Biological therapy-associated adverse reactions in asthma

• Autor(a) principal: Sousa, José Luís Carneiro
• Data de Publicação: 2019
• Tipo de documento: Dissertação
• Idioma: eng
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10400.6/8767
• topic: Anticorpos Monoclonais; Asma; Efeitos Colaterais; Farmacoepidemiologia; Farmavigilância; Mepolizumab; Omalizumab; Reações Adversas Medicamentosas; Segurança; Domínio/Área Científica::Ciências Médicas::Ciências da Saúde::Medicina

Background Biological drugs have been successfully tested in asthma, being especially effective in the most severe forms of the disease. In parallel, safety issues have also emerged and have been recognized as a crucial aspect that needs to be monitored. The purpose of this study was to characterise the safety profile of biologicals used in asthma, by carrying out an analysis of Portuguese spontaneous reports (SR) of suspected adverse reactions to these drugs (ADR). Methods Retrospective analysis of SR of suspected ADR attributed to omalizumab and mepolizumab, sent to the National Pharmacovigilance System (SNF), since market launch until October 2018. We evaluated patients´ demographic data, as well as characteristics and seriousness of reactions. Results For omalizumab, from February 2006 to October 2018, there was an average annual reporting rate of 0.1978 reported cases per thousand severe asthmatics, with an increasing trend as years progressed. In the two years that mepolizumab has been subject to reports there was an average annual reporting rate of 0.1257 reported cases per thousand severe asthmatics. After all duplicate reports were removed, there was a total of 127 SR including 391 suspected ADR for omalizumab, and 10 SRs including 20 suspected ADRs for mepolizumab. For both omalizumab and mepolizumab the vast majority of patients were female (75.6% and 90.0%, respectively), and between 18 and 64 years old (61.4% and 50.0%, respectively). With omalizumab, the most frequent suspected ADRs were “respiratory, thoracic and mediastinal disorders”, “investigations” and “general disorders and administration site conditions”, according to System Organ Class (SOC), and “asthma”, “arthralgia” and “drug ineffective”, according to Preferred Term (PT). With mepolizumab, the most frequent suspected ADR were the “musculoskeletal and connective tissue disorders” and “general disorders and administration site conditions” SOCs, and the “arthralgia” PT. Regarding seriousness, 71.7% of the reports for omalizumab were serious, with a single fatal episode, 2 cases of anaphylaxis, 12 cases of malignant neoplasms and 2 abortions. Only 20.0% of the reports for mepolizumab were considered serious. Conclusions Despite limitations to this kind of study, our conclusions are in line with other studies, which show the favourable benefit-risk profile of this recent therapeutic approach. Our study also suggests that it is necessary to continue to develop educational programmes in order to get a better reporting system.