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Challenges and approaches for the development of safer immunomodulatory biologics

Moggs, Jonathan, Satish, Jean, Sethu, Swaminathan, Bielsky, Marie-Christine, de Haan, Lolke, French, Neil, Govindappa, Karthik, Green, James, Griffiths, Christopher, Holgate, Stephen, Jones, David, Kimber, Ian, Naisbitt, Dean, Pirmohamed, Munir, Reichmann, Gabriele, Sims, Jennifer, Subramanyam, Meena, Todd, Marque, van der Laan, Jan Willem, Weaver, Richard and Park, Kevin (2013) Challenges and approaches for the development of safer immunomodulatory biologics. Nature Reviews Drug Discovery, 12. pp. 306-324.


Immunomodulatory biologics are a class of agents that render their therapeutic effect via modulating or harnessing immune responses. Despite their therapeutic efficacy in complex conditions including cancer and autoimmune diseases, there is a growing concern about their unwanted adverse events including infections, malignancy, cytokine release syndromes, anaphylaxis, hypersensitivity and immunogenicity. In this article, we assess the safety issues associated with immunomodulatory biologics and discuss the key approaches to understand, predict and mitigate adverse events associated with their use.

Item Type: Article
Additional Information: This review article was derived from a UK CDSS Drug Safety Sciences workshop (December 2nd, 2012; Liverpool University) on "Challenges in the safety science of immunomodulatory antibodies and related therapeutics". Marketed Novartis therapeutic antibodies (e.g. Canakinumab) are mentioned in the context of their mechanism of action, indications and drug label safety information. All content has been presented in the public domain as part of the UK CDSS workshop or through published literature.
Keywords: biologics immunomodulatory safety
Date Deposited: 13 Oct 2015 13:14
Last Modified: 13 Oct 2015 13:14


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