Immunogenicity and other problems associated with the use of biopharmaceuticals
暂无分享,去创建一个
[1] J. Vielmetter,et al. Clinical link between MHC class II haplotype and interferon-beta (IFN-beta) immunogenicity. , 2006, Clinical immunology.
[2] A. Gottlieb,et al. Induction and exacerbation of psoriasis with TNF-blockade therapy: A review and analysis of 127 cases , 2009, The Journal of dermatological treatment.
[3] S. Grossberg,et al. The neutralization of interferons by antibody III. The constant antibody bioassay, a highly sensitive quantitative detector of low antibody levels. , 2009, Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research.
[4] A. Alshekhlee,et al. Chronic inflammatory demyelinating polyneuropathy associated with tumor necrosis factor‐α antagonists , 2010, Muscle & nerve.
[5] Rosenberg As. Immunogenicity of biological therapeutics: a hierarchy of concerns. , 2003, Developments in biologicals.
[6] J. Paues,et al. Fatal progressive multifocal leukoencephalopathy in a patient with non-Hodgkin lymphoma treated with rituximab. , 2010, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.
[7] K. Selmaj,et al. Experimental autoimmune encephalomyelitis , 1995, Neurology.
[8] M. Kudo,et al. Association of genetic polymorphisms with interferon‐induced haematologic adverse effects in chronic hepatitis C patients , 2009, Journal of viral hepatitis.
[9] G. Weiner,et al. Rituximab: mechanism of action. , 2010, Seminars in hematology.
[10] M. Sahraian,et al. Alemtuzumab and multiple sclerosis: therapeutic application. , 2010, Expert opinion on biological therapy.
[11] T. McCormick,et al. Severe dermatomyositis triggered by interferon beta-1a therapy and associated with enhanced type I interferon signaling. , 2008, Archives of dermatology.
[12] N. C. Hamilton,et al. Mechanisms of fever induced by recombinant human interferon. , 1984, The Journal of clinical investigation.
[13] F. Wolfe,et al. Skin cancer, rheumatoid arthritis, and tumor necrosis factor inhibitors. , 2005, The Journal of rheumatology.
[14] D. Clifford,et al. Natalizumab-associated progressive multifocal leukoencephalopathy. , 2012 .
[15] E. Major,et al. JC virus persistence following progressive multifocal leukoencephalopathy in multiple sclerosis patients treated with natalizumab , 2010, Annals of neurology.
[16] E. Yacyshyn,et al. The development of systemic sclerosis in a female patient with multiple sclerosis following beta interferon treatment , 2008, Clinical Rheumatology.
[17] H. Kazazian,et al. Correlation between Factor VIII Genotype and Inhibitor Development in Hemophilia A , 2000, Seminars in thrombosis and hemostasis.
[18] G. Giovannoni,et al. Current and future role of interferon beta in the therapy of multiple sclerosis. , 2010, Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research.
[19] William M. Lee,et al. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. , 2009, The New England journal of medicine.
[20] M. Fujimoto,et al. Association study of a polymorphism of the CTGF gene and susceptibility to systemic sclerosis in the Japanese population , 2008, Annals of the rheumatic diseases.
[21] L. Gluud,et al. Cochrane systematic review: pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C , 2007, Alimentary pharmacology & therapeutics.
[22] R Thorpe,et al. Kinetics of development and characteristics of antibodies induced in cancer patients against yeast expressed rDNA derived granulocyte macrophage colony stimulating factor (GM-CSF). , 2005, Cytokine.
[23] E. Ferrannini,et al. Thyroid autoimmunity and dysfunction associated with type I interferon therapy , 2004, Clinical and Experimental Medicine.
[24] M. Carroll,et al. Use of tumor necrosis factor α inhibitors in hepatitis B surface antigen-positive patients: a literature review and potential mechanisms of action , 2010, Clinical Rheumatology.
[25] G. Schernthaner,et al. Immunogenicity and Allergenic Potential of Animal and Human Insulins , 1993, Diabetes Care.
[26] P. Fenaux,et al. SPOTLIGHT REVIEW Interferon-a therapy in bcr-abl-negative myeloproliferative neoplasms , 2008 .
[27] Anne S De Groot,et al. Immunogenicity of protein therapeutics. , 2007, Trends in immunology.
[28] David Green,et al. Progressive multifocal leukoencephalopathy after rituximab therapy in HIV-negative patients: a report of 57 cases from the Research on Adverse Drug Events and Reports project. , 2009, Blood.
[29] G. Keating. Rituximab: a review of its use in chronic lymphocytic leukaemia, low-grade or follicular lymphoma and diffuse large B-cell lymphoma. , 2010, Drugs.
[30] A. Meager. Measurement of cytokines by bioassays: theory and application. , 2006, Methods.
[31] I. Buchan,et al. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. , 2006, JAMA.
[32] L. Peyrin-Biroulet,et al. Anti-TNF therapy in inflammatory bowel diseases: a huge review. , 2010, Minerva gastroenterologica e dietologica.
[33] S. Misbah,et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. , 2008, The New England journal of medicine.
[34] Stefan Sleijfer,et al. Side Effects of Interferon-α Therapy , 2005, Pharmacy World and Science.
[35] A. Bowie,et al. Sensing and Signaling in Antiviral Innate Immunity , 2010, Current Biology.
[36] G. Rice,et al. Interferon β-1a in MS , 2005, Neurology.
[37] P. Lebon,et al. Quantification of neutralizing antibodies to human type I interferons using division-arrested frozen cells carrying an interferon-regulated reporter-gene. , 2008, Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research.
[38] A. Somani,et al. Type I IFNs and their role in the development of autoimmune diseases , 2009, Expert opinion on drug safety.
[39] F. Breedveld,et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. , 1998, Arthritis and rheumatism.
[40] P. Annunziata,et al. Long time interval between multiple sclerosis onset and occurrence of primary Sjögren's syndrome in a woman treated with interferon‐beta , 2005, Acta neurologica Scandinavica.
[41] A. Masumoto,et al. Development of Sjögren's syndrome during treatment with recombinant human interferon-alpha-2b for chronic hepatitis C , 1996, Journal of Gastroenterology.
[42] I. Fajardy,et al. STAT4 is a genetic risk factor for systemic sclerosis having additive effects with IRF5 on disease susceptibility and related pulmonary fibrosis. , 2009, Arthritis and rheumatism.
[43] R. Landewé,et al. Current evidence for the management of rheumatoid arthritis with biological disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of RA , 2010, Annals of the rheumatic diseases.
[44] V. Pascual,et al. Cross-regulation of TNF and IFN-¿ in autoimmune diseases , 2005 .
[45] N. Dafny,et al. Interferon and the central nervous system. , 2005, European journal of pharmacology.
[46] R. Dillman,et al. Optimizing the use of rituximab for treatment of B-cell non-Hodgkin's lymphoma: a benefit-risk update. , 2000, Seminars in oncology.
[47] G. Karypis,et al. Interferon-inducible gene expression signature in peripheral blood cells of patients with severe lupus , 2003, Proceedings of the National Academy of Sciences of the United States of America.
[48] B. Zimmermann,et al. Drug-Induced Lupus due to Anti-Tumor Necrosis Factor α Agents , 2008 .
[49] D. Furst. The risk of infections with biologic therapies for rheumatoid arthritis. , 2010, Seminars in arthritis and rheumatism.
[50] J. M. Harris,et al. Pegylation: a novel process for modifying pharmacokinetics. , 2001, Clinical pharmacokinetics.
[51] D. C. Graham,et al. Association of polymorphisms across the tyrosine kinase gene, TYK2 in UK SLE families. , 2007, Rheumatology.
[52] Malorye Allison. PML problems loom for Rituxan , 2010, Nature Biotechnology.
[53] P. Coyle. The role of natalizumab in the treatment of multiple sclerosis. , 2010, The American journal of managed care.
[54] M. Sharief,et al. Association between Tumor Necrosis Factor-α and Disease Progression in Patients with Multiple Sclerosis , 1991 .
[55] S. Suissa,et al. Demyelinating events in rheumatoid arthritis after drug exposures , 2009, Annals of the rheumatic diseases.
[56] M. E. Reid,et al. Thrombocytopenia caused by the development of antibodies to thrombopoietin , 2002 .
[57] R. Jonsson,et al. Additive effects of the major risk alleles of IRF5 and STAT4 in primary Sjögren's syndrome , 2009, Genes and Immunity.
[58] R Thorpe,et al. Immunogenicity of granulocyte-macrophage colony-stimulating factor (GM-CSF) products in patients undergoing combination therapy with GM-CSF. , 1999, Clinical cancer research : an official journal of the American Association for Cancer Research.
[59] Herbert J Meiselman,et al. Antibody against poly(ethylene glycol) adversely affects PEG‐asparaginase therapy in acute lymphoblastic leukemia patients , 2007, Cancer.
[60] R. Bergamaschi,et al. Melanoma in multiple sclerosis treated with natalizumab: causal association or coincidence? , 2009, Multiple sclerosis.
[61] D. Goodin,et al. Neutralizing Antibodies to Interferon β-1b are not Associated with Disease Worsening in Multiple Sclerosis , 2007 .
[62] L. Kappos,et al. Neutralizing antibodies and efficacy of interferon β-1a , 2005, Neurology.
[63] D Vergani,et al. Type 1 diabetes mellitus in patients with chronic hepatitis C before and after interferon therapy , 2003, Alimentary pharmacology & therapeutics.
[64] E. Heathcote. Autoimmune hepatitis and chronic hepatitis C: latent or initiated by interferon therapy? , 1995, Gastroenterology.
[65] A. Uccelli,et al. Association of melanoma and natalizumab therapy in the Italian MS population: a second case report , 2011, Neurological Sciences.
[66] S. Yılmaz,et al. Pegylated interferon alfa-2B induced lupus in a patient with chronic hepatitis B virus infection: case report , 2009, Clinical Rheumatology.
[67] J. Kere,et al. Evidence for Genetic Association and Interaction Between the TYK2 and IRF5 Genes in Systemic Lupus Erythematosus , 2009, The Journal of Rheumatology.
[68] Patrick Mayeux,et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. , 2002, The New England journal of medicine.
[69] G. Kullak-Ublick,et al. Diagnosis of melanoma under concomitant natalizumab therapy , 2011, Multiple sclerosis.
[70] M. Albertini,et al. Dermatomyositis after interferon alpha treatment , 2000, Medical oncology.
[71] A. Noronha. Neutralizing antibodies to interferon , 2007, Neurology.
[72] J. Berger. Progressive Multif ocal Leukoencephalopathy and Newer Biological Agents , 2010, Drug safety.
[73] X. Mariette,et al. Association of an IRF5 gene functional polymorphism with Sjögren's syndrome. , 2007, Arthritis and rheumatism.
[74] J. Macías,et al. Predictors of Severe Haematological Toxicity Secondary to Pegylated Interferon plus Ribavirin Treatment in HIV-HCV-Coinfected Patients , 2007, Antiviral therapy.
[75] D. C. Linch,et al. Development of antibodies to unprotected glycosylation sites on recombinant human GM-CSF , 1990, The Lancet.
[76] P. Lebon,et al. One-step assay for quantification of neutralizing antibodies to biopharmaceuticals. , 2010, Journal of immunological methods.
[77] B. Manger,et al. New onset of rheumatoid arthritis during interferon beta-1B treatment in a patient with multiple sclerosis: comment on the case report by Jabaily and Thompson. , 1998, Arthritis and rheumatism.
[78] C. Wendtner,et al. Oncotargets and Therapy Dovepress Open Access to Scientific and Medical Research Open Access Full Text Article Dovepress First-line Treatment of Chronic Lymphocytic Leukemia: Role of Alemtuzumab Clinical and Biological Heterogeneity of Cll Requires Risk-adapted Patient Management in Prospective Clin , 2022 .
[79] P. Hauser,et al. Mood and cognitive side effects of interferon-α therapy , 1998 .
[80] Xavier Montalban,et al. Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta , 2010, The Lancet Neurology.
[81] G. Giovannoni. Strategies to treat and prevent the development of neutralizing anti-interferon-β antibodies , 2003, Neurology.
[82] S. Kirshner. Immunogenicity of Therapeutic Proteins: A Regulatory Perspective , 2011 .
[83] P. Tak,et al. Inhibition of joint damage and improved clinical outcomes with rituximab plus methotrexate in early active rheumatoid arthritis: the IMAGE trial , 2010, Annals of the rheumatic diseases.
[84] Lack of association between tyrosine kinase 2 (TYK2) gene polymorphisms and susceptibility to SLE in a Japanese population , 2009, Modern rheumatology.
[85] V. Pascual,et al. Cross-regulation of TNF and IFN-alpha in autoimmune diseases. , 2005, Proceedings of the National Academy of Sciences of the United States of America.
[86] K. Selmaj,et al. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. , 2008, The New England journal of medicine.
[87] M. Dicato,et al. Erythropoietin in cancer patients: pros and cons , 2010, Current opinion in oncology.
[88] S. Kim,et al. The neutralization of type I IFN biologic actions by anti-IFNAR-2 monoclonal antibodies is not entirely due to inhibition of Jak-Stat tyrosine phosphorylation. , 2000, Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research.
[89] R. Scorza,et al. The STAT4 gene influences the genetic predisposition to systemic sclerosis phenotype. , 2009, Human molecular genetics.
[90] J. Gómez-Reino,et al. Demyelinating disease in patients treated with TNF antagonists in rheumatology: data from BIOBADASER, a pharmacovigilance database, and a systematic review. , 2011, Seminars in arthritis and rheumatism.
[91] J. Stockman. Daclizumab to Prevent Rejection After Cardiac Transplantation , 2007 .
[92] Huub Schellekens,et al. Aggregated Recombinant Human Interferon Beta Induces Antibodies but No Memory in Immune-Tolerant Transgenic Mice , 2010, Pharmaceutical Research.
[93] P. Hauser,et al. Mood and cognitive side effects of interferon-alpha therapy. , 1998, Seminars in oncology.
[94] T. Waldmann,et al. Regulatory CD56(bright) natural killer cells mediate immunomodulatory effects of IL-2Ralpha-targeted therapy (daclizumab) in multiple sclerosis. , 2006, Proceedings of the National Academy of Sciences of the United States of America.
[95] M. Colombo,et al. Opposite immune functions of GM-CSF administered as vaccine adjuvant in cancer patients. , 2006, Annals of oncology : official journal of the European Society for Medical Oncology.
[96] J. Oberholzer,et al. Interleukin-2 receptor blockade with humanized monoclonal antibody for solid organ transplantation , 2010, Expert opinion on biological therapy.
[97] A. Duchini. Autoimmune hepatitis and interferon beta-1a for multiple sclerosis , 2002, American Journal of Gastroenterology.
[98] R. D. Du Pasquier,et al. Demyelination as a complication of new immunomodulatory treatments , 2010, Current opinion in neurology.
[99] B. Zimmermann,et al. Drug-induced lupus due to anti-tumor necrosis factor alpha agents. , 2008, Seminars in arthritis and rheumatism.
[100] W. Dixon,et al. Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register (BSRBR) , 2009, Annals of the rheumatic diseases.
[101] W V Moore,et al. Role of aggregated human growth hormone (hGH) in development of antibodies to hGH. , 1980, The Journal of clinical endocrinology and metabolism.
[102] D. Miller,et al. The incidence and significance of anti-natalizumab antibodies , 2007, Neurology.
[103] B. Sharrack,et al. Melanoma complicating treatment with Natalizumab (Tysabri) for multiple sclerosis , 2009, Journal of Neurology.
[104] M. Bagot,et al. Psoriasis induced by tumor necrosis factor-alpha antagonist therapy: a case series. , 2007, The Journal of rheumatology.
[105] P. Bahadoran,et al. Evolution of nevi during treatment with natalizumab: A prospective follow-up of patients treated with natalizumab for multiple sclerosis. , 2010, Archives of dermatology.
[106] J. Stone. Etanercept plus Standard Therapy for Wegener's Granulomatosis , 2005 .
[107] Quynh-Thu Le,et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. , 2008, The New England journal of medicine.
[108] M. Si-Tahar,et al. A loss-of-function variant of the antiviral molecule MAVS is associated with a subset of systemic lupus patients , 2011, EMBO Molecular Medicine.
[109] M. Fujimoto,et al. Association of a functional polymorphism in the IRF5 region with systemic sclerosis in a Japanese population. , 2009, Arthritis and rheumatism.
[110] L. Rönnblom,et al. The type I interferon system in systemic lupus erythematosus. , 2006, Arthritis and rheumatism.
[111] Marta E Alarcón-Riquelme,et al. A common haplotype of interferon regulatory factor 5 (IRF5) regulates splicing and expression and is associated with increased risk of systemic lupus erythematosus , 2006, Nature Genetics.
[112] X. Mariette,et al. The CGGGG insertion/deletion polymorphism of the IRF5 promoter is a strong risk factor for primary Sjögren's syndrome. , 2009, Arthritis and rheumatism.
[113] D. Jeffery,et al. Interferon-beta1A-induced polyarthritis in a patient with the HLA-DRB1*0404 allele. , 1999, Arthritis and rheumatism.
[114] G. Herrero-Beaumont,et al. Rheumatoid arthritis does not share most of the newly identified systemic lupus erythematosus genetic factors. , 2009, Arthritis and rheumatism.
[115] W. Jiskoot,et al. Aggregation and Immunogenicity of Therapeutic Proteins , 2010 .
[116] T. Hayakawa,et al. Japanese Regulatory Perspective on Immunogenicity , 2011 .
[117] R. Rudick,et al. Natalizumab for the treatment of relapsing multiple sclerosis , 2008, Biologics : targets & therapy.
[118] A. Bertolotto,et al. Neutralizing antibodies reduce the efficacy of βIFN during treatment of multiple sclerosis , 2004, Neurology.
[119] M. Calaza,et al. Replication of recently identified systemic lupus erythematosus genetic associations: a case–control study , 2009, Arthritis research & therapy.