[en] INTRODUCTION: The advent of monoclonals for the treatment of asthma has completely transformed the therapeutic arsenal available in severe asthma, mainly in the high Th2 phenotype, with a plausible improvement in the quality of life of these patients and in the symptomatology associated with the disease. Among these new therapies, Mepolizumab and Omalizumab, were the first to be marketed and approved for severe asthma, and have demonstrated effectiveness in clinical trials and real-life studies. However, there are few studies evaluating their long-term effectiveness and comparing outcomes between these two therapies. In the 2022 Consensus on Severe Asthma in Adults, a multidimensional scale summarised in the acronym EXACTO is included, which measures exacerbations, asthma control using the ACT (Asthma Control Test), continuous systemic corticosteroids and level of airflow obstruction; and divides patients into super-responders, good responders, partial responders and non-responders. OBJECTIVES: The aim of our study will be to evaluate and compare the effectiveness of Mepolizumab and Omalizumab in symptomatology control, systemic glucocorticoid use, exacerbations and lung function, measured by the EXACT index. METHODS: We will carry out a multicentre prospective cohort study, in which 4 hospitals of the Andalusian Health Service (Asthma Units) will participate. The study will include patients of legal age with a diagnosis of severe Th2 phenotype asthma, who meet the criteria for initiation of treatment with Mepolizumab or Omalizumab and who authorise participation. Consecutive sampling will be used to reach a sample size of 95 patients in each treatment group to detect differences in the percentage of patients with good or complete response of magnitude equal to 20% (safety=95%, statistical power=80%). Patients will be followed up at 4 months, 12 months and 24 months, the Exact Index will be recorded for the assessment of disease status as well as the demographic and clinical profile. Descriptive and inferential analysis will be performed. The study will be conducted with the authorisation of the Ethics Committee of the participating hospitals as well as with the informed consent of the patients.

[gl] INTRODUCCIÓN: A chegada dos monoclonales para o tratamento da asma transformou completamente o arsenal terapéutico dispoñible na asma grave, principalmente no fenotipo Th2 alto, cunha melloría plausible na calidade de vida destes pacientes e na sintomatoloxía asociada á enfermidade. Dentro destas novas terapias, temos Mepolizumab e Omalizumab foron os primeiros en comercializarse e aprobarse para asma grave, e qhan demostrado efectividade en ensaios clínicos e estudos en vida real. Con todo, son poucos os estudos que avalían a súa efectividade a longo prazo e que comparen os resultados entre ambos. No Consenso de Asma Grave en adultos de 2022, recòllense unha escala multidimensional resumida no acrònimo EXACTO, que mide exacerbaciones, control da asma mediante o test ACT (Asthma Control Test), corticoterapia sistémica continuos e nivel de obstruciòn ao fluxo aéreo; que divide aos pacientes en superrespondedores, resposta boa, resposta parcial e non resposta. OBXECTIVOS: O obxectivo do noso estudo será avaliar e comparar a efectividade de Mepolizumab e Omalizumab no control de síntomas , uso de glucocorticoides sistémicos, exacerbacións e funciòn pulmonar, medida segundo o índice EXACTO. METODOLOXÍA: estudo de cohortes prospectivo multicéntrico , no que participarán 4 hospitais do Servizo Andaluz de Saúde (Unidades de Asma). Incluiranse pacientes maiores con diagnòstico de asma grave de fenotipo Th2, que cumpran os criterios para iniciar tratamento con Mepolizumab ou Omalizumab e que autoricen a súa pariticpaciòn. Utilizarase unha mostra consecutiva ata acadar un tamaño mostral de 95 pacientes en cada grupo de tratamento que permita detectar diferenzas na porcentaxe de pacientes con resposta boa ou completa de magnitude igual ao 20% (seguridade=95%, potencia estatística=80). %). Realizarase un seguimento dos pacientes aos 4 meses, 12 meses e 24 meses, rexistrarase o Índice Exacto para a avaliaciòn do estado da enfermidade así como do perfil demográfico e clínico. Realizarase unha análise descritiva e inferencial. O estudo realizarase coa autorizaciòn do Comité de Ética dos hospitais participantes e co consentimento informado dos pacientes.