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.

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.

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.

Asthma Control in Patients with Severe Eosinophilic Asthma Treated with Reslizumab: Spanish Real-Life Data.

BACKGROUND: Reslizumab is an anti-interleukin 5 monoclonal antibody that has demonstrated to reduce the risk of severe exacerbations and to improve symptoms, lung function, and quality of life in randomized controlled trials that included patients with severe eosinophilic uncontrolled asthma (SEUA) and a history of severe exacerbations. OBJECTIVE: The aim of the present study was to evaluate the effectiveness of add-on reslizumab in a cohort of patients with SEUA under real-life conditions. METHODS: This was a multi-centre, retrospective, real-life study that included subjects with SEUA treated with reslizumab in 44 asthma units throughout Spain. Eligible patients were those who had received at least one dose of reslizumab as part of normal clinical practice. The primary endpoint was complete asthma control at 52 weeks, defined as absence of severe exacerbations, ACT ≥20 and no maintenance oral corticosteroids (OCS). Demographic, clinical, and functional data were collected at baseline (T0), after four to six months (T1); after 12 months (T2) and beyond 12 months of therapy (T3). RESULTS: Treatment with reslizumab achieved complete asthma control in 40% of the 208 included SEUA patients and led to a significant reduction in exacerbations (from 3.0; IQR: 2.0-4.0 at V0 to 0.0; IQR: 0.0-0.0 at V2), maintenance OCS use (from 54.8% (95% CI: 48.0-61.6 at T0 to 18.5% (95% CI: 12.5-24.5 at T2) and a meaningful improvement in symptoms in the entire treated population: ACT increased from 12.8 ± 4.5 at V0 to 20.0 ± 5.1 at V2 (p < 0.001). Most of the improvement achieved at 12 months was obtained at 4-6 months. The retention (continuation) rate of reslizumab was 75% through 2 years (95CI%: 1.9-2.1). Overall, reslizumab showed an adequate safety profile. CONCLUSION: Reslizumab is an effective therapy for SEUA with adequate safety profile in real-life conditions.

[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.

FENOMA Study: Achieving Full Control in Patients with Severe Allergic Asthma.

INTRODUCTION: A Spanish real-world study in patients with severe persistent asthma who achieved asthma control after a one-year treatment with omalizumab highlighted the phenotypic heterogeneity of these patients (FENOMA study). In this subanalysis, we describe the clinical improvement in patients with severe allergic asthma in this study (positive skin test and IgE level 30-1500 IU/mL); n=240. PATIENTS AND METHODS: FENOMA was an observational, multicentre, retrospective study in 345 patients achieving asthma control according to Spanish guidelines (GEMA). Baseline demographic and asthma-related characteristics were collected. Outcomes analyzed were those included in asthma control definition plus changes in background treatments and in blood eosinophil count (%) and exhaled nitric oxide fraction [FeNO]. RESULTS: At baseline, patients were aged 45.4±15.0 years; 67% were women. Median (Q1;Q3) IgE levels were 302.5 (154.0; 553.5) IU/mL. After one-year treatment with omalizumab: 43.3% of patients had daytime symptoms vs 97.7% before treatment and 49.6% stopped taking oral corticosteroids. FEV1 increased a median of 12.0 (4.0; 23.0)%; P <0.0001. The number of non-severe asthma exacerbations decreased a median of -4.0 (-7.0; 2.0); P <0.0001. Median unplanned visits to primary care or specialists and days of school/workplace absenteeism decreased from 4.9 (2.0; 6.0), 1.0 (0.0; 3.0) and 0.0 (0.0; 14.0) to 0.0 (0.0; 1.0), 0.0 (0.0; 0.0) and 0.0 (0.0; 0.0), respectively. Median eosinophil blood count and FeNO decreased from 5.0 (3:0; 8.0)% to 3.0 (2.0; 5.5)% and from 36.0 (23:0; 53.0) ppb to 20.0 (13.0; 34.0) ppb, respectively. CONCLUSION: This study highlights the asthma control achieved by patients with severe allergic asthma treated with omalizumab, with relevant benefits on the burden of the disease both on patients and the healthcare system.

Severe asthma phenotypes in patients controlled with omalizumab: A real-world study.

BACKGROUND: The appropriate identification of asthma phenotypes of responders to omalizumab would optimize the selection of treatment. OBJECTIVE: To describe the most frequent clinical phenotypes in patients with severe asthma responding to omalizumab and their clinical and pulmonary function improvement. METHODS: This was an observational, retrospective, multicenter study. Adult patients with severe asthma, who achieved good control after the first year of treatment with omalizumab were included. Omalizumab was prescribed according to clinical routine practice. Responders were assigned to one pre-established phenotype based on the most predominant one before they had started treatment with omalizumab, all according to the physician's criteria. Data about asthma symptoms, number of non-severe asthma exacerbations, medication intake (inhaled and oral corticosteroids and rescue medication), lung function, high fractional exhaled nitric oxide (FeNO) and peripheral eosinophils counts were recorded. RESULTS: Among the 345 patients included, the main phenotypes were severe asthma with frequent exacerbations (29.9%), early-onset allergic asthma (23.8%), severe steroid-dependent asthma (18.8%), and severe eosinophilic asthma (13.6%). Clinical and respiratory changes observed after first year of treatment with omalizumab included: reduction in asthma symptoms, reduction in the use and dose of corticosteroids and need for rescue therapy, improvement of pulmonary function, reduction in the number of episodes of non-severe asthma exacerbations regardless of the duration of severe disease since the diagnosis. Increased blood levels of peripheral eosinophils and high FeNO levels were found at baseline. CONCLUSION: Several heterogeneous severe asthma phenotypes were observed as good responders to omalizumab.

Estudio prospectivo de 221 neumonías adquiridas en la comunidad seguidas de forma ambulatoria. Etiología y evolución clinicorradiológica / Prospective study of 221 community acquired pneumonias followed up in an outpatient clinic. Etiology and clinical-radiological progression

FUNDAMENTO: Se estudiaron de forma prospectiva las neumonías adquiridas en la comunidad seguidas en una consulta neumológica extrahospitalaria, con objeto de determinar la etiología, las características clinicorradiológicas y su evolución con unas pautas de actuación y tratamiento protocolizadas. PACIENTES Y MÉTODO: Se realizaron protocolos de evaluación clínica, diagnóstico etiológico por serología (en la primera visita y a las tres semanas) y, en los casos necesarios, por fibrobroncoscopia (cepillo microbiológico protegido), así como protocolos de evolución clínica y radiológica (hasta tres revisiones) tras pautas de tratamiento empírico previamente establecidos. RESULTADOS: Se incluyó inicialmente a 240 pacientes, siendo seguidos un total de 221 casos. Obtuvimos el diagnóstico etiológico en 86 pacientes (39 por ciento), siendo el germen más frecuente Coxiella burnetii (12,2 por ciento), seguido de Mycoplasma pneumoniae y Legionella pneumophila. Se diagnosticaron dos casos de Sptreptococcus pneumoniae. La forma de presentación radiológica más frecuente fue la condensación alveolar (86 por ciento). Se emplearon como tratamiento empírico inicial macrólidos (71 por ciento) o cefalosporinas de segunda generación (22 por ciento). La evolución clínica y radiológica fue satisfactoria en la mayoría de los pacientes, siendo necesario el ingreso hospitalario en dos casos (< 1 por ciento del total). CONCLUSIONES: En las neumonías adquiridas en la comunidad en régimen ambulatorio encontramos un elevado número de gérmenes 'atípicos'. En pacientes ambulatorios creemos apropiado el tratamiento empírico con macrólidos o cefalosporinas de segunda generación (AU)