Spanish Consensus on Remission in Asthma (REMAS).

The concept of "remission" in asthma has been around for a long time and it has been a controversial topic. Despite the attempts of some studies to characterize this entity, the discussion continues. In the case of asthma there is still no clear definition, either in terms of its meaning or the parameters that should be included or whether it should be divided into clinical or complete remission. To help defining these controversial concepts, SEPAR has advocated the multidisciplinary working group REMAS (REMission in ASthma). Following the Delphi methodology and with the involvement of more than 120 specialists in asthma management, this group has arrived at a consensus on the definitions of remission in asthma and establishing the criteria and characteristics that will be of use in future studies evaluating the efficacy or effectiveness of treatments.

[Unmet Needs in Severe Allergic Asthma]. / Necesidades no cubiertas en asma alérgica grave.

Severe asthma affects 3%-10% of the world's population, according to estimates by the Global Initiative for ASTHMA (GINA). Allergic asthma is one of the most common phenotypes of severe asthma and it is characterized by allergen-induced type 2 inflammation in which immunoglobulin E (IgE) is a key mediator, making it an important therapeutic target. The introduction of targeted biological therapies or treatments has entered the management for severe asthma in the era of precision medicine, and the goal of treatment is clinical remission of the disease. There is a significant percentage of patients with severe allergic asthma who do not respond to treatments and whose symptoms are not controlled. In this paper, a group of experts in the management of severe allergic asthma reviewed and evaluated the most relevant evidence regarding the pathophysiology and phenotypes of severe allergic asthma, the role of IgE in allergic inflammation, allergen identification, techniques, biomarkers and diagnostic challenges, available treatments and strategies for disease management, with a special focus on biological treatments. From this review, recommendations were developed and validated through a Delphi consensus process with the aim of offering improvements in the management of severe allergic asthma to the professionals involved and identifying the unmet needs in the management of this pathology.

Treatment Patterns of Monoclonal Antibodies in Patients With Severe Uncontrolled Asthma Treated by Pulmonologists in Spain.

Introduction and objectives: The use of monoclonal antibody (mAb)-based therapies is becoming the new standard of care for severe uncontrolled asthma (SUA). Even though patients may qualify for one or more of these targeted treatments, based on different clinical criteria, a global vision of mAb prescription management in a large sample of hospitals is not well characterised in Spain.The objective was to give a global vision of mAb prescription management in a large sample of hospitals in Spain. Materials and methods: We used an aggregate data survey method to interview pulmonology specialists in a large sample of Spanish centres (90). The following treatment-related information was obtained on patients treated with mAbs: specific mAbs prescribed, treatment interruption, switch and restart and the reasons for these treatment changes. Results: mAb prescription was more frequent in females (13.3% females vs 7.4% males; p < 0.001). There were no differences in prevalence by hospital complexity level. In contrast, there were differences by geographical area. Omalizumab was the most prescribed mAb (6.2%), followed by mepolizumab (2.9%). Discontinuation of Omalizumab (due to a lack of effectivity) and switches from this mAb to mepolizumab were more frequent. Very few restarts to the first treatment were observed after a switch from ≥2 mAbs. Conclusions: Omalizumab appeared as the most prescribed mAb in SUA but was also the most withdrawn; a specific and objective characterisation of patients with SUA, along with asthma phenotyping, and together with further evaluation of safety and effectiveness profiles, will lead to future progress in the management of SUA with mAbs.

Introducción y objetivos: El uso de terapias basadas en anticuerpos monoclonales (mAb) se está convirtiendo en el nuevo estándar de atención para el asma grave no controlada (AGNC). A pesar de que los pacientes pueden optar a uno o varios de estos tratamientos dirigidos, con base en diferentes criterios clínicos, en España no se ha caracterizado bien una visión global de la gestión de la prescripción de mAb en una gran muestra de hospitales.El objetivo fue dar una visión global de la gestión de la prescripción de mAB en una amplia muestra de hospitales en España. Materiales y métodos: Se utilizó un método basado en una encuesta de datos agregados para entrevistar a especialistas en Neumología en una amplia muestra de centros españoles (90). Se obtuvo la siguiente información relacionada con el tratamiento de los casos tratados con mAbs: mAbs específicos prescritos, interrupción del tratamiento, cambio y reinicio, y las razones de estos cambios de tratamiento en consultas de Neumología. Resultados: La prescripción de mAB fue más frecuente en mujeres (13,3% mujeres vs. 7,4% hombres; p < 0,001). No hubo diferencias de prevalencia por nivel hospitalario. En cambio, hubo diferencias por área geográfica. Omalizumab fue el mAb más prescrito (6,2%), seguido de mepolizumab (2,9%). La interrupción y los cambios (debido a la falta de efectividad) también fueron más frecuentes para omalizumab. Conclusiones: Omalizumab fue el mAb más prescrito en el manejo de AGNC, pero también fue el mAB que presentó más retiradas; una caracterización específica y objetiva de los pacientes con AGNC, mediante fenotipificación de asma, junto con una evaluación adicional de los perfiles de seguridad y efectividad, conducirá a nuevos avances en el manejo del AGNC con mABs.

[A Study of the Prevalence of Asthma in the General Population in Spain]. / Estudio de prevalencia de asma en población general en España.

Introduction: Asthma is a disease with high prevalence, which affects all age groups and generates high health and social care costs. Studies carried out in a number of populations show great variability in its prevalence, even in geographically close populations, with data suggesting a relevant influence of socio-economic factors. At present, we do not have reliable data on the prevalence of this disease in the adult population of Spain. The objectives of this study are to estimate the prevalence of asthma in the Spanish population for those aged 18-79, to describe the variability between autonomous communities, to estimate the prevalence of under and overdiagnosis, to analyse the prevalence of uncontrolled asthma and steroid-dependent asthma, to evaluate the health care cost, to identify the most frequent phenotypes and to establish a starting point to evaluate the temporal trend with subsequent studies. Methods: A cross-sectional, two-stage study will be carried out, including patients from 50 catchment areas. The study will be carried out in 3 phases: 1) screening and confirmation in the clinical history, in which patients with a previously correctly established diagnosis of asthma will be identified; 2) diagnosis of asthma to evaluate patients without a confirmed or excluded diagnosis; 3) characterization of asthma, where the characteristics of the asthmatic patients will be analysed, identifying the most frequent phenotypes. Discussion: It seems necessary and feasible to carry out an epidemiological study of asthma in Spain to identify the prevalence of asthma, to optimize healthcare planning, to characterize the most frequent phenotypes of the disease, and to evaluate inaccurate diagnoses.

Evaluation of the Diagnostic Accuracy of Non-Specific Bronchial Provocation Tests in the Diagnosis of Asthma: A Randomized Cross-Over Study

Introduction: The role of bronchial provocation tests in the diagnosis of asthma remains to be fully explored. We aimed to evaluate methacholine and mannitol challenge testing, and explore the factors associated with this broncoprovocation response.Methods: Observational, cross-over, randomized trial evaluating adult cases with suspected asthma, naïve to treatment, with normal pre-bronchodilator spirometry, and negative bronchodilator test. Patients were randomized to start with methacholine or mannitol. The diagnosis of bronchial asthma was confirmed if there was a good functional and clinical response to one month with twice daily formoterol/budesonide 9/320. The diagnostic profile and the concordance were calculated. Factors associated with a positive provocation test were entered into a multivariate binomial logistic regression analysis, and classification trees were created for both tests.Results: The study included 108 cases (50.0% diagnosed with asthma and 51.9% cases starting with methacholine). The percentage of cases positive to methacholine and mannitol were 30.6% and 25.0% respectively. Kappa values were 0.40 (p<0.001). The diagnostic profile for methacholine was sensitivity 59.3% and specificity 98.1%, while for mannitol it was sensitivity 48.1% and specificity 98.1%. Variables associated with a positive methacholine response included sex, atopy, FEV1, FEV1/FVC and FENO, whereas they were FEV1/FVC and FENO for mannitol. A FENO value>26ppb, FEV1≤103.3% and female sex correctly classified 78.7% of methacholine responders. FENO value>26ppb was enough to correctly classify 81.5% of mannitol responders.Conclusions: Our study confirms the diagnostic profile of methacholine and mannitol challenge tests and describes the variable associated to their positivity with new proposed cutoff values. (AU)

Evaluation of the Diagnostic Accuracy of Non-Specific Bronchial Provocation Tests in the Diagnosis of Asthma: A Randomized Cross-Over Study.

INTRODUCTION: The role of bronchial provocation tests in the diagnosis of asthma remains to be fully explored. We aimed to evaluate methacholine and mannitol challenge testing, and explore the factors associated with this broncoprovocation response. METHODS: Observational, cross-over, randomized trial evaluating adult cases with suspected asthma, naïve to treatment, with normal pre-bronchodilator spirometry, and negative bronchodilator test. Patients were randomized to start with methacholine or mannitol. The diagnosis of bronchial asthma was confirmed if there was a good functional and clinical response to one month with twice daily formoterol/budesonide 9/320. The diagnostic profile and the concordance were calculated. Factors associated with a positive provocation test were entered into a multivariate binomial logistic regression analysis, and classification trees were created for both tests. RESULTS: The study included 108 cases (50.0% diagnosed with asthma and 51.9% cases starting with methacholine). The percentage of cases positive to methacholine and mannitol were 30.6% and 25.0% respectively. Kappa values were 0.40 (p<0.001). The diagnostic profile for methacholine was sensitivity 59.3% and specificity 98.1%, while for mannitol it was sensitivity 48.1% and specificity 98.1%. Variables associated with a positive methacholine response included sex, atopy, FEV1, FEV1/FVC and FENO, whereas they were FEV1/FVC and FENO for mannitol. A FENO value>26ppb, FEV1≤103.3% and female sex correctly classified 78.7% of methacholine responders. FENO value>26ppb was enough to correctly classify 81.5% of mannitol responders. CONCLUSIONS: Our study confirms the diagnostic profile of methacholine and mannitol challenge tests and describes the variable associated to their positivity with new proposed cutoff values.

Consensus document on asthma and smoking of the Regional Asthma Forum of SEPAR. / Documento de consenso sobre asma y tabaquismo del Foro Autonómico de Asma de la SEPAR.

The prevalence of active smoking in adults with asthma is similar in the total population. Smoking is associated with worse clinical control of the disease, a rapid reduction of lung function and a variable response to corticoids. Tobacco consumption negatively affects the quality of life of asthmatic patients as well as increasing the number of medical visits and hospital admissions due to exacerbations. Moreover, smoking entails a higher risk of developing lung cancer, cardiovascular comorbidities and death in asthmatic patients. Nevertheless, current asthma guidelines do not include specific recommendations on the management of smoking asthmatic patients and the treatment of the smoking habit in this subpopulation. For this reason, a narrative review of the literature was carried out for consensus using a nominal group methodology developed throughout 2019 to extract practical recommendations that would allow the diagnosis and treatment of asthma in smokers, as well as the treatment of smoking in asthmatics, to be improved. The conclusions and recommendations were validated at the SEPAR national congress of the same year. Among the most relevant, the need to address smoking in people with asthma through health advice, pharmacological treatment and behavioral therapy was emphasized, as this is a factor that negatively impacts the symptoms, prognosis and response to asthma treatment. In smokers with suspected asthma, the presence of emphysema and the differential diagnosis of other diseases should be evaluated and the impact of smoking on the result of diagnostic tests should be considered. It is also concluded that smoking reduces the response to treatment with inhaled corticosteroids, which is why combined therapy with bronchodilators is recommended.

La prevalencia de tabaquismo activo en adultos con asma es similar a la de la población general. El tabaquismo se asocia con un peor control clínico de la enfermedad, una disminución acelerada de la función pulmonar y una respuesta irregular a la terapia con glucocorticoides. El consumo de tabaco impacta negativamente en la calidad de vida de los pacientes asmáticos y provoca un incremento en el número de visitas y de hospitalizaciones por exacerbaciones. Además, el tabaquismo aumenta el riesgo de cáncer de pulmón, comorbilidades cardiovasculares y muerte en pacientes asmáticos. A pesar de todo ello, las guías actuales del manejo del asma no incluyen recomendaciones específicas para el manejo de los pacientes asmáticos fumadores. Por este motivo, se procedió a una revisión narrativa de la literatura para un consenso mediante metodología de grupo nominal desarrollada a lo largo del año 2019 para extraer recomendaciones prácticas que permitieran mejorar el diagnóstico y el tratamiento del asma en fumadores, así como el tratamiento del tabaquismo en asmáticos. Las conclusiones y recomendaciones fueron validadas en el congreso nacional de la SEPAR del mismo año. Entre las más relevantes, se incidió en la necesidad de abordar el tabaquismo en las personas con asma mediante consejo sanitario, tratamiento farmacológico y terapia conductual, al ser un factor que impacta negativamente en la sintomatología, el pronóstico y la respuesta al tratamiento del asma. En el fumador con sospecha de asma, se debe evaluar la presencia de enfisema y el diagnóstico diferencial de otras enfermedades y considerar el impacto del tabaquismo en el resultado de las pruebas diagnósticas. También se concluye que el hábito tabáquico reduce la respuesta al tratamiento con corticoides inhalados, por lo que se recomienda terapia combinada con broncodilatadores.

Documento de consenso de expertos para el control del asma en personas mayores / Expert consensus recommendations for the management of asthma in older adults

El asma constituye un problema de salud pública presente en pacientes de cualquier edad, aunque continúa existiendo cierta tendencia a asumir de forma errónea que dicha entidad resulta casi siempre exclusiva de la infancia y de gente joven. Los estudios epidemiológicos señalan que, a partir de la sexta década de la vida, la prevalencia de esta enfermedad en países como España alcanza el 6-10%, con mayor predominio entre las mujeres de 64 a 75 años. Asimismo, dos tercios de las muertes debidas al asma acontecen en esta etapa de la vida, llegando a ocasionar un número de ingresos sustancial, estancias hospitalarias más prolongadas y, desde el punto de vista del financiador, unos costes económicos directos notables. En la actualidad el asma en las personas mayores (65 años o más) constituye un tema de enorme preocupación, cuya realidad se encuentra infravalorada e infratratada, por lo que resulta del todo necesario establecer unas recomendaciones adecuadas para el diagnóstico y tratamiento de la enfermedad en esta población de edad. Con este objetivo nació este consenso que recoge la evidencia disponible más actualizada. Las recomendaciones/conclusiones que se proponen son el resultado de un consenso de tipo nominal desarrollado a lo largo del año 2019 y que han sido validadas por los panelistas en sucesivas rondas de votación. (AU)

Asthma is a public health problem in patients of any age, although there is still a tendency to erroneously assume that it is almost always confined to children and young people. Epidemiological studies indicate that, from the sixth decade of life, the prevalence of this disease in countries such as Spain reaches 6-10%, with a higher prevalence among women aged 64 to 75 years. In addition, two-thirds of asthma deaths occur at this stage of life, resulting in a substantial number of hospital admissions, longer hospital stays and, from a finance point of view, significant direct economic costs. Asthma in older adults (65 years or older) is now a matter of great concern, the reality of which is underestimated and undertreated. It is therefore essential to establish appropriate recommendations for the diagnosis and treatment of asthma in the aging population. This consensus, which brings together the latest evidence available, was conceived with this objective. The proposed recommendations/conclusions are the result of a nominal consensus developed throughout 2019 and validated by panellists in successive rounds of voting. (AU)

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.

El asma en las personas mayores también existe / Asthma Exists in Older People too

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[Translated article] Asthma Exists in Older People too / El asma en las personas mayores también existe

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[Consensus document for severe asthma in adults. 2022 update]. / Documento de consenso de asma grave en adultos. Actualización 2022.

Severe asthma is a heterogeneous syndrome with several clinical variants and often represents a complex disease requiring a specialized and multidisciplinary approach, as well as the use of multiple drugs. The prevalence of severe asthma varies from one country to another, and it is estimated that 50% of these patients present a poor control of their disease. For the best management of the patient, it is necessary a correct diagnosis, an adequate follow-up and undoubtedly to offer the best available treatment, including biologic treatments with monoclonal antibodies. With this objective, this consensus process was born, which began in its first version in 2018, whose goal is to offer the patient the best possible management of their disease in order to minimize their symptomatology. For this 2020 consensus update, a literature review was conducted by the authors. Subsequently, through a two-round interactive Delphi process, a broad panel of asthma experts from SEPAR and the regional pulmonology societies proposed the recommendations and conclusions contained in this document.

Monoclonal antibody treatment for severe uncontrolled asthma in Spain: analytical map.

BACKGROUND: Monoclonal antibodies (mABs) have become available to treat more efficiently patients with severe uncontrolled asthma (SUA). However, the use of mABs is lower than expected given the prevalence of SUA, with significant disparities in the use of these treatments. OBJECTIVE: To evaluate the proportion of patients with SUA treated with mABs in Spain, and to analyze some of the factors that could determine these prescription patterns. METHODS: An analysis was performed on the data provided from the Hospitals National Health System (NHS) 2018 catalogue where Chest Diseases Department and a Hospital Pharmacy were available. Random sampling was performed to determine the sample size, stratifying proportionally by geographic area and hospital level. Characteristics of the participating sites, as well as the prescribing of mABs were collected, which included geographic area, hospital levels, prescribing medical specialities, types of clinics, and mABs prescribed. RESULTS: Data from 90 hospitals were analyzed (Response rate 64.3%). Level 4 hospitals, the Canary Islands geographical area, and the presence of a high complexity Asthma Healthcare Unit (ACU) were associated with a higher probability that the SUA was treated with mABs. CONCLUSION: The map of the prescribing of mABs for SUA in Spain shows a significant variation by geographic area, hospital level, type of clinic, and the accreditation level of the ACUs. At the current time, there appears to be significant under-prescribing of these treatments.

Expert consensus recommendations for the management of asthma in older adults. / Documento de consenso de expertos para el control del asma en personas mayores.

Asthma is a public health problem in patients of any age, although there is still a tendency to erroneously assume that it is almost always confined to children and young people. Epidemiological studies indicate that, from the sixth decade of life, the prevalence of this disease in countries such as Spain reaches 6-10%, with a higher prevalence among women aged 64 to 75 years. In addition, two-thirds of asthma deaths occur at this stage of life, resulting in a substantial number of hospital admissions, longer hospital stays and, from a finance point of view, significant direct economic costs. Asthma in older adults (65 years or older) is now a matter of great concern, the reality of which is underestimated and undertreated. It is therefore essential to establish appropriate recommendations for the diagnosis and treatment of asthma in the aging population. This consensus, which brings together the latest evidence available, was conceived with this objective. The proposed recommendations/conclusions are the result of a nominal consensus developed throughout 2019 and validated by panellists in successive rounds of voting.

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.

[Referral Criteria for Asthma: An Updated Consensus]. / Criterios de derivación en asma: Actualización documento de consenso.

Asthma is one of the most prevalent chronic diseases in Spain. In 2019, the Spanish Society of Allergology and Clinical Immunology (SEAIC), the Spanish Society of Primary Care Physicians (SEMERGEN), the Spanish Society of Family and Community Medicine (semFYC), the Spanish Society of General and Family Physicians (SEMG) and the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) drafted a document laying down the criteria for referral and action guidelines in the diagnosis, control and monitoring of the asthmatic patient to facilitate ongoing care and improved attention in every setting. The new circumstances derived from the Covid-19 pandemic have demanded that some of the recommendations of the previous edition be updated and adapted to the new healthcare situation.

[Asthma 2020 Nursing Consensus Document]. / Documento de consenso de enfermería en asma 2020.

Asthma is a chronic respiratory disease which presents with a risk of exacerbations. Good patient management and continuous monitoring are crucial for good disease control, and pharmacological and non-pharmacological interventions are essential for proper treatment. Nurses specialised in asthma can contribute to the correct management of asthmatic patients. They play a key role in diagnostic tests, administration of medication, and patient follow-up and education. This consensus arose from the need to address an aspect of asthma management that does not appear in the specific recommendations of current guidelines. This document highlights and updates the role of specialized nurses in the care and management of asthma patients, offering conclusions and practical recommendations with the aim of improving their contribution to the treatment of this disease. Proposed recommendations appear as the result of a nominal consensus which was developed during 2019, and validated at the beginning of 2020.