave programs. The main causes are related to motivation and transport. The patients who dropout are those with worse functional tests, more exacerbations, steroids and smoking habit

Patient Profile of Drop-Outs From a Pulmonary Rehabilitation Program. / Perfil de pacientes que abandonan un programa de rehabilitación respiratoria.

INTRODUCTION: While the benefits of pulmonary rehabilitation programs (PR) in COPD have been demonstrated, poor adherence, related with worse clinical outcomes, is common. OBJECTIVE: The purpose of this study was to examine causes for drop-out during a 12-week multidisciplinary pulmonary rehabilitation program and to investigate the characteristics of patients with poor adherence, with special emphasis on functional and clinical characteristics. METHOD: A prospective study was performed between February and November 2015in 83 COPD patients enrolled in an outpatient program of 36 strength +resistance training sessions. Ambulances were provided to facilitate access to the clinic. Patients were divided into: adherent (A) (attended at least 70% of the program) or non-adherent (NA) (at least one session). RESULTS: A total of 83 patients were evaluated and 26 excluded; 15.7% refused to participate. The drop-out rate was 38.5%. The main causes were low motivation and transport problems. Lower forced vital capacity (NA, 58.9% vs A, 67.8%; P=.03), worse results on submaximal exercise test (NA, 6.2minutes vs A, 9.2minutes; P=.02), in total distance walked (NA, 42.6 vs A, 56.5; P=.03) and VO2 in ml/min/kg (NA, 11.4 vs A, 13.6; P=.03) and in ml/min (NA, 839 vs A, 1020; P=.04) were found in the non-adherent group. This group also showed higher use of oral steroids (NA, 23.8% vs A, 2.9%; P=.01). CONCLUSIONS: More than 1/3 of patients leave programs. The main causes are related to motivation and transport. The patients who dropout are those with worse functional tests, more exacerbations, steroids and smoking habit.

Anxiety, depression and tobacco abstinence. / Ansiedad, depresión y deshabituación tabáquica.

There is evidence of the relationship between mental illness and smoking and increased risk of depressive episodes after quitting smoking, even with specific treatments for abstinence. OBJECTIVE: To assess the influence of a cessation program on the emotional state of patients by measuring levels of anxiety / depression and differences depending on the presence of psychiatric history. METHOD: A prospective observational study of patients taking part in a combined program (pharmacological and cognitive-behavioral) for giving up smoking. Anxiety (A) and depression (D) were measured using the HADS questionnaire at baseline, first and third month of abstinence. RESULTS: Anxiety and depression showed significant and progressive improvement during treatment (A: baseline 9.2 ± 4.5, 5.9 ± 3.6 1 month, 3 months 4.5 ± 3.1, p.

Existe evidencia de la relación entre patología mental y tabaquismo y del mayor riesgo de sufrir un episodio depresivo al dejar de fumar, incluso con tratamientos específicos para la abstinencia. Objetivo: valorar la influencia de un programa de abandono del tabaco en el estado emocional de los pacientes mediante la medición de los niveles de ansiedad/depresión y las posibles diferencias en función de la presencia de antecedentes psiquiátricos. Método: estudio de cohortes observacional y prospectivo de pacientes que acudieron a dejar de fumar mediante programa combinado (farmacológico y cognitivo-conductual). Se midió ansiedad (A) y depresión (D) utilizando el cuestionario HADS al inicio, primer y tercer mes de abstinencia. Resultados: la ansiedad y la depresión presentaron mejoría significativa y progresiva a lo largo del tratamiento (A: basal 9,2±4,6; 1 mes 5,9±3,6; 3 meses 4,5±3,1; p.

Ansiedad, depresión y deshabituación tabáquica / Anxiety, Depression and Tobacco Abstinence

Existe evidencia de la relación entre patología mental y tabaquismo y del mayor riesgo de sufrir un episodio depresivo al dejar de fumar, incluso con tratamientos específicos para la abstinencia. Objetivo: valorar la influencia de un programa de abandono del tabaco en el estado emocional de los pacientes mediante la medición de los niveles de ansiedad/depresión y las posibles diferencias en función de la presencia de antecedentes psiquiátricos. Método: estudio de cohortes observacional y prospectivo de pacientes que acudieron a dejar de fumar mediante programa combinado (farmacológico y cognitivo-conductual). Se midió ansiedad (A) y depresión (D) utilizando el cuestionario HADS al inicio, primer y tercer mes de abstinencia. Resultados: la ansiedad y la depresión presentaron mejoría significativa y progresiva a lo largo del tratamiento (A: basal 9,2±4,6; 1 mes 5,9±3,6; 3 meses 4,5±3,1; p<0,05 / D: basal 5,5±4,1; 1 mes 3±3; 3 meses 2,3±2,1; p<0,05), en la población psiquiátrica (A: basal 11,3±4,5; 1 mes 7,1±3,7; 3 meses 5,3±3,5; p<0,05 / D: basal 7,4±4,8; 1 mes 4,2±3,6; 3 meses 3±2,9; p<0,05), e independientemente del tratamiento. Tasa de abstinencia: 58,5%, no se vio afectada por los niveles basales de ansiedad y depresión. No se detectaron efectos secundarios neuropsiquiátricos relevantes. Conclusiones: los niveles de ansiedad y depresión evolucionan favorablemente durante el programa, alcanzándose buenos resultados, independientemente de la presencia de patología psiquiátrica

There is evidence of the relationship between mental illness and smoking and increased risk of depressive episodes after quitting smoking, even with specific treatments for abstinence. Objective: To assess the influence of a cessation program on the emotional state of patients by measuring levels of anxiety / depression and differences depending on the presence of psychiatric history. Method: A prospective observational study of patients taking part in a combined program (pharmacological and cognitive-behavioral) for giving up smoking. Anxiety (A) and depression (D) was measured using the HADS questionnaire at baseline, first and third month of abstinence. Results: Anxiety and depression showed significant and progressive improvement during treatment (A: baseline 9.2 ± 4.5, 5.9 ± 3.6 1 month, 3 months 4.5 ± 3.1, p <0 05 / D: baseline 5.5 ± 4.1; 1 month 3 ± 3; 3 months 2.3 ± 2.1, p <0.05), in psychiatry population (A: baseline 11.3 ± 4 , 5; 1 month 7.1 ± 3.7, 5.3 ± 3.5 3 months, p <0.05 / D: baseline 7.4 ± 4.8, 4.2 ± 3.6 one month; 3 months 3 ± 2.9, p <0.05), regardless of treatment. Abstinence rate: 58.5%, unaffected by baseline levels of anxiety and depression. No significant neuropsychiatric side effects were detected. Conclusions: Anxiety and depression levels evolved favourably during the program, achieving good results regardless of the presence of psychiatric pathology