Biological Therapeutics (BTs) 
present a novel frontier for the treatment of 
autoimmune diseases, such as rheumatoid 
arthritis, psoriasis, Crohn's disease and several 
other conditions. BTs constitute highly selective 
compounds targeted upon specific structures that 
may be proteins, receptors, or DNA sequences. 
In the case of autoimmune diseases, the use of 
BTs is directed against pro-inflammatory 
cytokines that exert a central role in the 
inflammatory machinery. In the present review, 
attention is focused upon BTs that inhibit pro
inflammatory cytokines thereby blocking the 
inflammation, such as monoclonal antibodies 
(e.g. infliximab and adalimumab) and soluble 
receptors (e.g. etanercept). The interleukin-1 and 
interleukin-6 antagonists, 
anakinra
 and 
tocilizumab, rituximab, which decrease the 
number of circulating B-lymphocytes and 
abatacept, thereby counteracting T-lymphocyte 
activation, are described also. Despite the utility of BTs for patients presenting autoimmune 
diseases, they have been linked to opportunistic 
viral, bacterial, mycotic infections and to tumor 
cases. The occurrence of these pathologies is due 
to their immunosuppresssive functions thereby 
requiring
 the 
meticulous monitoring by 
pharmacovigilance and drug safety techniques to 
assess risk analysis. Whether or not Adverse 
Drug Events (ADEs) occur more frequently in 
patients
 administered
 BTs,
 compared to 
traditional drugs, is currently an essential topic 
of investigation.

 
Keywords: BTs; Cytokines; Infliximab; 
Adalimumab; 
Tocilizumab; 
Etanercept; 
Adverse 
drug 
Anakinra; 
reactions;  
Pharmacovigilance; 
Adverse drug effects;