Descripció del contingut i pla d'activitats:
Es vol avaluar l'efecte de la introducció del fàrmac Nirsevimab per als nadons a Catalunya. Nirsevimab és un anticós monoclonal que té per objectiu proporcionar als nadons protecció front al virus respiratori sincitial. L'octubre de 2023 es va iniciar la seva utilització a Catalunya. S'avaluaran les dades de les sèries històriques de diagnòstics de bronquiolitis i deteccions de VRS diàries. S'analitzaran les seves dinàmiques pre-pandèmia i post-pandèmia. S'avaluarà també l'impacte que ha tingut aquest medicament en les prèviament estudiades dinàmiques històriques de VRS i Bronquiolitis.
Per a aquests anàlisi, s'utilitzarà o bé el programari Python o bé MATLAB.
L'objectiu del treball és estudiar les noves dinàmiques de VRS i Bronquiolitis i veure quin paper ha pogut jugar el Nirsevimab en elles. Si les dades ho permeten, avaluar l'efectivitat del Nirsevimab a Catalunya comparant grup control amb grup que ha rebut el medicament.
El treball es realitza en col·laboració amb el pediatre Dr. Antoni Soriano de l'Hospital Vall d'Hebron.
Overview (resum en anglès):
The respiratory syncytial virus (RSV) causes 70% of bronchiolitis cases and thousands of annual deaths, particularly in the paediatric population under six months, placing a significant burden on the public health system. In October 2023, the monoclonal antibody nirsevimab was implemented for the first time in Catalonia in infants to combat the most severe clinical episodes caused by this virus.
The primary objective of this study is to evaluate the impact of the first immunisation campaign with nirsevimab on the epidemiology and clinical outcomes of RSV. To this end, pre-pandemic patterns by age group have been characterized and compared with the current season, in addition to analysing the clinical outcomes of a prospective cohort of infants, observing differences between those who received nirsevimab and those who did not.
The methodology followed in this study is divided into two major analyses: an epidemiological study and a patient-level study. The epidemiological analysis involves exploring the dynamics of bronchiolitis as an indirect measure of RSV and of the virus itself, conducting comparative analyses using an average pre-pandemic season and differentiating between various age groups. The patient-level analysis consists of a prospective study of clinical variables comparing a cohort that received nirsevimab with another cohort that did not.
The results indicate that the pre-pandemic incidence of bronchiolitis followed a very robust pattern each season, which was significantly affected by the pandemic. It has been observed that the introduction of nirsevimab has reduced the incidence of RSV in infants under one year. Additionally, the prospective study determined that infants receiving nirsevimab are less likely to test positive for RSV and develop lower respiratory tract infections compared to those who were not immunised.
In conclusion, this study demonstrates that the administration of nirsevimab in Catalonia has reduced the incidence of RSV and lower respiratory infections among infants, suggesting a protective effect against the virus. These results can modestly guide future immunisation campaigns against RSV and encourage further studies in this direction.