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Published on: June 6, 2025
Real-World Evolution of Prescribing Patterns and Safety Profiles of Biologic and Targeted Synthetic Therapies in
Antonio Fabiano1, Lorenza Guarnieri1, Domenico Frajia1
1Department of Health Sciences, University "Magna Graecia" of Catanzaro, 88100 Catanzaro, Italy.
Abstract:
Background/Objectives: Biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) have expanded treatment options for inflammatory rheumatic diseases, highlighting the need for continuous pharmacovigilance. This study evaluated changes in prescribing patterns and safety profiles of b/tsDMARDs between 2018-2019 and 2023-2024 in routine clinical practice. Methods: A retrospective observational study was conducted in patients with rheumatoid arthritis (AR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), or juvenile idiopathic arthritis (JIA) treated at a rheumatology outpatient clinic in Southern Italy. Demographic and clinical characteristics, prescribed therapies, treatment switches/swaps, therapeutic failures, and adverse events (AEs) were collected through a structured pharmacovigilance program. Prescribing trends between the two study periods were compared using chi-square analysis. Results: A total of 342 patients were included (202 in 2018-2019 and 140 in 2023-2024). Prescribing patterns changed significantly over time (χ2 = 83.24, p < 0.0001), with increased use of newer therapeutic classes and biosimilars, while tumor necrosis factor (TNF) inhibitors remained the most frequently prescribed drugs. The proportion of biologic-naïve patients increased from 52.0% to 66.4%, whereas AEs decreased from 31.7% to 15.0%, with no serious adverse events (SAEs) reported. Conclusions: Prescribing strategies for inflammatory rheumatic diseases evolved substantially between 2018 and 2024, reflecting the availability of new therapeutic options and a more personalized treatment approach. b/tsDMARDs showed a favorable real-world safety profile, supporting the importance of ongoing pharmacovigilance.
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