Version 1
: Received: 22 April 2024 / Approved: 23 April 2024 / Online: 23 April 2024 (12:10:20 CEST)
How to cite:
Boada-Fernández-del-Campo, C.; García-Sánchez-Colomer, M.; Fernández-Quintana, E.; Poza-Guedes, P.; Rolingson-Landaeta, J.L.; Sánchez-Machín, I.; González-Pérez, R. Real-World Safety Profile of Biologic Drugs for Severe Uncontrolled Asthma: A Descriptive Analysis from the Spanish Pharmacovigilance Database. Preprints2024, 2024041515. https://doi.org/10.20944/preprints202404.1515.v1
Boada-Fernández-del-Campo, C.; García-Sánchez-Colomer, M.; Fernández-Quintana, E.; Poza-Guedes, P.; Rolingson-Landaeta, J.L.; Sánchez-Machín, I.; González-Pérez, R. Real-World Safety Profile of Biologic Drugs for Severe Uncontrolled Asthma: A Descriptive Analysis from the Spanish Pharmacovigilance Database. Preprints 2024, 2024041515. https://doi.org/10.20944/preprints202404.1515.v1
Boada-Fernández-del-Campo, C.; García-Sánchez-Colomer, M.; Fernández-Quintana, E.; Poza-Guedes, P.; Rolingson-Landaeta, J.L.; Sánchez-Machín, I.; González-Pérez, R. Real-World Safety Profile of Biologic Drugs for Severe Uncontrolled Asthma: A Descriptive Analysis from the Spanish Pharmacovigilance Database. Preprints2024, 2024041515. https://doi.org/10.20944/preprints202404.1515.v1
APA Style
Boada-Fernández-del-Campo, C., García-Sánchez-Colomer, M., Fernández-Quintana, E., Poza-Guedes, P., Rolingson-Landaeta, J.L., Sánchez-Machín, I., & González-Pérez, R. (2024). Real-World Safety Profile of Biologic Drugs for Severe Uncontrolled Asthma: A Descriptive Analysis from the Spanish Pharmacovigilance Database. Preprints. https://doi.org/10.20944/preprints202404.1515.v1
Chicago/Turabian Style
Boada-Fernández-del-Campo, C., Inmaculada Sánchez-Machín and Ruperto González-Pérez. 2024 "Real-World Safety Profile of Biologic Drugs for Severe Uncontrolled Asthma: A Descriptive Analysis from the Spanish Pharmacovigilance Database" Preprints. https://doi.org/10.20944/preprints202404.1515.v1
Abstract
The present study describes a comprehensive analysis of the Adverse Drug Reactions (ADRs) documented in the Database of the Spanish Pharmacovigilance System (FEDRA) concerning the use of biological medications used for severe refractory asthma, specifically omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab. Emphasis was placed on ADRs not documented in the Technical Sheet (Summary of Product Characteristics, SmPC) of the respective specialties (Xolair®, Nucala®, Cinqaero®, Fasenra®, Dupixent®, and Tezspire®), which could potentially trigger a warning signal in Pharmacovigilance, indicating previously unidentified risks. The analysis encompassed data from the inception of each drug ́s marketing until January 22, 2024, including cases originating from various sources: direct submissions to the Spanish Pharmacovigilance System, communications from the Pharmaceutical Industry, and findings from literature review. Notifications were analyzed independently of their origin, so a complete review of all ADRs associated with these medications was ensured. In essence, this investigation highlights the critical role of post-marketing safety information, emphasizing the relevance of comprehensive reporting by healthcare professionals to facilitate a robust Pharmacovigilance system, ultimately advancing patient care and safety.
Keywords
Severe asthma; Biologic Therapy; Safety; Adverse event; Pharmacovigilance.
Subject
Biology and Life Sciences, Other
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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