Biological therapy-associated adverse reactions in asthma: analysis of reporting to the Portuguese pharmacovigilance system

Objectives: Biological drugs have been successfully tested in asthma, especially in the most severe forms of the disease. The goal of this study was to characterize the safety profile of biologicals used in asthma. Methods: Retrospective and descriptive analysis of spontaneous reports (SRs) involving omalizumab and mepolizumab, sent to the Portuguese Pharmacovigilance System, since market launch until October 2018. Results: A total of 127 SRs for omalizumab and 10 SRs mepolizumab were found. Most patients were female (75.6% omalizumab and 90.0% mepolizumab), and aged 18-64 years (61.4% and 50.0%, respectively). 71.7% of the reports for omalizumab were serious, with 2 cases of anaphylaxis, 12 malignant neoplasms and 2 abortions. Only 20.0% of the reports for mepolizumab were considered serious. A total of 391 adverse drug reactions (ADRs) for omalizumab and 20 ADRs for mepolizumab were found. Most reported ADRs belonged to System organ class (SOC) groups: 'respiratory, thoracic and mediastinal disorders' and 'investigations', for omalizumab; 'musculoskeletal and connective tissue disorders' and 'general disorders and administration site conditions' for mepolizumab. Conclusion: Over the years, there was an increasing trend of SRs with these biological drugs. However, it is necessary to continue to develop educational programs in order to get a better reporting system.