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Background and Importance Tezepelumab has demonstrated in clinical trials reductions in exacerbations and improved lung function in patients with uncontrolled severe asthma (USA). Nevertheless, practice-based evidence is still limited, and evaluation in routine clinical practice is needed to guide therapeutic decisions.Aim and Objectives To assess the real-world effectiveness and safety of tezepelumab in patients with USA after 12 months of treatment.Material and Methods A retrospective, observational study was conducted at a tertiary-level hospital, including patients who initiated treatment between November 2023 to September 2024. Data were obtained from electronic health records and included demographic variables (age, sex, body mass index (BMI), asthma phenotype and prior exposure to biologic therapy).Effectiveness outcomes were assessed through forced expiratory volume in one second (FEV1,%), forced vital capacity (FVC,%), FEV1/FVC ratio, fractional exhaled nitric oxide (FeNO, ppb), and blood eosinophil count (cells/μL), as well as Asthma Control Test (ACT) scores, annualised exacerbation rate, and oral corticosteroid cycles. Safety was evaluated by recording treatment-emergent adverse events.Statistical analyses were conducted with Stata v18. Parametric variables are expressed as mean±standard deviation and compared using paired t-test, while non-parametric variables are expressed as median (interquartile range) and compared using the Wilcoxon test. p-value<0.05 was considered statistically significant.Results Thirty-four patients were included, 85.3% were women, age 60.15±16.9, BMI 31.5±6.9, 85.3% presented type 2 asthma. 44.12% had received biologic therapy. The main outcomes were: Pre-Treatment Post-Treatment P-value FEV1 72.56±20.89 76.56±20.89 >0.05 ACT 12.67±4.72 17.18±4.72 <0.05 Corticosteroid cycles 2(1-2.75) 0(0-1) <0.05 FVC 85(71.25–94) 91(75–99.75) <0.05 FEV1/FVC ratio 66.63(62–73.5) 72(61.63–79) <0.05 FeNO 15.5(8.93–22) 9(5.75–15) <0.05 Eosinophils 200(0–350) 0(0–0) <0.05 Exacerbations 1(0–2) 0(0–1) <0.05 Exacerbations requiring hospitalisation 0(0–1) 0(0–0) <0.05 Regarding safety, a single case of lower limb pain was reported. Five interruptions were recorded: four due to lack of efficacy, and one due to patient decision.Conclusion and Relevance In real-world practice, tezepelumab was effective and tolerated, improving asthma control, reducing exacerbations and corticosteroid use, and decreasing inflammation biomarkers. Lung function showed a trend towards improvement without reaching statistical significance. Safety profile was favourable, although larger, controlled real-world studies are warranted to confirm these findings.Conflict of Interest No conflict of interest