Klin Farmakol Farm. 2025;39(2):77-83 | DOI: 10.36290/far.2025.034

The safety of biological and targeted therapies in rheumatology

Marta Olejárová

Revmatologický ústav, Revmatologická klinika 1. LF UK Praha

Biological and targeted synthetic agents have fundamentally transformed the thera­peutic approach to patients with inflammatory rheumatic diseases, including rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), and more recently also systemic lupus erythematosus (SLE) and systemic sclerosis (SSc). By targeting key components of the immune response, biologic therapies demonstrate superior efficacy and often a more favorable safety profile compared to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). However, biologic and targeted synthetic therapies are not without risks. The spectrum and nature of adverse events differ substantially from those associated with traditional immunosuppressants and require specific strategies for monitoring and management. This review focuses on the safety profiles of all currently available biological and targeted synthetic DMARDs (bDMARDs, tsDMARDs) used in the treatment of inflammatory rheumatic diseases, with an emphasis on practical clinical application. These agents include TNFα inhibitors, IL-6 inhibitors, co-stimulation blockers, anti-CD20 monoclonal antibodies, IL-17, IL-23, and IL-12/23 inhibitors, as well as agents targeting B-lymphocyte stimulator (BLYS) and type I interferons. Awareness of potential adverse effects, along with timely identification and management, are essential prerequisites for the safe, effective, and sustainable use of biologic therapies in clinical practice.

Keywords: inflammatory rheumatic diseases, biological therapy, targeted synthetic DMARDs, treatment safety, adverse effects, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, systemic lupus erythematosus, systemic scleroderma, TNFα inhibitors, IL-6 inhibitors, costimulation signal blockers, anti-CD20 monoclonal antibodies, IL-17 inhibitors, IL-23 inhibitors, IL-12/23 inhibitors, BLYS inhibitors (also known as BAFF inhibitors), type I interferon inhibitors.

Accepted: July 3, 2025; Published: July 4, 2025  Show citation