Long-term safety of biologic and targeted synthetic disease modifying drugs in rheumatology.

PURPOSE OF REVIEW: The landscape for treatment of rheumatic diseases is ever evolving, with several new drugs recently approved across diseases and more in the pipeline. This timely review aims to highlight the latest literature on long-term safety profiles of salient established and emerging biologic (b) and targeted synthetic (ts) disease modifying antirheumatic drugs (DMARDs).

RECENT FINDINGS: The risk of infection remains elevated with the use of most b and tsDMARDs, with specifically risk of hepatitis B reactivation with rituximab and zoster infection with JAK inhibitors (JAKi). The results of the ORAL surveillance trial led to new black box warnings for JAKi and evoked critical risk-benefit discussions surrounding JAKi and DMARDs overall.

SUMMARY: Such well conducted trials are needed to gather long term comparative safety data of DMARDs. In the interim, real world observational studies also have a role to play in our understanding of long-term drug safety, provided that detailed attention is paid to minimize biases inherent in observational studies.