Benralizumab in severe eosinophilic asthma: A real-world, single-center, observational study from Mexico.

INTRODUCTION: Urbanization has increased the prevalence of asthma in lower- and middle-income countries. Severe eosinophilic asthma (SEA), a subtype of asthma, can be refractory to standard therapy. Biologics such as benralizumab target interleukin-5 and have demonstrated effectiveness in managing SEA. There exists no real-world evidence on the effectiveness of benralizumab in Mexico. Therefore, this study presents data on the role of benralizumab in managing SEA in Mexican patients. OBJECTIVE: The effectiveness of benralizumab on the quality of life (QoL), asthma control, lung function, symptoms of asthma, and benralizumab's safety profile were assessed. METHODS: The study sample comprised 10 patients with SEA treated with a subcutaneous (SC) administration of benralizumab 30 mg once in 4 weeks for the first three doses followed by a dose every 8 weeks for 2 years. Laboratory tests, resting spirometry, and skin prick tests were conducted. Levels of fractional exhaled nitric oxide (FeNO) were evaluated, when possible, with the intent to phenotype asthma, as T2 high or non-T2, before starting benralizumab therapy. The Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ), and Asthma Control Test (ACT) were administered to evaluate the effectiveness of benralizumab on asthma control and QoL. RESULTS: All patients showed significant symptom control, QoL, and lung function over 2 years. Mild adverse effects, such as headache and arthralgia, were observed. CONCLUSION: Benralizumab appears to be a promising agent in controlling SEA. This study has focused on measuring tangible outcomes, such as a reduction in symptoms, a reduction in exacerbation, and an improvement in QoL. Thus, benralizumab may constitute an important addition to the arsenal of medications against SEA.

[Control de asma grave predominantemente eosinofílica con el uso de anti IL-5].

Background: Asthma is a chronic inflammatory disease of the airways, caused by inflammatory cells and mediators, associated with smooth muscle dysfunction, causing variable airflow obstruction. With high, low and mixed type 2 immunoinflammatory mechanisms (endotypes). Severe asthma is that which requires step 4 or 5 of treatment (GINA 2023). The TH2 High phenotype, non-allergic with eosinophilia and FENO, is the second most common. It affects 300 million people around the world. Objetive: Describe asthma biomarkers after the use of antiinterleukin 5, Benralizumab, in adults with severe asthma. Methods: Case report, descriptive study. Patients with severe eosinophilic asthma and chronic polyposis rhinosinusitis under treatment with anti-IL5 were included, evaluating inflammatory biomarkers. Results: Serum eosinophils, FENO, ACT, spirometry, and exacerbations were measured in 8 patients at baseline and 6 months after treatment. The FEV1-FVC was 51% with improvement up to 95% later. 5 patients had FENO > 45 ppm subsequently only 3 continued to be inflamed. Eosinophilia 150 cells and subsequently only 1 patient persisted with eosinophilia 200 cells. Initial ACT < 19 in 7 patients Final ACT >19 in 7 patients. Exacerbations 8 patients with 2 or more exacerba- tions subsequently only 1 patient presented exacerbation. Conclusion: The use of anti-interleukin 5 (benralizumab) does reduce inflammatory markers, improves control and number of exacerbations in the short term. Monoclonal antibodies (Anti IL-5), if they improve inflammatory biomarkers, if clinical characteristics and inflammatory biomarkers are taken into account, it favors adequate asthma control.

Antecedentes: El asma es una enfermedad inflamatoria crónica de vías respiratorias, provocada por células y mediadores inflamatorios, asociado a disfunción del músculo liso, provocando obstrucción variable del flujo aereo. Con mecanismos inmunoinflamatorios tipo 2 altos, bajos y mixtos (endotipos). Asma grave es aquella que requiere paso 4 o 5 de tratamiento (GINA 2023). El fenotipo TH2 Alto, no alergico con eosinofilia y FENO, es el segundo más común. Afecta a 300 millones de personas alrededor del mundo. Objetivo: Describir biomarcadores de asma, posterior al uso de antiinterleucina 5, Benralizumab, en adultos con asma grave. Métodos: Reporte de casos, estudio descriptivo. Se incluyeron pacientes con asma grave eosinofilica y rinosinusitis crónica poliposica en tratamiento con an- ti-IL5, evaluando biomarcadores inflamatorios Resultados: En 8 pacientes se midieron eosinófilos séricos, FENO, ACT, espirometría y exacerbaciones al inicio y 6 meses después del tratamiento. El FEV1-FVC fue 51% con mejoría hasta 95% después. 5 pacientes tenían FENO >45 ppm posteriormente solo 3 continuron inflamados. Eosinofilia 150 células y posterior- mente solo 1 paciente persistió con eosinofilia 200 células. ACT inicial < 19 en 7 pacientes ACT final > 19 en 7 pacientes. Exacerbaciones 8 pacientes con 2 o más exacerbaciones posteriormente solo 1 paciente presentó exacerbación. Conclusión: El uso de antiinterleucina 5 (Benralizumab) si disminuye marcadores inflamatorios, mejora el control y número de exacerbaciones a corto plazo. Los anticuerpos monoclonales (Anti IL-5), si mejoran biomarcadores inflamatorios si se toman en cuenta caracteristicas clínicas y biomarcadores inflamatorios favorece adecuado control de asma.

[Practical guide for the follow-up and management of patients with severe asthma treated with biologics]. / Guía práctica de seguimiento y manejo del paciente con asma grave tratado con biológicos.

The management of severe uncontrolled asthma with biologics is an area of extreme difficulty given the scarcity of information regarding their starting criteria, the variables to be evaluated to determine the efficacy and safety of their management, the cut-off points to determine the timing to change or add another biological and the process to decrease or withdraw steroids. This review incorporates the latest information and makes a proposal based on it.

El manejo del asma grave descontrolada con biológicos es un área de extrema dificultad, dada la escasez de información respecto a los criterios de inicio de los mismos, las variables a evaluar para determinar la eficacia y seguridad de su manejo, los puntos de corte para determinar el momento oportuno para cambiar o agregar otro biológico y el proceso para disminuir o retirar los esteroides. Esta revisión incorpora la información más reciente y realiza una propuesta con base en ella.

Guía práctica de seguimiento y manejo del paciente con asma grave tratado con biológicos / Practical guide for the follow-up and management of patients with severe asthma treated with biologics

El manejo del asma grave descontrolada con biológicos es un área de extrema dificultad, dada la escasez de información respecto a los criterios de inicio de los mismos, las variables a evaluar para determinar la eficacia y seguridad de su manejo, los puntos de corte para determinar el momento oportuno para cambiar o agregar otro biológico y el proceso para disminuir o retirar los esteroides. Esta revisión incorpora la información más reciente y realiza una propuesta con base en ella.

The management of severe uncontrolled asthma with biologics is an area of extreme difficulty given the scarcity of information regarding their starting criteria, the variables to be evaluated to determine the efficacy and safety of their management, the cut-off points to determine the timing to change or add another biological and the process to decrease or withdraw steroids. This review incorporates the latest information and makes a proposal based on it