OBJECTIVES: The aim of this retrospective study was to evaluate the effectiveness, safety and costs of biological therapy in asthma using hospital real-world data.

METHODS: Data was collected from EHR during the period from 2007 till May 2021 in Centro Hospitalar e Universitário São João. The number of exacerbations requiring hospitalisation and/or emergency department visit, the use of oral corticosteroids (OC), FEV1 and ASC score before and 12 months after the beginning of biological therapy were compared. The suspected ADR were also collected. Statistical analysis was performed using IBM®SPSS® Statistics 27^th version.

RESULTS: A total of 66 patients, 82% female and with the mean age of 51,9 (SD=11,2), were included in our study. A decrease in the mean daily OC dose of 8,28 mg (p value<0,001) and in the mean number of OC cycles of 2,06 (p value <0,001) was observed after biological started. During the period of 12 months of biological treatment both percentages of ER visits and hospitalisations decreased significantly to 28,2% (95%CI 10,9-45,5) and 17,3% [95% CI 5,7- 28,9) respectively. 12 months after the start of the biological, the median ACT score was 22,00 (VAR=21,1) and the mean FEV1 was 2,0 (SD =0,8) having the difference no statistical significance. Apart from one case of anaphylactic reaction 20 minutes after the administration of the suspected drug (mepolizumab), the adverse drug reactions (ADR) collected were not serious. The mean monthly cost associated with the treatment with: omalizumab was 1 024,23 € (SD=644,47 €), mepolizumab was 1 145,10 € (SD=555,47 €), reslizumab was 828,41€ (SD=244,58 €) and benralizumab was 1 692,49 € (SD=444,51€).

CONCLUSIONS: Results with biological therapies in real-life clinical context are comparable to those reported in clinical trials. Biological therapy reduces oral corticosteroid use and the number of exacerbations requiring hospitalisation and/or emergency department visit without important adverse effects associated.