Abstract
Highlights
- MS immunomodulatory drugs are associated with a variety of adverse reactions.
- Pharmacogenomics and clinical factors can optimize a drugs’ benefit/risk profile.
- The application of pharmacogenomics to MS is currently focused on drug response.
- We review target adverse drug reactions in MS for future research purposes.
Keywords
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- Case definition and phenotype standardization in drug-induced liver injury.Clinical Pharmacology and Therapeutics. 2011; 89: 806-815
- Adverse drug reactions: a review of relevant factors.Journal of Clinical Pharmacology. 2000; 40: 1093-1101
- Pharmacogenetic testing: time for clinical practice guidelines.Clinical Pharmacology and Therapeutics. 2011; 89: 924-927
Bayer Health Care Pharmaceuticals Inc. Betaseron (Interferon Beta-1b) for SC Injection Drug Monograph; 2011. Retrieved January 10, 2012 from 〈http://www.bayer.ca/files/BETASERON-PM-ENG-13JUL2011-133528.pdf〉
Biogen Idec. Avonex (Interferon-beta-1a) IM injection drug monograph; 2012a. Retrieved March 15, 2012 from 〈http://www.avonex.com/pdfs/guides/Avonex_Prescribing_Information.pdf〉.
Biogen Idec. Tysabri (Natalizumab) Drug Monograph; 2012b. Retrieved May 20, 2012 from 〈http://www.tysabrihcp.com/pdfs/I61061-13_PI.pdf〉.
- Risk of natalizumab-associated progressive multifocal leukoencephalopathy.The New England Journal of Medicine. 2012; 366: 1870-1880
- MSBase: an international, online registry and platform for collaborative outcomes research in multiple sclerosis.Multiple Sclerosis. 2006; 12: 769-774
- Adverse drug reaction active surveillance: developing a national network in Canada's children's hospitals.Pharmacoepidemiology and Drug Safety. 2009; 18: 713-721
- High-dose frequency beta-interferons increase the risk of liver test abnormalities in multiple sclerosis: a longitudinal study.Multiple Sclerosis. 2011; 17: 361-367
- Human polyomavirus JC (JCV) infection of human B lymphocytes: a possible mechanism for JCV transmigration across the blood-brain barrier.The Journal of Infectious Diseases. 2010; 202: 184-191
- Mechanism of action of oral fingolimod (FTY720) in multiple sclerosis.Clinical Neuropharmacology. 2010; 33: 91-101
- HLA class I and II alleles and response to treatment with interferon-beta in relapsing-remitting multiple sclerosis.Journal of Neuroimmunology. 2009; 210: 116-119
- McAlpine's multiple sclerosis. Churchill Livingstone, 2005
- ABC-transporter gene-polymorphisms are potential pharmacogenetic markers for mitoxantrone response in multiple sclerosis.Brain. 2009; 132: 2517-2530
- Genetic association studies in drug-induced liver injury.Seminars in Liver Disease. 2009; 29: 400-411
- Localized lipoatrophy after glatiramer acetate injection in patients with remitting-relapsing multiple sclerosis.Archives of Dermatology. 1999; 135: 1277-1278
- Lipoatrophy in patients with multiple sclerosis on glatiramer acetate.The Canadian Journal of Neurological Sciences. 2004; 31: 58-63
- Adverse drug reactions: definitions, diagnosis, and management.Lancet. 2000; 356: 1255-1259
- Therapy-related acute leukemia with Mitoxantrone: what is the risk and can we minimise it?.Multiple Sclerosis. 2009; 15: 505-508
EMD Serono Inc. Novantrone (mitoxantrone for injection concentrate) drug monograph; 2011a. Retrieved March 20, 2012 from 〈http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=56726〉.
EMD Serono Inc. Rebif (Interferon-beta-1a) SC injection drug monograph; 2011b. Retrieved March 20, 2012 from 〈http://www.emdserono.com/cmg.emdserono_us/en/images/rebif_tcm115_19765.pdf〉.
European Database for Multiple Sclerosis. EDMUS; 2012. Retrieved May 30, 2012 from 〈http://www.edmus.org/index.html〉
European Medicines Agency. European Medicines Agency starts review of Gilenya (fingolimod). Retrieved January 20, 2012 from 〈http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/01/news_detail_001425.jsp&mid=WC0b01ac058004d5c1&jsenabled=true〉.
FDA. Drug Safety Communication: Mitoxantrone hydrochloride (marketed as Novantrone and generics) – Healthcare Professional Sheet text version;. 2008. Retrieved January 1, 2012 from 〈http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126445.htm〉.
FDA. Drug Safety Communication: safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod); 2011. Retrieved January 1, 2012 from 〈http://www.fda.gov/Drugs/DrugSafety/ucm284240.htm〉.
FDA. Drug Safety Communication: New risk factor for progressive multifocal leukoencephalopathy (PML) associated with tysabri (natalizumab); 2012a. Retrieved January 20, 2012 from 〈http://www.fda.gov/Drugs/DrugSafety/ucm288186.htm〉.
FDA. FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod); 2012b. Retrieved May 14, 2012 from 〈http://www.fda.gov/Drugs/DrugSafety/ucm303192.htm〉.
FDA. Pharmacogenomic biomarkers in drug labels; 2012c. Retrieved March 1, 2012 from 〈http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=pharmacogenomic&utm_content=1〉.
- Hepatic reactions during treatment of multiple sclerosis with interferon-beta-1a: incidence and clinical significance.Drug Safety. 2003; 26: 815-827
- The pharmacogenetics research network: from SNP discovery to clinical drug response.Clinical Pharmacology and Therapeutics. 2007; 81: 328-345
- Pharmacogenetics of glatiramer acetate therapy for multiple sclerosis reveals drug-response markers.Pharmacogenetics and Genomics. 2007; 17: 657-666
- Pharmacogenomics: the importance of accurate phenotypes.Pharmacogenomics. 2010; 11: 469-470
- Functional energetics of CD4+-cellular immunity in monoclonal antibody-associated progressive multifocal leukoencephalopathy in autoimmune disorders.PLoS One. 2011; 6: e18506
- Risk of acute promyelocytic leukemia in multiple sclerosis: coding variants of DNA repair genes.Neurology. 2011; 76: 1059-1065
- Progressive lipoatrophy after cessation of glatiramer acetate injections: a case report.Multiple Sclerosis. 2009; 15: 521-522
Health Canada. Gilenya (fingolimod): MS drug under Health Canada review in light of serious adverse events. Retrieved February 27, 2012 from 〈http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_28-eng.php〉.
- Immune response to immunotherapy: the role of neutralising antibodies to interferon beta in the treatment of multiple sclerosis.Lancet Neurology. 2005; 4: 403-412
- Ageing populations, complex diseases and their challenge to 21st century healthcare: the focus of the European Society for Pharmacogenomics and Theranostics.Drug Metabolism and Drug Interactions. 2011; 26: 43-44
- Multiple sclerosis patients' benefit-risk preferences: serious adverse event risks versus treatment efficacy.Journal of Neurology. 2009; 256: 554-562
- Recent insights into the mechanism of action of glatiramer acetate.Journal of Neuroimmunology. 2011; 235: 9-17
- The mechanism of action of interferon-beta in relapsing multiple sclerosis.CNS Drugs. 2011; 25: 491-502
- Cardiotoxicity and other adverse events associated with mitoxantrone treatment for MS.Neurology. 2010; 74: 1822-1826
Kowalec K, Ross CJD, Smith MA, Traboulsee A, Yoshida EM, Marrie R.A., et al. Genotype specific approaches to preventing interferon beta-induced liver injury in multiple sclerosis: work in progress 2011. In: Pharmacogenomics and personalized medicine conference, Hinxton UK, Wellcome Trust Scientific Conferences Abstract P11.
- CXCL13 is the major determinant for B cell recruitment to the CSF during neuroinflammation.Journal of Neuroinflammation. 2012; 9: 93
- The heart rate decrease caused by acute FTY720 administration is mediated by the G protein-gated potassium channel I.American Journal of Transplantation. 2005; 5: 529-536
- Glatiramer acetate for multiple sclerosis.Cochrane Database of Systematic Reviews. 2010; : CD004678
- Interferon beta for secondary progressive multiple sclerosis.Cochrane Database of Systematic Reviews. 2012; 1: CD005181
- The emerging role of pharmacogenomics in biologics.Clinical Pharmacology and Therapeutics. 2007; 82: 466-471
- Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies.The Journal of the American Medical Association. 1998; 279: 1200-1205
- Anthracyclines, mitoxantrone, radiotherapy, and granulocyte colony-stimulating factor: risk factors for leukemia and myelodysplastic syndrome after breast cancer.Journal of Clinical Oncology. 2007; 25: 292-300
- Long-term safety profile of mitoxantrone in a French cohort of 802 multiple sclerosis patients: a 5-year prospective study.Multiple Sclerosis. 2011; 17: 867-875
- Cutaneous side-effects of immunomodulators in MS.International MS Journal. 2011; 17: 88-94
- Sphingosylphosphocholine is a naturally occurring lipid mediator in blood plasma: a possible role in regulating cardiac function via sphingolipid receptors.The Biochemical Journal. 2001; 355: 189-197
- Pharmacogenomics and active surveillance for serious adverse drug reactions in children.Pharmacogenomics. 2010; 11: 1269-1285
- Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis.Neurology. 1996; 46: 907-911
- Localized lipoatrophy after prolonged treatment with copolymer 1.Journal of Neurology. 2000; 247: 220-221
- Evidence report: the efficacy and safety of mitoxantrone (novantrone) in the treatment of multiple sclerosis: report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology.Neurology. 2010; 74: 1463-1470
- Acute myeloid leukemia in Italian patients with multiple sclerosis treated with mitoxantrone.Neurology. 2011; 77: 1887-1895
- Natalizumab treatment reduces endothelial activity in MS patients.Journal of Neuroimmunology. 2010; 227: 190-194
- Evaluation of the extent of under-reporting of serious adverse drug reactions: the case of toxic epidermal necrolysis.Drug Safety. 2004; 27: 477-487
- Antitumor agents. 1. 1,4-Bis[(aminoalkyl)amino]-9,10-anthracenediones.Journal of Medicinal Chemistry. 1979; 22: 1024-1030
- A method for estimating the probability of adverse drug reactions.Clinical Pharmacology and Therapeutics. 1981; 30: 239-245
Novartis Pharmaceuticals. Gilenya (Fingolimod capsules) drug monograph; 2012a. Retrieved May 20, 2012 from 〈http://www.pharma.us.novartis.com/product/pi/pdf/gilenya.pdf〉.
Novartis Pharmaceuticals. Novartis statement: Gilenya (Fingolimod) safety information update; 2012b. Retrieved May 30, 2012 from 〈http://www.novartis.com/downloads/newsroom/product-related-info-center/statement-PML.pdf〉.
- Masquerades of acquired demyelination in children: experiences of a national demyelinating disease program.Journal of Child Neurology. 2012; (epub 09 May 12)
- Fulminant hepatic failure and autoimmune disorders in patient with multiple sclerosis on interferon beta 1a: a fatal combination?.Transplant International. 2008; 21: 502-504
- Acceptance of biomarker-based tests for application in clinical practice: criteria and obstacles.Clinical Pharmacology and Therapeutics. 2010; 88: 862-866
- Pharmacogenetics: past, present and future.Drug Discovery Today. 2011; 16: 852-861
- The phenotype standardization project: improving pharmacogenetic studies of serious adverse drug reactions.Clinical Pharmacology and Therapeutics. 2011; 89: 784-785
- Phenotype standardization for immune-mediated drug-induced skin injury.Clinical Pharmacology and Therapeutics. 2011; 89: 896-901
- Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients.British Medical Journal. 2004; 329: 15-19
- Adipogenic gene variants in patients with HIV-associated lipodystrophy.Pharmacogenetics and Genomics. 2011; 21: 76-83
- CPIC: clinical pharmacogenetics implementation consortium of the pharmacogenomics research network.Clinical Pharmacology and Therapeutics. 2011; 89: 464-467
- Interferon in relapsing-remitting multiple sclerosis.Cochrane Database of Systematic Reviews. 2001; : CD002002
- Genetic variants in TPMT and COMT are associated with hearing loss in children receiving cisplatin chemotherapy.Nature Genetics. 2009; 41: 1345-1349
- Contribution of endermology to improving indurations and panniculitis/lipoatrophy at glatiramer acetate injection site.Advances in Therapy. 2012; 29: 267-275
- Pharmacogenomic biomarkers: validation needed for both the molecular genetic mechanism and clinical effect.Pharmacogenomics. 2011; 12: 675-680
- Factors that influence adherence and strategies to maintain adherence to injected therapies for patients with multiple sclerosis.Journal of Neuroscience Nursing. 2010; 42: S10-S18
- Personalizing medicine with clinical pharmacogenetics.Genetics in Medicine. 2011; 13: 987-995
- Universal health care, genomic medicine and Thailand: investing in today and tomorrow.Nature Reviews Genetics. 2008; 9: S14-S19
- Prediction of codeine toxicity in infants and their mothers using a novel combination of maternal genetic markers.Clinical Pharmacology and Therapeutics. 2012; 91: 692-699
- A role for syndecan-1 and claudin-2 in microbial translocation during HIV-1 infection.Journal of Acquired Immune Deficiency Syndromes. 2010; 55: 306-315
- Risk stratification for progressive multifocal leukoencephalopathy in patients treated with natalizumab.Multiple Sclerosis. 2012; 18: 143-152
Teva Pharmaceutical Industries Ltd. Copaxone (glatiramer acetate injection) drug monograph; 2011. Retrieved March 20, 2012 from 〈http://tevacanadainnovation.com/downloads/Copaxone_Product_Monograph_EN.pdf〉
- Liver injury associated with the beta-interferons for MS: a comparison between the three products.Neurology. 2004; 62: 628-631
- Mechanisms of drug-induced liver injury: from bedside to bench.Nature Reviews Gastroenterology & Hepatology. 2011; 8: 202-211
- Primary varicella zoster infection associated with fingolimod treatment.Neurology. 2011; 76: 1023-1024
US General Accounting Office. FDA drug review: postapproval risks 1976–85; 1990. Retrieved February 1, 2012 from 〈http://161.203.16.4/d24t8/141456.pdf〉.
- Implementation of pharmacogenetics in clinical practice is challenging.Pharmacogenomics. 2011; 12: 1231-1233
- United Europeans for development of pharmacogenomics in multiple sclerosis network.Pharmacogenomics. 2009; 10: 885-894
Vass K. Real-life use of natalizumab: safety data from the Austrian Nation-wide Natalizumab Registry. ECTRIMS, Amsterdam NL, Congrex Switzerland Ltd.; 2011 Abstract P977.
- Clinical outcomes of natalizumab-associated progressive multifocal leukoencephalopathy.Neurology. 2011; 76: 1697-1704
- A global agenda for a global challenge.Clinical Pharmacology and Therapeutics. 2012; 91: 747-750
- Pharmacogenomic prediction of anthracycline-induced cardiotoxicity in children.Journal of Clinical Oncology. 2011; (Epub September 2009)
- Fingolimod treatment for multiple sclerosis patients what do we do with varicella?.Annals of Neurology. 2011; 70 (author reply 74): 673-674
- Role of postmarketing surveillance in contemporary medicine.Annual Review of Medicine. 2011; 62: 1-10
World Health Organization-Uppsala Monitoring Centre. The use of the WHO-UMC system for standardized case causality assessment; 2012. Retrieved February 1, 2012 from 〈http://who-umc.org/Graphics/24734.pdf〉.
World Health Organization. Atlas: multiple sclerosis resources in the world. 2011. Retrieved October 28, 2011 from 〈http://www.who.int/mental_health/neurology/Atlas_MS_WEB.pdf〉
- Pediatric multiple sclerosis.Nature Reviews Neurology. 2009; 5: 621-631
- Fulminant liver failure during interferon beta treatment of multiple sclerosis.Neurology. 2001; 56: 1416
