Safety profile and practical considerations of monoclonal antibody treatment

Monoclonal antibodies are immunoglobulins specially designed to act against specific targets, in such a way that their administration stops a specific pathogenic process, stimulates a particular cellular action, or changes a cell mechanism to another pathway of interest. Their production is based on the establishment of modified immortal B lymphocytes to produce a specific immunoglobulin. Depending on the level of purity, this immunoglobulin may be murine complement (ending in "o", for example muromonab); chimeric, in which all the immunoglobulin is human, except in the variable region which is murine (ending in "xi", for example, rituximab); humanised, in which all the immunoglobulin is human, except in the variable complement region which remains murine (ending in "zu", for example, natalizumab); and human complement (ending in "u", for example, adalimumab). Therefore, there will be two types of secondary effects: those arising from the action of the antibody, such as opportunistic infections due to immunosuppression, and those arising from the administration of a protein, such as anaphylactic reactions. The sources used for the present articles were articles published in PubMed, located by searching for "Monoclonal antibodies and Secondary effects", and the web pages of the European Medicines Agency (EMEA) and the US Food and Drus Administration (FDA).

The secondary effects arising from the mechanisms of action were opportunistic infections, common infections, development of tumours and autoimmune phenomena, and those arising from the administration of proteins: anaphylactic reaction, cytokine release syndrome, and the development of neutralising antibodies. Finally, the management of monoclonal antibodies in clinical practice and in special situations is discussed, including administering vaccines, pregnancy and paediatric use. Reference will be made to immune recovery syndrome.

Monoclonal antibodies are highly effective drugs when specifically indicated, but they also may incur serious secondary effects, which although incidence is low, require close monitoring of the patients receiving these treatments.