Real-World Safety Profile of Biologics Used in Rheumatology: A Six-Year Observational Pharmacovigilance Study in the Calabria Region

• Main Authors: Agnese Gagliardi (Author), Francesco Salvatore Iaquinta (Author), Rosa Daniela Grembiale (Author), Caterina De Sarro (Author), Antonio Fabiano (Author), Domenico Fraija (Author), Caterina Palleria (Author), Rossella Romeo (Author), Adele Emanuela De Francesco (Author), Maria Diana Naturale (Author), Rita Citraro (Author), Luca Gallelli (Author), Antonio Leo (Author), Giovambattista De Sarro (Author)
• Format: Book
• Published: MDPI AG, 2022-10-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Summary

<b>Background:</b> The introduction of biological agents into the clinical armamentarium has modified the management of moderate-severe inflammatory arthritis (IA). However, these drugs can lead to serious adverse events (SAEs) and unpredictable adverse events (AEs) that are difficult to detect in pre-marketing clinical trials. This pharmacovigilance project aimed to study the AEs associated with biologics use in rheumatology. <b>Methods:</b> The current investigation is a multicenter, prospective, observational cohort study based on the Calabria Biologics Pharmacovigilance Program. Patients treated with one biologic agent from January 2016 to January 2022 were enrolled. <b>Results:</b> Overall, 729 (86.3%) of a total of 872 patients did not develop AEs or SAEs, whereas 143 (16.4%) patients experienced at least one AE, of which 16 (1.8%) had at least one SAE. The most common AEs were administration site conditions followed by gastrointestinal, nervous system and skin disorders. We reported a total of 173 switches and 156 swaps. Switches mainly occurred for inefficacy (136; 77.7%), whereas only 39 (22.3%) were due to the onset of an AE. Primary/secondary failure was the most frequent reason for swaps (124, 79%), while AEs onset led to 33 (21%) swaps. <b>Conclusions:</b> This study supports the validity of our program in monitoring and detecting AEs in the rheumatological area, confirming the positive beneficial/risk ratio of biologics.

Item Description

10.3390/pharmaceutics14112328
1999-4923