Document Detail

Challenges and approaches for the development of safer immunomodulatory biologics.
MedLine Citation:
PMID:  23535934     Owner:  NLM     Status:  MEDLINE    
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.
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 Weaver; B Kevin Park
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Nature reviews. Drug discovery     Volume:  12     ISSN:  1474-1784     ISO Abbreviation:  Nat Rev Drug Discov     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-03-28     Completed Date:  2013-05-14     Revised Date:  2014-02-20    
Medline Journal Info:
Nlm Unique ID:  101124171     Medline TA:  Nat Rev Drug Discov     Country:  England    
Other Details:
Languages:  eng     Pagination:  306-24     Citation Subset:  IM    
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MeSH Terms
Autoimmune Diseases / drug therapy,  immunology
Drug Design*
Immunologic Factors / adverse effects*,  pharmacology,  therapeutic use
Neoplasms / drug therapy,  immunology
Risk Assessment / methods
Risk Management / methods*
Grant Support
G0700654//Medical Research Council; G0800766//Medical Research Council
Reg. No./Substance:
0/Immunologic Factors

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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