Abstract
The last decade was characterized by the successive introduction of several biological agents for the treatment of autoimmune rheumatic diseases (ARD). Randomized controlled trials (RCT) proved them to have globally acceptable safety and tolerability profiles. However, life-threatening complications are rare events and RCT are underpowered to detect them. As these drugs became more widely prescribed in clinical practice, and particularly, having the information from multiple national biologics registries available, serious adverse events became perceptible. Infection remains the major concern, but other serious and life-threatening complications have emerged, such as malignancies, congestive heart failure, demyelinating disorders, and drug-induced autoimmune syndromes. Several of these are correlated with either the underlying disease or concomitant immunosuppressive medication. Most of them can be avoided by the adoption of preventive measures and an early proper management might significantly change the outcome. Awareness of the possible serious side effects is of utmost importance for a safer use of biological agents. In this chapter, we aim to describe the most commonly reported life-threatening complications of biological therapies in the literature – including those with antitumor necrosis factor agents, rituximab, abatacept, tocilizumab, and anakinra. Risk groups are identified and strategies for the prevention and initial management are included.