Challenges and approaches for the development of safer immunomodulatory biologics

Jean G. Sathish, Swaminathan Sethu, Marie Christine Bielsky, Lolke De Haan, Neil S. French, Karthik Govindappa, James Green, Christopher E M Griffiths, Stephen Holgate, David Jones, Ian Kimber, Jonathan Moggs, Dean J. Naisbitt, Munir Pirmohamed, Gabriele Reichmann, Jennifer Sims, Meena Subramanyam, Marque D. Todd, Jan Willem Van Der Laan, Richard J. WeaverB. Kevin Park

    Research output: Contribution to journalArticlepeer-review


    Immunomodulatory biologics, which render their therapeutic effects by modulating or harnessing immune responses, have proven their therapeutic utility in several complex conditions including cancer and autoimmune diseases. However, unwanted adverse reactions-including serious infections, malignancy, cytokine release syndrome, anaphylaxis and hypersensitivity as well as immunogenicity-pose a challenge to the development of new (and safer) immunomodulatory biologics. In this article, we assess the safety issues associated with immunomodulatory biologics and discuss the current approaches for predicting and mitigating adverse reactions associated with their use. We also outline how these approaches can inform the development of safer immunomodulatory biologics.
    Original languageEnglish
    Pages (from-to)306-324
    Number of pages18
    JournalNature Reviews Drug Discovery
    Issue number4
    Publication statusPublished - Apr 2013


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