Clinical benefits of tezepelumab in a real-world cohort of patients with severe uncontrolled asthma in Castilla-La Mancha, Spain

Introduction: Tezepelumab is an anti-thymic stromal lymphopoietin monoclonal antibody approved for the treatment of severe uncontrolled asthma regardless of inflammatory phenotype. Although its efficacy has been demonstrated in clinical trials, there is a growing need to evaluate its effectiveness in real-world clinical practice in Spain. The aim of this study was to evaluate the clinical impact of tezepelumab in patients with severe asthma treated in 5 hospitals in Castilla-La Mancha, Spain. Material and methods: This was a retrospective multicenter observational study. Adult patients with severe asthma treated with tezepelumab were included between January 2023 and April 2025. Clinical, functional, and laboratory parameters were evaluated between the 6-month baseline period (before treatment initiation) and the follow-up visit. Exacerbations, asthma control test (ACT), lung function (forced expiratory volume in 1 second FEV1), use of oral corticosteroids, and eosinophil count were analyzed. Results: A total of 48 patients were included (mean age 52.8 years; 70.8% women). The mean number of exacerbations decreased significantly from 2.06 to 0.22 per patient (p<0.001), ACT scores increased from 12.8 to 19.2 points (p<0.001), FEV1 improved by 170 mL (p=0.01), and chronic use of oral corticosteroids fell from 14.5% to 4.2%. No significant differences were observed in inflammatory phenotype or prior history of biological treatment, except for a greater reduction in oral corticosteroid cycles in biologic-naïve patients. Clinical remission was achieved in 25% of patients. Conclusions: Tezepelumab was shown to be effective in real-world clinical practice, achieving a significant improvement in severe asthma control and lung function, while reducing exacerbations and oral corticosteroid use. Introducción: Tezepelumab es un anticuerpo monoclonal anti–linfopoyetina estromal tímica aprobado para el tratamiento del asma grave no controlada, independientemente del fenotipo inflamatorio. Aunque su eficacia se ha demostrado en ensayos clínicos, es necesario evaluar su efectividad en la práctica clínica real en España. Este estudio evaluó el impacto clínico de tezepelumab en pacientes con asma grave atendidos en cinco hospitales de Castilla-La Mancha. Material y métodos: Estudio observacional retrospectivo y multicéntrico. Se incluyeron pacientes adultos con asma grave tratados con tezepelumab entre enero de 2023 y abril de 2025. Se compararon parámetros clínicos, funcionales y analíticos entre los 6 meses previos al inicio del tratamiento y la visita de seguimiento. Se analizaron exacerbaciones, test de control del asma (ACT), función pulmonar (volumen espiratorio forzado en el primer segundo FEV1), uso de corticosteroides orales y recuento de eosinófilos. Resultados: Se incluyeron 48 pacientes (edad media 52,8 años; 70,8% mujeres). Las exacerbaciones disminuyeron de 2,06 a 0,22 por paciente (p<0,001). Las puntuaciones del ACT aumentaron de 12,8 a 19,2 puntos (p<0,001), el FEV1 mejoró 170 mL (p=0,01) y el uso crónico de corticosteroides orales se redujo del 14,5% al 4,2%. No hubo diferencias relevantes según fenotipo inflamatorio o tratamiento biológico previo, salvo mayor reducción de ciclos de corticosteroides en pacientes nave al tratamiento biológico. El 25% alcanzó remisión clínica. Conclusiones: Tezepelumab resultó efectivo en la práctica clínica real, mejorando el control del asma grave y la función pulmonar, y reduciendo exacerbaciones y el uso de corticosteroides orales.