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The outlook for alemtuzumab in multiple sclerosis.
BioDrugs. 2013 Jun; 27(3):181-9.B

Abstract

Alemtuzumab is a humanized anti-CD52 monoclonal antibody. Treatment in humans results in a rapid, profound, and prolonged B- and T-cell lymphopenia. Subsequently, lymphocyte reconstitution by homeostatic mechanisms alters the composition, phenotype, and function of T-cell subsets, thus allowing the immune system to be 'reset'. One phase II and two phase III randomized, multicenter, single-blinded (outcomes assessor) clinical trials of alemtuzumab in relapsing-remitting multiple sclerosis have now been completed. Against an active comparator and the current first-line therapy for relapsing-remitting multiple sclerosis (interferon-beta), alemtuzumab showed a significant reduction in annualized relapse rate as well as a significant reduction in the accumulation of disability. These outcomes are sustained over at least 5 years following treatment. The most common adverse effects are mild infusion reactions, an increased incidence of mild-to-moderate severity infections and secondary autoimmunity. The latter is observed in a third of treated patients, commonly thyroid disease but other target cells have been described including cytopenias. Marketing authorization applications have been submitted for the use of alemtuzumab in multiple sclerosis to the Food and Drug Administration and the European Medicines Agency, with licensing expected in 2013. Here, we discuss the outlook for alemtuzumab in multiple sclerosis in light of the currently available therapies, outcomes of and lessons learnt from clinical trials, and the overall position of monoclonal antibodies in modern treatment strategies.

Authors+Show Affiliations

Department of Clinical Neurosciences, Addenbrooke's Hospital, University of Cambridge, Box 165, Cambridge, CB2 0QQ, UK.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23558379

Citation

Williams, Thomas, et al. "The Outlook for Alemtuzumab in Multiple Sclerosis." BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy, vol. 27, no. 3, 2013, pp. 181-9.
Williams T, Coles A, Azzopardi L. The outlook for alemtuzumab in multiple sclerosis. BioDrugs. 2013;27(3):181-9.
Williams, T., Coles, A., & Azzopardi, L. (2013). The outlook for alemtuzumab in multiple sclerosis. BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy, 27(3), 181-9. https://doi.org/10.1007/s40259-013-0028-3
Williams T, Coles A, Azzopardi L. The Outlook for Alemtuzumab in Multiple Sclerosis. BioDrugs. 2013;27(3):181-9. PubMed PMID: 23558379.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The outlook for alemtuzumab in multiple sclerosis. AU - Williams,Thomas, AU - Coles,Alasdair, AU - Azzopardi,Laura, PY - 2013/4/6/entrez PY - 2013/4/6/pubmed PY - 2013/11/20/medline SP - 181 EP - 9 JF - BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy JO - BioDrugs VL - 27 IS - 3 N2 - Alemtuzumab is a humanized anti-CD52 monoclonal antibody. Treatment in humans results in a rapid, profound, and prolonged B- and T-cell lymphopenia. Subsequently, lymphocyte reconstitution by homeostatic mechanisms alters the composition, phenotype, and function of T-cell subsets, thus allowing the immune system to be 'reset'. One phase II and two phase III randomized, multicenter, single-blinded (outcomes assessor) clinical trials of alemtuzumab in relapsing-remitting multiple sclerosis have now been completed. Against an active comparator and the current first-line therapy for relapsing-remitting multiple sclerosis (interferon-beta), alemtuzumab showed a significant reduction in annualized relapse rate as well as a significant reduction in the accumulation of disability. These outcomes are sustained over at least 5 years following treatment. The most common adverse effects are mild infusion reactions, an increased incidence of mild-to-moderate severity infections and secondary autoimmunity. The latter is observed in a third of treated patients, commonly thyroid disease but other target cells have been described including cytopenias. Marketing authorization applications have been submitted for the use of alemtuzumab in multiple sclerosis to the Food and Drug Administration and the European Medicines Agency, with licensing expected in 2013. Here, we discuss the outlook for alemtuzumab in multiple sclerosis in light of the currently available therapies, outcomes of and lessons learnt from clinical trials, and the overall position of monoclonal antibodies in modern treatment strategies. SN - 1179-190X UR - https://www.unboundmedicine.com/medline/citation/23558379/The_outlook_for_alemtuzumab_in_multiple_sclerosis_ L2 - https://dx.doi.org/10.1007/s40259-013-0028-3 DB - PRIME DP - Unbound Medicine ER -