The safety and side effects of monoclonal antibodies (original) (raw)
Köhler, G. & Milstein, C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature256, 495–497 (1975). The original manuscript describing the breakthrough of hybridoma technology and the production of mAbs. ArticlePubMed Google Scholar
Strebhardt, K. & Ullrich, A. Paul Ehrlich's magic bullet concept: 100 years of progress. Nature Rev. Cancer8, 473–480 (2008). ArticleCAS Google Scholar
Dubel, S. (ed.) Handbook of Therapeutic Antibodies. Volume I: Technologies, Volume II: Emerging Developments, Volume III: Approved Therapeutics (Wiley, Weinhem, 2007). A comprehensive three volume multiple-author text on therapeutic antibodies. Book Google Scholar
Lonberg, N. Human antibodies from transgenic animals. Nature Biotech.23, 1117–1125 (2005). ArticleCAS Google Scholar
Reichert, J. M., Rosensweig, C. J., Faden, L. B. & Dewitz, M. C. Monoclonal antibody successes in the clinic. Nature Biotech.23, 1073–1078 (2005). ArticleCAS Google Scholar
Reichert, J. M. & Dewitz, M. C. Anti-infective monoclonal antibodies: perils and promise of development. Nature Rev. Drug Discov.5, 191–195 (2006). ArticleCAS Google Scholar
Leader, B., Baca, Q. J. & Golan, D. E. Protein therapeutics: a summary and pharmacological classification. Nature Rev. Drug Discov.7, 21–39 (2008). ArticleCAS Google Scholar
Nissim, A. & Chernajovsky, Y. Historical development of monoclonal antibody therapeutics. Handb. Exp. Pharmacol.181, 3–18 (2008). ArticleCAS Google Scholar
Presta, L. G. Molecular engineering and design of therapeutic antibodies. Curr. Opin. Immunol.20, 460–470 (2008). ArticleCASPubMed Google Scholar
Hale, G. Therapeutic antibodies-delivering the promise? Adv. Drug Deliv. Rev58, 633–639 (2006). ArticleCASPubMed Google Scholar
Tracey, D., Klareskog, L., Sasso, E. H., Salfeld, J. G. & Tak, P. P. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol. Ther.117, 244–279 (2008). ArticleCASPubMed Google Scholar
Giezen, T. J. et al. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA300, 1887–1896 (2008). An important review of regulatory actions regarding the safety of biologics. ArticleCASPubMed Google Scholar
Zink, A. et al. European biologicals registers: methodology, selected results and perspectives. Ann. Rheum. Dis.68, 1240–1246 (2009). ArticleCASPubMed Google Scholar
Lutterotti, A. & Martin, R. Getting specific: monoclonal antibodies in multiple sclerosis. Lancet Neurol.7, 538–547 (2008). ArticleCASPubMed Google Scholar
Yeung, Y. A. et al. Engineering human IgG1 affinity to human neonatal Fc receptor: impact of affinity improvement on pharmacokinetics in primates. J. Immunol.182, 7663–7671 (2009). ArticleCASPubMed Google Scholar
Chang, T. W. Developing antibodies for targeting immunoglobulin and membrane-bound immunoglobulin E. Allergy Asthma Proc.27, S7–S14 (2006). CASPubMed Google Scholar
Hassan, M. S., bedi-Valugerdi, M., Lefranc, G., Hammarstrom, L. & Smith, C. I. Biological half-life of normal and truncated human IgG3 in SCID mice. Eur. J. Immunol.21, 1319–1322 (1991). ArticleCASPubMed Google Scholar
Jefferis, R. Recombinant antibody therapeutics: the impact of glycosylation on mechanisms of action. Trends Pharmacol. Sci.30, 356–362 (2009). ArticleCASPubMed Google Scholar
Holland, M. et al. Anti-neutrophil cytoplasm antibody IgG subclasses in Wegener's granulomatosis: a possible pathogenic role for the IgG4 subclass. Clin. Exp. Immunol.138, 183–192 (2004). ArticleCASPubMedPubMed Central Google Scholar
van der Neut Kolfschoten, M. et al. Anti-inflammatory activity of human IgG4 antibodies by dynamic Fab arm exchange. Science317, 1554–1557 (2007). ArticleCAS Google Scholar
Tabrizi, M. A. & Roskos, L. K. Preclinical and clinical safety of monoclonal antibodies. Drug Discov. Today12, 540–547 (2007). ArticleCASPubMed Google Scholar
Cavagnaro, J. A. (ed.) Preclinical Safety Evaluation of Biopharmaceuticals: A Science Based Approach to Facilitating Clinical Trials (Wiley, London, 2008). A recent book on preclinical safety testing of biopharmaceuticals. Book Google Scholar
Longstaff, C., Whitton, C. M., Stebbings, R. & Gray, E. How do we assure the quality of biological medicines? Drug Discov. Today14, 50–55 (2009). ArticleCASPubMed Google Scholar
Loisel, S. et al. Relevance, advantages and limitations of animal models used in the development of monoclonal antibodies for cancer treatment. Crit. Rev. Oncol. Hematol.62, 34–42 (2007). ArticlePubMed Google Scholar
Chapman, K., Pullen, N., Graham, M. & Ragan, I. Preclinical safety testing of monoclonal antibodies: the significance of species relevance. Nature Rev. Drug Discov.6, 120–126 (2007). ArticleCAS Google Scholar
Presta, L. G. Engineering of therapeutic antibodies to minimize immunogenicity and optimize function. Adv. Drug Deliv. Rev.58, 640–656 (2006). ArticleCASPubMed Google Scholar
Chung, C. H. Managing premedications and the risk for reactions to infusional monoclonal antibody therapy. Oncologist13, 725–732 (2008). ArticleCASPubMed Google Scholar
Klastersky, J. Adverse effects of the humanized antibodies used as cancer therapeutics. Curr. Opin. Oncol.18, 316–320 (2006). ArticleCASPubMed Google Scholar
Kang, S. P. & Saif, M. W. Infusion-related and hypersensitivity reactions of monoclonal antibodies used to treat colorectal cancer — identification, prevention, and management. J. Support. Oncol.5, 451–457 (2007). CASPubMed Google Scholar
Lenz, H. J. Management and preparedness for infusion and hypersensitivity reactions. Oncologist12, 601–609 (2007). ArticleCASPubMed Google Scholar
Coiffier, B. et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N. Engl. J. Med.346, 235–242 (2002). ArticleCASPubMed Google Scholar
Chung, C. H. et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N. Engl. J. Med.358, 1109–1117 (2008). ArticleCASPubMedPubMed Central Google Scholar
Poole, J. A., Matangkasombut, P. & Rosenwasser, L. J. Targeting the IgE molecule in allergic and asthmatic diseases: review of the IgE molecule and clinical efficacy. J. Allergy Clin. Immunol.115, S376–S385 (2005). ArticlePubMed Google Scholar
Gould, H. J. & Sutton, B. J. IgE in allergy and asthma today. Nature Rev. Immunol.8, 205–217 (2008). ArticleCAS Google Scholar
Cox, L. et al. American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma and Immunology Joint Task Force Report on omalizumab-associated anaphylaxis. J. Allergy Clin. Immunol.120, 1373–1377 (2007). ArticleCASPubMed Google Scholar
Corren, J. et al. Safety and tolerability of omalizumab. Clin. Exp. Allergy39, 788–797 (2009). ArticleCASPubMed Google Scholar
Limb, S. L., Starke, P. R., Lee, C. E. & Chowdhury, B. A. Delayed onset and protracted progression of anaphylaxis after omalizumab administration in patients with asthma. J. Allergy Clin. Immunol.120, 1378–1381 (2007). ArticleCASPubMed Google Scholar
Carter, P. Improving the efficacy of antibody-based cancer therapies. Naure Rev. Cancer1, 118–129 (2001). ArticleCAS Google Scholar
Loertscher, R. The utility of monoclonal antibody therapy in renal transplantation. Transplant. Proc.34, 797–800 (2002). ArticleCASPubMed Google Scholar
Gaston, R. S. et al. OKT3 first-dose reaction: association with T cell subsets and cytokine release. Kidney Int.39, 141–148 (1991). ArticleCASPubMed Google Scholar
Kuus-Reichel, K. et al. Will immunogenicity limit the use, efficacy, and future development of therapeutic monoclonal antibodies? Clin. Diagn. Lab. Immunol.1, 365–372 (1994). ArticleCASPubMedPubMed Central Google Scholar
Mascelli, M. A. et al. Molecular, biologic, and pharmacokinetic properties of monoclonal antibodies: impact of these parameters on early clinical development. J. Clin. Pharmacol.47, 553–565 (2007). ArticleCASPubMed Google Scholar
Carter, P. J. Potent antibody therapeutics by design. Nature Rev. Immunol.6, 343–357 (2006). ArticleCAS Google Scholar
Azinovic, I. et al. Survival benefit associated with human anti-mouse antibody (HAMA) in patients with B-cell malignancies. Cancer Immunol. Immunother.55, 1451–1458 (2006). ArticleCASPubMed Google Scholar
Clark, M. Antibody humanization: a case of the 'Emperor's new clothes'? Immunol. Today21, 397–402 (2000). ArticleCASPubMed Google Scholar
Cohen, B. A., Oger, J., Gagnon, A. & Giovannoni, G. The implications of immunogenicity for protein-based multiple sclerosis therapies. J. Neurol. Sci.275, 7–17 (2008). ArticleCASPubMed Google Scholar
Schellekens, H. Factors influencing the immunogenicity of therapeutic proteins. Nephrol. Dial. Transplant.20 (Suppl. 6), vi3–vi9 (2005). ArticleCASPubMed Google Scholar
Todd, D. J. & Helfgott, S. M. Serum sickness following treatment with rituximab. J. Rheumatol.34, 430–433 (2007). PubMed Google Scholar
Schellekens, H., Crommein, D. & Jiskoot, W. in Handbook of Therapeutic Antibodies Vol. 1 Ch. 11 (ed. Dubel, S.) (Wiley, Weinheim, 2007). Google Scholar
Shankar, G., Shores, E., Wagner, C. & Mire-Sluis, A. Scientific and regulatory considerations on the immunogenicity of biologics. Trends Biotechnol.24, 274–280 (2006). ArticleCASPubMed Google Scholar
Aarden, L., Ruuls, S. R. & Wolbink, G. Immunogenicity of anti-tumor necrosis factor antibodies-toward improved methods of anti-antibody measurement. Curr. Opin. Immunol.20, 431–435 (2008). ArticleCASPubMed Google Scholar
European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. Doc. Ref. EMEA/CHMP/BMWP/14327/2006. EMA website [online], (2007).
European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. Doc. Ref. EMEA/CHMP/BMWP/114720/2009. EMA website [online], (2009). Recent EMA guidelines on immunogenicity testing of mAbs.
Coiffier, B., Altman, A., Pui, C. H., Younes, A. & Cairo, M. S. Guidelines for the management of pediatric and adult tumor lysis syndrome: an evidence-based review. J. Clin. Oncol.26, 2767–2778 (2008). ArticleCASPubMed Google Scholar
Tosi, P. et al. Consensus conference on the management of tumor lysis syndrome. Haematologica93, 1877–1185 (2008). ArticlePubMed Google Scholar
Otrock, Z. K., Hatoum, H. A. & Salem, Z. M. Acute tumor lysis syndrome after rituximab administration in Burkitt's lymphoma. Intern. Emerg. Med.3, 161–163 (2008). ArticlePubMed Google Scholar
Feusner, J. H., Ritchey, A. K., Cohn, S. L. & Billett, A. L. Management of tumor lysis syndrome: need for evidence-based guidelines. J. Clin. Oncol.26, 5657–5658 (2008). ArticlePubMed Google Scholar
Taylor, P. C. & Feldmann, M. Anti-TNF biologic agents: still the therapy of choice for rheumatoid arthritis. Nature Rev. Rheumatol.5, 578–582 (2009). ArticleCAS Google Scholar
Feldmann, M. & Maini, S. R. Role of cytokines in rheumatoid arthritis: an education in pathophysiology and therapeutics. Immunol. Rev.223, 7–19 (2008). ArticleCASPubMed Google Scholar
Moss, M. L., Sklair-Tavron, L. & Nudelman, R. Drug insight: tumor necrosis factor-converting enzyme as a pharmaceutical target for rheumatoid arthritis. Nature Clin. Pract. Rheumatol.4, 300–309 (2008). ArticleCAS Google Scholar
Keane, J. TNF-blocking agents and tuberculosis: new drugs illuminate an old topic. Rheumatology44, 714–720 (2005). ArticleCASPubMed Google Scholar
Askling, J. et al. Risk and case characteristics of tuberculosis in rheumatoid arthritis associated with tumor necrosis factor antagonists in Sweden. Arthritis Rheum.52, 1986–1992 (2005). ArticleCASPubMed Google Scholar
Bongartz, T. 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. JAMA295, 2275–2285 (2006). ArticleCASPubMed Google Scholar
Schneeweiss, S. et al. Anti-tumor necrosis factor alpha therapy and the risk of serious bacterial infections in elderly patients with rheumatoid arthritis. Arthritis Rheum.56, 1754–1764 (2007). ArticleCASPubMed Google Scholar
Theis, V. S. & Rhodes, J. M. Review article: minimizing tuberculosis during anti-tumour necrosis factor-alpha treatment of inflammatory bowel disease. Aliment. Pharmacol. Ther.27, 19–30 (2008). ArticleCASPubMed Google Scholar
Colombel, J. F. et al. The safety profile of infliximab in patients with Crohn's disease: the Mayo clinic experience in 500 patients. Gastroenterology126, 19–31 (2004). ArticleCASPubMed Google Scholar
British Thoracic Society Standards of Care Committee. BTS recommendations for assessing risk and for managing Mycobacterium tuberculosis infection and disease in patients due to start anti-TNF-α treatment. Thorax60, 800–805 (2005).
Major, E. O. Progressive multifocal leukoencephalopathy in patients on immunomodulatory therapies. Annu. Rev. Med.61, 35–47 (2010). ArticleCASPubMed Google Scholar
Carson, K. R. et al. Monoclonal antibody-associated progressive multifocal leucoencephalopathy in patients treated with rituximab, natalizumab, and efalizumab: a Review from the Research on Adverse Drug Events and Reports (RADAR) project. Lancet Oncol.10, 816–824 (2009). ArticleCASPubMed Google Scholar
Lopez-Diego, R. S. & Weiner, H. L. Novel therapeutic strategies for multiple sclerosis — a multifaceted adversary. Nature Rev. Drug Discov.7, 909–925 (2008). ArticleCAS Google Scholar
Sadiq, S. A., Puccio, L. M. & Brydon, E. W. JCV detection in multiple sclerosis patients treated with natalizumab. J. Neurol. 7 Jan 2010 (doi:10.1007/s00415-009-5444-4). ArticleCASPubMed Google Scholar
Major, E. O. Reemergence of PML in natalizumab-treated patients — new cases, same concerns. N. Engl. J. Med.361, 1041–1043 (2009). ArticleCASPubMed Google Scholar
Kleinschmidt-DeMasters, B. K. & Tyler, K. L. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon β-1a for multiple sclerosis. N. Engl. J. Med.353, 369–374 (2005). ArticleCASPubMed Google Scholar
Langer-Gould, A., Atlas, S. W., Green, A. J., Bollen, A. W. & Pelletier, D. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N. Engl. J. Med.353, 375–381 (2005). ArticleCASPubMed Google Scholar
Van Assche, G. et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn's disease. N. Engl. J. Med.353, 362–368 (2005). References 77–79 are the original descriptions of cases of PML with natalizumab. ArticleCASPubMed Google Scholar
Wenning, W. et al. Treatment of progressive multifocal leukoencephalopathy associated with natalizumab. N. Engl. J. Med.361, 1075–1080 (2009). ArticleCASPubMed Google Scholar
Linda, H. et al. Progressive multifocal leukoencephalopathy after natalizumab monotherapy. N. Engl. J. Med.361, 1081–1087 (2009). References 80 and 81 are recent descriptions of cases of PML with natalizumab. ArticleCASPubMed Google Scholar
Yousry, T. A. et al. Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy. N. Engl. J. Med.354, 924–933 (2006). ArticleCASPubMedPubMed Central Google Scholar
Kappos, L. et al. Natalizumab treatment for multiple sclerosis: recommendations for patient selection and monitoring. Lancet Neurol.6, 431–441 (2007). ArticlePubMed Google Scholar
Landry, M. L., Eid, T., Bannykh, S. & Major, E. False negative PCR despite high levels of JC virus DNA in spinal fluid: implications for diagnostic testing. J. Clin. Virol.43, 247–249 (2008). ArticleCASPubMedPubMed Central Google Scholar
Chen, Y. et al. Asymptomatic reactivation of JC virus in patients treated with natalizumab. N. Engl. J. Med.361, 1067–1074 (2009).Documentation that reactivation of JCV occurs commonly with natalizumab therapy in multiple sclerosis. ArticleCASPubMedPubMed Central Google Scholar
Delbue, S., Tremolada, S. & Ferrante, P. Application of molecular tools for the diagnosis of central nervous system infections. Neurol. Sci.29 (Suppl. 2), 283–285 (2008). Article Google Scholar
Molloy, E. S. & Calabrese, L. H. Therapy: targeted but not trouble-free: efalizumab and PML. Nature Rev. Rheumatol.5, 418–419 (2009). ArticleCAS Google Scholar
Bonig, H., Wundes, A., Chang, K. H., Lucas, S. & Papayannopoulou, T. Increased numbers of circulating hematopoietic stem/progenitor cells are chronically maintained in patients treated with the CD49d blocking antibody natalizumab. Blood111, 3439–3441 (2008). ArticleCASPubMedPubMed Central Google Scholar
Zohren, F. et al. The monoclonal anti-VLA-4 antibody natalizumab mobilizes CD34+ hematopoietic progenitor cells in humans. Blood111, 3893–3895 (2008). ArticleCASPubMed Google Scholar
Aksoy, S. et al. Rituximab-related viral infections in lymphoma patients. Leuk. Lymphoma48, 1307–1312 (2007). ArticleCASPubMed Google Scholar
Carson, K. R. 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. Blood113, 4834–4840 (2009). ArticleCASPubMedPubMed Central Google Scholar
Aster, R. H. & Bougie, D. W. Drug-induced immune thrombocytopenia. N. Engl. J. Med.357, 580–587 (2007). ArticlePubMed Google Scholar
Topol, E. J., Byzova, T. V. & Plow, E. F. Platelet GPIIb-IIIa blockers. Lancet353, 227–231 (1999). ArticleCASPubMed Google Scholar
Tcheng, J. E. et al. Abciximab readministration: results of the ReoPro Readministration Registry. Circulation104, 870–875 (2001). ArticleCASPubMed Google Scholar
Topol, E. J. et al. Multi-year follow-up of abciximab therapy in three randomized, placebo-controlled trials of percutaneous coronary revascularization. Am. J. Med.113, 1–6 (2002). ArticleCASPubMed Google Scholar
Tamhane, U. U. & Gurm, H. S. The chimeric monoclonal antibody abciximab: a systematic review of its safety in contemporary practice. Expert Opin. Drug Saf.7, 809–819 (2008). ArticleCASPubMed Google Scholar
Curtis, B. R., Divgi, A., Garritty, M. & Aster, R. H. Delayed thrombocytopenia after treatment with abciximab: a distinct clinical entity associated with the immune response to the drug. J. Thromb. Haemost.2, 985–992 (2004). ArticleCASPubMed Google Scholar
Curtis, B. R., Swyers, J., Divgi, A., McFarland, J. G. & Aster, R. H. Thrombocytopenia after second exposure to abciximab is caused by antibodies that recognize abciximab-coated platelets. Blood99, 2054–2059 (2002). ArticleCASPubMed Google Scholar
McCorry, R. B. & Johnston, P. Fatal delayed thrombocytopenia following abciximab therapy. J. Invasive Cardiol.18, E173–E174 (2006). PubMed Google Scholar
Mukherjee, D. & Roffi, M. Glycoprotein IIb/IIIa receptor inhibitors in 2008: do they still have a role? J. Interv. Cardiol.21, 118–121 (2008). ArticlePubMed Google Scholar
Cox, A. L. et al. Lymphocyte homeostasis following therapeutic lymphocyte depletion in multiple sclerosis. Eur. J. Immunol.35, 3332–3342 (2005). ArticleCASPubMed Google Scholar
Lorenzi, A. R. et al. Morbidity and mortality in rheumatoid arthritis patients with prolonged therapy-induced lymphopenia: twelve-year outcomes. Arthritis Rheum.58, 370–375 (2008). ArticlePubMed Google Scholar
Chakrabarti, S. et al. T-cell depletion with Campath-1H “in the bag” for matched related allogeneic peripheral blood stem cell transplantation is associated with reduced graft-versus-host disease, rapid immune constitution and improved survival. Br. J. Haematol.121, 109–118 (2003). ArticlePubMed Google Scholar
Hale, G. et al. CD52 antibodies for prevention of graft-versus-host disease and graft rejection following transplantation of allogeneic peripheral blood stem cells. Bone Marrow Transplant.26, 69–76 (2000). ArticleCASPubMed Google Scholar
Lin, T. S. Novel agents in chronic lymphocytic leukemia: efficacy and tolerability of new therapies. Clin. Lymphoma Myeloma.8 (Suppl. 4), 137–143 (2008). ArticleCAS Google Scholar
Watson, C. J. et al. Alemtuzumab (CAMPATH 1H) induction therapy in cadaveric kidney transplantation — efficacy and safety at five years. Am. J. Transplant.5, 1347–1353 (2005). ArticleCASPubMed Google Scholar
Coles, A. J. et al. Alemtuzumab vs. interferon β-1a in early multiple sclerosis. N. Engl. J. Med.359, 1786–1801 (2008). ArticlePubMed Google Scholar
Hauser, S. L. Multiple lessons for multiple sclerosis. N. Engl. J. Med.359, 1838–1841 (2008). ArticleCASPubMed Google Scholar
Haider, I. & Cahill, M. Fatal thrombocytopaenia temporally related to the administration of alemtuzumab (MabCampath) for refractory CLL despite early discontinuation of therapy. Hematology9, 409–411 (2004). ArticleCASPubMed Google Scholar
Gibbs, S. D., Westerman, D. A., McCormack, C., Seymour, J. F. & Miles, P. H. Severe and prolonged myeloid haematopoietic toxicity with myelodysplastic features following alemtuzumab therapy in patients with peripheral T-cell lymphoproliferative disorders. Br. J. Haematol.130, 87–91 (2005). ArticleCASPubMed Google Scholar
Patel, V. L., Schwartz, J. & Bussel, J. B. The effect of anti-CD40 ligand in immune thrombocytopenic purpura. Br. J. Haematol.141, 545–548 (2008). ArticleCASPubMed Google Scholar
Koyama, I. et al. Thrombophilia associated with anti-CD154 monoclonal antibody treatment and its prophylaxis in nonhuman primates. Transplantation77, 460–462 (2004). ArticleCASPubMed Google Scholar
Kawai, T., Andrews, D., Colvin, R. B., Sachs, D. H. & Cosimi, A. B. Letters to the Editor: Thromboembolic complications after treatment with monoclonal antibody against CD49 ligand. Nature Med.6, 114 (2000). ArticleCASPubMed Google Scholar
Kirk, A. D. & Harlan, D. M. Letters to the Editor: Thromboembolic complications after treatment with monoclonal antibody against CD40 ligand. Nature Med.6, 114 (2000). ArticleCAS Google Scholar
Mirabet, M., Barrabes, J. A., Quiroga, A. & Garcia-Dorado, D. Platelet pro-aggregatory effects of CD40L monoclonal antibody. Mol. Immunol.45, 937–944 (2008). ArticleCASPubMed Google Scholar
Langer, F. et al. The role of CD40 in CD40L- and antibody-mediated platelet activation. Thromb. Haemost.93, 1137–1146 (2005). ArticleCASPubMed Google Scholar
Scappaticci, F. A. et al. Arterial thromboembolic events in patients with metastatic carcinoma treated with chemotherapy and bevacizumab. J. Natl Cancer Inst.99, 1232–1239 (2007). ArticlePubMed Google Scholar
Nalluri, S. R., Chu, D., Keresztes, R., Zhu, X. & Wu, S. Risk of venous thromboembolism with the angiogenesis inhibitor bevacizumab in cancer patients: a meta-analysis. JAMA300, 2277–2285 (2008). ArticleCASPubMed Google Scholar
Mongey, A. B. & Hess, E. V. Drug insight: autoimmune effects of medications — what's new? Nature Clin. Pract. Rheumatol.4, 136–144 (2008). ArticleCAS Google Scholar
Ramos-Casals, M. et al. Autoimmune diseases induced by TNF-targeted therapies: analysis of 233 cases. Medicine86, 242–251 (2007). ArticlePubMed Google Scholar
Haraoui, B. & Keystone, E. Musculoskeletal manifestations and autoimmune diseases related to new biologic agents. Curr. Opin. Rheumatol.18, 96–100 (2006). ArticlePubMed Google Scholar
Coles, A. J. et al. Pulsed monoclonal antibody treatment and autoimmune thyroid disease in multiple sclerosis. Lancet354, 1691–1695 (1999). ArticleCASPubMed Google Scholar
Fong, L. & Small, E. J. Anti-cytotoxic T-lymphocyte antigen-4 antibody: the first in an emerging class of immunomodulatory antibodies for cancer treatment. J. Clin. Oncol.26, 5275–5283 (2008). ArticleCASPubMed Google Scholar
Maker, A. V., Attia, P. & Rosenberg, S. A. Analysis of the cellular mechanism of antitumor responses and autoimmunity in patients treated with CTLA-4 blockade. J. Immunol.175, 7746–7754 (2005). ArticleCASPubMed Google Scholar
Peggs, K. S., Quezada, S. A., Korman, A. J. & Allison, J. P. Principles and use of anti-CTLA4 antibody in human cancer immunotherapy. Curr. Opin. Immunol.18, 206–213 (2006). ArticleCASPubMed Google Scholar
Weber, J. Review: anti-CTLA-4 antibody ipilimumab: case studies of clinical response and immune-related adverse events. Oncologist12, 864–872 (2007). ArticleCASPubMed Google Scholar
Kaufman, H. L. & Wolchok, J. D. Is tumor immunity the same thing as autoimmunity? Implications for cancer immunotherapy. J. Clin. Oncol.24, 2230–2232 (2006). ArticleCASPubMed Google Scholar
Askling, J. & Bongartz, T. Malignancy and biologic therapy in rheumatoid arthritis. Curr. Opin. Rheumatol.20, 334–339 (2008). ArticleCASPubMed Google Scholar
Scott, D. L. & Kingsley, G. H. Tumor necrosis factor inhibitors for rheumatoid arthritis. N. Engl. J. Med.355, 704–712 (2006). ArticleCASPubMed Google Scholar
Dixon, W. & Silman, A. Is there an association between anti-TNF monoclonal antibody therapy in rheumatoid arthritis and risk of malignancy and serious infection? Commentary on the meta-analysis by Bongartz. et al. Arthritis Res. Ther.8, 111 (2006). ArticlePubMedPubMed CentralCAS Google Scholar
Askling, J. et al. Risks of solid cancers in patients with rheumatoid arthritis and after treatment with tumour necrosis factor antagonists. Ann. Rheum. Dis.64, 1421–1426 (2005). ArticleCASPubMedPubMed Central Google Scholar
Setoguchi, S. et al. Tumor necrosis factor alpha antagonist use and cancer in patients with rheumatoid arthritis. Arthritis Rheum.54, 2757–2764 (2006). ArticleCASPubMed Google Scholar
Biancone, L., Calabrese, E., Petruzziello, C. & Pallone, F. Treatment with biologic therapies and the risk of cancer in patients with IBD. Nature Clin. Pract. Gastroenterol. Hepatol.4, 78–91 (2007). ArticleCAS Google Scholar
Rennard, S. I. et al. The safety and efficacy of infliximab in moderate-to-severe chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care Med.175, 926–934 (2007). ArticleCASPubMed Google Scholar
Rosh, J. R., Gross, T., Mamula, P., Griffiths, A. & Hyams, J. Hepatosplenic T-cell lymphoma in adolescents and young adults with Crohn's disease: a cautionary tale? Inflamm. Bowel Dis.13, 1024–1030 (2007). ArticlePubMed Google Scholar
Krueger, G. G. et al. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N. Engl. J. Med.356, 580–592 (2007). ArticleCASPubMed Google Scholar
Sandborn, W. J. Current directions in IBD therapy: what goals are feasible with biological modifiers? Gastroenterology135, 1442–1447 (2008). ArticlePubMed Google Scholar
Segal, B. M. et al. Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing–remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study. Lancet Neurol.7, 796–804 (2008). ArticleCASPubMed Google Scholar
Weiss, J. M., Subleski, J. J., Wigginton, J. M. & Wiltrout, R. H. Immunotherapy of cancer by IL-12-based cytokine combinations. Expert. Opin. Biol. Ther.7, 1705–1721 (2007). ArticleCASPubMedPubMed Central Google Scholar
Langowski, J. L. et al. IL-23 promotes tumour incidence and growth. Nature442, 461–465 (2006). ArticleCASPubMed Google Scholar
Knox, S. J. et al. Yttrium-90-labeled anti-CD20 monoclonal antibody therapy of recurrent B-cell lymphoma. Clin. Cancer Res.2, 457–470 (1996). CASPubMed Google Scholar
Witzig, T. E. et al. Long-term responses in patients with recurring or refractory B-cell non-Hodgkin lymphoma treated with yttrium 90 ibritumomab tiuxetan. Cancer109, 1804–1810 (2007). ArticleCASPubMed Google Scholar
Jean, G. W. & Shah, S. R. Epidermal growth factor receptor monoclonal antibodies for the treatment of metastatic colorectal cancer. Pharmacotherapy28, 742–754 (2008). ArticleCASPubMed Google Scholar
Perez-Soler, R. & Saltz, L. Cutaneous adverse effects with HER1/EGFR-targeted agents: is there a silver lining? J. Clin. Oncol.23, 5235–5246 (2005). ArticlePubMed Google Scholar
Bianchini, D., Jayanth, A., Chua, Y. J. & Cunningham, D. Epidermal growth factor receptor inhibitor-related skin toxicity: mechanisms, treatment, and its potential role as a predictive marker. Clin. Colorectal Cancer7, 33–43 (2008). ArticleCASPubMed Google Scholar
Saif, M. W., Longo, W. L. & Israel, G. Correlation between rash and a positive drug response associated with bevacizumab in a patient with advanced colorectal cancer. Clin. Colorectal Cancer7, 144–148 (2008). ArticleCASPubMed Google Scholar
Bauer, K. A., Hammerman, S., Rapoport, B. & Lacouture, M. E. Completeness in the reporting of dermatologic adverse drug reactions associated with monoclonal antibody epidermal growth factor receptor inhibitors in phase II and III colorectal cancer clinical trials. Clin. Colorectal Cancer7, 309–314 (2008). ArticlePubMed Google Scholar
Bernier, J. et al. Consensus guidelines for the management of radiation dermatitis and coexisting acne-like rash in patients receiving radiotherapy plus EGFR inhibitors for the treatment of squamous cell carcinoma of the head and neck. Ann. Oncol.19, 142–149 (2008). ArticleCASPubMed Google Scholar
Scope, A. et al. Randomized double-blind trial of prophylactic oral minocycline and topical tazarotene for cetuximab-associated acne-like eruption. J. Clin. Oncol.25, 5390–5396 (2007). ArticleCASPubMed Google Scholar
Hudis, C. A. Trastuzumab — mechanism of action and use in clinical practice. N. Engl. J. Med.357, 39–51 (2007). ArticleCASPubMed Google Scholar
Force, T., Krause, D. S. & Van Etten, R. A. Molecular mechanisms of cardiotoxicity of tyrosine kinase inhibition. Nature Rev. Cancer7, 332–344 (2007). ArticleCAS Google Scholar
Guglin, M., Cutro, R. & Mishkin, J. D. Trastuzumab-induced cardiomyopathy. J. Card. Fail.14, 437–444 (2008). ArticleCASPubMed Google Scholar
Klein, P. M. & Dybdal, N. Trastuzumab and cardiac dysfunction: update on preclinical studies. Semin. Oncol.30, 49–53 (2003). ArticleCASPubMed Google Scholar
Perez, E. A. Cardiac toxicity of ErbB2-targeted therapies: what do we know? Clin. Breast Cancer8 (Suppl. 3), 114–120 (2008). Article Google Scholar
Chien, K. R. Herceptin and the heart — a molecular modifier of cardiac failure. N. Engl. J. Med.354, 789–790 (2006). ArticleCASPubMed Google Scholar
Joensuu, H. et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N. Engl. J. Med.354, 809–820 (2006). ArticleCASPubMed Google Scholar
Force, T. & Kerkela, R. Cardiotoxicity of the new cancer therapeutics — mechanisms of, and approaches to, the problem. Drug Discov. Today13, 778–784 (2008). ArticleCASPubMedPubMed Central Google Scholar
Chen, M. H., Kerkela, R. & Force, T. Mechanisms of cardiac dysfunction associated with tyrosine kinase inhibitor cancer therapeutics. Circulation117, 84–95 (2008). Article Google Scholar
Crone, S. A. et al. ErbB2 is essential in the prevention of dilated cardiomyopathy. Nature Med.8, 459–465 (2002). ArticleCASPubMed Google Scholar
Kuramochi, Y., Guo, X. & Sawyer, D. B. Neuregulin activates erbB2-dependent src/FAK signaling and cytoskeletal remodeling in isolated adult rat cardiac myocytes. J. Mol. Cell Cardiol.41, 228–235 (2006). ArticleCASPubMedPubMed Central Google Scholar
Grazette, L. P. et al. Inhibition of ErbB2 causes mitochondrial dysfunction in cardiomyocytes: implications for herceptin-induced cardiomyopathy. J. Am. Coll. Cardiol.44, 2231–2238 (2004). ArticleCASPubMed Google Scholar
Lemmens, K., Doggen, K. & Keulenaer, G. W. Neuregulin-1 and its potential role in the control of cardiac function. Heart Fail. Monit.5, 119–124 (2008). CASPubMed Google Scholar
Wing, M. Monoclonal antibody first dose cytokine release syndromes — mechanisms and prediction. J. Immunotoxicol.5, 11–15 (2008). ArticleCASPubMed Google Scholar
Plevy, S. et al. A Phase I study of visilzumab, a humanised anti-CD3 monoclonal antibody, in severe steroid-refractory ulcerative colitis. Gastroenterology133, 1414–1422 (2007). ArticleCASPubMed Google Scholar
Wing, M. G., Waldmann, H., Isaacs, J., Compston, D. A. & Hale, G. Ex-vivo whole blood cultures for predicting cytokine-release syndrome: dependence on target antigen and antibody isotype. Ther. Immunol.2, 183–190 (1995). CASPubMed Google Scholar
Wing, M. G. et al. Mechanism of first-dose cytokine-release syndrome by CAMPATH 1-H: involvement of CD16 (FcgammaRIII) and CD11a/CD18 (LFA-1) on NK cells. J. Clin. Invest.98, 2819–2826 (1996). ArticleCASPubMedPubMed Central Google Scholar
Winkler, U. et al. Cytokine-release syndrome in patients with B-cell chronic lymphocytic leukemia and high lymphocyte counts after treatment with an anti-CD20 monoclonal antibody (rituximab, IDEC-C2B8). Blood94, 2217–2224 (1999). ArticleCASPubMed Google Scholar
Suntharalingam, G. et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N. Engl. J. Med.355, 1018–1028 (2006). A detailed description of the laboratory events and clinical course after administration of TGN1412 to healthy volunteers: the cytokine storm. ArticleCAS Google Scholar
Kenter, M. J. & Cohen, A. F. Establishing risk of human experimentation with drugs: lessons from TGN1412. Lancet368, 1387–1391 (2006). ArticleCASPubMed Google Scholar
Expert Group on Phase One Clinical Trials (Chairman: Professor Gordon W.Duff) Expert Scientific Group on Phase One Clinical Trials: Final Report (The Stationery Office, Norwich, UK, 2006). Report of a UK Expert Group commenting on safety of Phase I studies in the light of the TGN1412 cytokine storm.
Association of the British Pharmaceutical Industry (ABPI), BioIndustry Association (BIA).Early Stage Clinical Trial Taskforce — Joint ABPI/BIA Report. ABPI website [online], (2006).
Muller, P. Y., Milton, M., Lloyd, P., Sims, J. & Brennan, F. R. The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies. Curr. Opin. Biotechnol.20, 722–729 (2009). ArticleCASPubMed Google Scholar
Beyersdorf, N., Hanke, T., Kerkau, T. & Hunig, T. Superagonistic anti-CD28 antibodies: potent activators of regulatory T cells for the therapy of autoimmune diseases. Ann. Rheum. Dis.64 (Suppl. 4), iv91–iv95 (2005). CASPubMedPubMed Central Google Scholar
Beyersdorf, N. et al. Selective targeting of regulatory T cells with CD28 superagonists allows effective therapy of experimental autoimmune encephalomyelitis. J. Exp. Med.202, 445–455 (2005). ArticleCASPubMedPubMed Central Google Scholar
Hunig, T. & Dennehy, K. CD28 superagonists: mode of action and therapeutic potential. Immunol. Lett.100, 21–28 (2005). ArticlePubMedCAS Google Scholar
Muller, N. et al. A CD28 superagonistic antibody elicits 2 functionally distinct waves of T cell activation in rats. J. Clin. Invest.118, 1405–1416 (2008). ArticlePubMedPubMed CentralCAS Google Scholar
Hunig, T. Manipulation of regulatory T-cell number and function with CD28-specific monoclonal antibodies. Adv. Immunol.95, 111–148 (2007). ArticlePubMedCAS Google Scholar
Schraven, B. & Kalinke, U. CD28 superagonists: what makes the difference in humans? Immunity28, 591–595 (2008). ArticleCASPubMed Google Scholar
Liu, E. H., Siegel, R. M., Harlan, D. M. & O'Shea, J. J. T cell-directed therapies: lessons learned and future prospects. Nature Immunol.8, 25–30 (2007). ArticleCAS Google Scholar
Sharpe, A. H. & Abbas, A. K. T-cell costimulation-biology, therapeutic potential, and challenges. N. Engl. J. Med.355, 973–975 (2006). ArticleCASPubMed Google Scholar
Dayan, C. M. & Wraith, D. C. Preparing for first-in-man studies: the challenges for translational immunology post-TGN1412. Clin. Exp. Immunol.151, 231–234 (2008). ArticleCASPubMedPubMed Central Google Scholar
Ohresser, M., Olive, D., Vanhove, B. & Watier, H. Risk in drug trials. Lancet368, 2205–2206 (2006). ArticlePubMed Google Scholar
Waibler, Z. et al. Signaling signatures and functional properties of anti-human CD28 superagonistic antibodies. PLoS ONE3, e1708 (2008). In vitrostudies on human blood cell signalling with superagonist human CD28-specific mAbs. ArticlePubMedPubMed CentralCAS Google Scholar
Mehrishi, J. N., Szabo, M. & Bakacs, T. Some aspects of the recombinantly expressed humanised superagonist anti-CD28 mAb, TGN1412 trial catastrophe lessons to safeguard mAbs and vaccine trials. Vaccine25, 3517–3523 (2007). ArticleCASPubMed Google Scholar
Yokosuka, T. & Saito, T. Dynamic regulation of T-cell costimulation through TCR-CD28 microclusters. Immunol. Rev.229, 27–40 (2009). ArticleCASPubMed Google Scholar
Buysmann, S. et al. Activation and increased expression of adhesion molecules on peripheral blood lymphocytes is a mechanism for the immediate lymphocytopenia after administration of OKT3. Blood87, 404–411 (1996). ArticleCASPubMed Google Scholar
Mourad, G. J. et al. Humanized IgG1 and IgG4 anti-CD4 monoclonal antibodies: effects on lymphocytes in the blood, lymph nodes, and renal allografts in cynomolgus monkeys. Transplantation65, 632–641 (1998). ArticleCASPubMed Google Scholar
Hernandez-Caselles, T. et al. A study of CD33 (SIGLEC-3) antigen expression and function on activated human T and NK cells: two isoforms of CD33 are generated by alternative splicing. J. Leukoc. Biol.79, 46–58 (2006). ArticleCASPubMed Google Scholar
Nguyen, D. H., Hurtado-Ziola, N., Gagneux, P. & Varki, A. Loss of Siglec expression on T lymphocytes during human evolution. Proc. Natl Acad. Sci. USA103, 7765–7770 (2006). ArticleCASPubMedPubMed Central Google Scholar
Isaacs, J. D. et al. A therapeutic human IgG4 monoclonal antibody that depletes target cells in humans. Clin. Exp. Immunol.106, 427–433 (1996). ArticleCASPubMedPubMed Central Google Scholar
Avril, T., Attrill, H., Zhang, J., Raper, A. & Crocker, P. R. Negative regulation of leucocyte functions by CD33-related siglecs. Biochem. Soc. Trans.34, 1024–1027 (2006). ArticleCASPubMed Google Scholar
Crocker, P. R., Paulson, J. C. & Varki, A. Siglecs and their roles in the immune system. Nature Rev. Immunol.7, 255–266 (2007). ArticleCAS Google Scholar
Crocker, P. R. & Redelinghuys, P. Siglecs as positive and negative regulators of the immune system. Biochem. Soc. Trans.36, 1467–1471 (2008). ArticleCASPubMed Google Scholar
Gogishvili, T. et al. Rapid regulatory T-cell response prevents cytokine storm in CD28 superagonist treated mice. PLoS ONE4, e4643 (2009). ArticlePubMedPubMed CentralCAS Google Scholar
Perruche, S. et al. Lethal effect of CD3-specific antibody in mice deficient in TGF-β1 by uncontrolled flu-like syndrome. J. Immunol.183, 953–961 (2009). ArticleCASPubMed Google Scholar
Muller, P. Y. & Brennan, F. R. Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies. Clin. Pharmacol. Ther.85, 247–258 (2009). ArticleCASPubMed Google Scholar
European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on strategies to identify and mitigate risks for first in human clinical trials with investigational medicinal products. Doc. Ref. EMEA/CHMP/SWP/28367/07. EMA website [online], (2007).
European Medicines Agency. ICH topic M 3 (R2): non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals. Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (CPMP/ICH/286/95). EMA website [online], (2008).
European Medicines Agency. ICH topic S 6: preclinical safety evaluation of biotechnology-derived pharmaceuticals. Note for guidance on preclinical safety evaluation of biotechnology-derived pharmaceuticals (CPMP/ICH/302/95). EMA website [online], (1998).
Lappin, G. & Garner, R. C. The utility of microdosing over the past 5 years. Expert Opin. Drug Metab. Toxicol.4, 1499–1506 (2008). ArticleCASPubMed Google Scholar
European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Position paper on non-clinical safety studies to support clinical trials with a single microdose. CPMP/SWP/2599/02. EMA website [online], (2004).
Liedert, B., Bassus, S., Schneider, C. K., Kalinke, U. & Lower, J. Safety of phase I clinical trials with monoclonal antibodies in Germany — the regulatory requirements viewed in the aftermath of the TGN1412 disaster. Int. J. Clin. Pharmacol. Ther.45, 1–9 (2007). ArticleCASPubMed Google Scholar
Wafelman, A. R. Commentary: symposium report — Development of safe protein therapeutics: pre-clinical, clinical and regulatory issues. Eur. J. Pharm. Sci.34, 223–225 (2008). ArticleCASPubMed Google Scholar
Stebbings, R. et al. “Cytokine storm” in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics. J. Immunol.179, 3325–3331 (2007). ArticleCASPubMed Google Scholar
Findlay, L. et al. Improved in vitro methods to predict the in vivo toxicity in man of therapeutic monoclonal antibodies including TGN1412. J. Immunol. Methods352, 1–12 (2010).References 208 and 209 describein vitrostudies with mAbs and human blood and cell cultures to study the propensity to cause a cytokine storm. ArticleCASPubMed Google Scholar
Willmann, J. K., van, B. N., Dinkelborg, L. M. & Gambhir, S. S. Molecular imaging in drug development. Nature Rev. Drug Discov.7, 591–607 (2008). ArticleCAS Google Scholar
Bullen, A. Microscopic imaging techniques for drug discovery. Nature Rev. Drug Discov.7, 54–67 (2008). ArticleCAS Google Scholar