title: Challenges and approaches for the development of safer immunomodulatory biologics.
abstract: 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.
authors.affiliation: MRC Centre for Drug Safety Science and Institute of Translational Medicine, Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool L69 3GE, UK.
authors.forename: Jean G
authors.initials: JG
authors.lastname: Sathish
authors.forename: Swaminathan
authors.initials: S
authors.lastname: Sethu
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Bielsky
authors.forename: Lolke
authors.initials: L
authors.lastname: de Haan
authors.forename: Neil S
authors.initials: NS
authors.lastname: French
authors.forename: Karthik
authors.initials: K
authors.lastname: Govindappa
authors.forename: James
authors.initials: J
authors.lastname: Green
authors.forename: Christopher E M
authors.initials: CE
authors.lastname: Griffiths
authors.forename: Stephen
authors.initials: S
authors.lastname: Holgate
authors.forename: David
authors.initials: D
authors.lastname: Jones
authors.forename: Ian
authors.initials: I
authors.lastname: Kimber
authors.forename: Jonathan
authors.initials: J
authors.lastname: Moggs
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Naisbitt
authors.forename: Munir
authors.initials: M
authors.lastname: Pirmohamed
authors.forename: Gabriele
authors.initials: G
authors.lastname: Reichmann
authors.forename: Jennifer
authors.initials: J
authors.lastname: Sims
authors.forename: Meena
authors.initials: M
authors.lastname: Subramanyam
authors.forename: Marque D
authors.initials: MD
authors.lastname: Todd
authors.forename: Jan Willem
authors.initials: JW
authors.lastname: Van Der Laan
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Weaver
authors.forename: B Kevin
authors.initials: BK
authors.lastname: Park
mesh_terms: D000818:Animals; D001327:Autoimmune Diseases / Q000188:drug therapy / Q000276:immunology; D015195:Drug Design; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D009369:Neoplasms / Q000188:drug therapy / Q000276:immunology; D018570:Risk Assessment / Q000379:methods; D012308:Risk Management / Q000379:methods*
chemical_list: D007155:Immunologic Factors
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