Have we overestimated the benefit of human(ized) antibodies?

References

• Nelson AL, Dhimolea E, Reichert JM. Development trends for human monoclonal therapeutics. Nat Rev Drug Discov 2010; 9:767 - 767
   PubMed Web of Science ®Google Scholar
• Presta LG. Molecular engineering and design of therapeutic antibodies. Curr Opin Immunol 2008; 20:460 - 470
   PubMed Web of Science ®Google Scholar
• Waldmann H, Hale G. CAMPATH: from concept to clinic. Philos Trans R Soc Lond B Biol Sci 2005; 360:1707 - 1711
   PubMed Web of Science ®Google Scholar
• Harding FA, Stickler MM, Razo J, Dubridge RB. The immunogenicity of humanized and fully human antibodies: Residual immunogenicity resides in the CDR regions. MAbs 2010; 2:256 - 265
   PubMed Web of Science ®Google Scholar
• DeNardo GL, Bradt BM, Mirick GR, DeNardo SJ. Human antiglobulin response to foreign antibodies: therapeutic benefit?. Cancer Immunol Immunother 2003; 52:309 - 316
   PubMed Web of Science ®Google Scholar
• Jones JL, Phuah CL, Cox AL, Thompson SA, Ban M, Shawcross J, et al. IL-21 drives secondary autoimmunity in patients with multiple sclerosis, following therapeutic lymphocyte depletion with alemtuzumab (Campath-1H). J Clin Invest 2009; 119:2052 - 2061
   PubMed Web of Science ®Google Scholar
• Moreau T, Coles A, Wing M, Isaacs J, Hale G, Waldmann H, et al. Transient increase in symptoms associated with cytokine release in patients with multiple sclerosis. Brain 1996; 119:225 - 237
   PubMed Web of Science ®Google Scholar
• Weinblatt ME, Maddison PJ, Bulpitt KJ, Hazleman BL, Urowitz MB, Sturrock RD, et al. CAMPATH-1H, a humanized monoclonal antibody, in refractory rheumatoid arthritis. An intravenous dose-escalation study. Arthritis Rheum 1995; 38:1589 - 1594
   PubMed Web of Science ®Google Scholar
• Chelius D, Ruf P, Gruber P, Ploscher M, Liedtke R, Gansberger E, et al. Structural and functional characterization of the trifunctional antibody catumaxomab. MAbs 2010; 2:309 - 319
   PubMed Web of Science ®Google Scholar
• Seimetz D, Lindhofer H, Bokemeyer C. Development and approval of the trifunctional antibody catumaxomab (anti-EpCAMxanti-CD3) as a targeted cancer immunotherapy. Cancer Treat Rev 2010; 36:458 - 467
   PubMed Web of Science ®Google Scholar
• Oldham RK, Dillman RO. Monoclonal antibodies in cancer therapy: 25 years of progress. J Clin Oncol 2008; 26:1774 - 1777
   PubMed Web of Science ®Google Scholar
• Herold KC. Treatment of type 1 diabetes mellitus to preserve insulin secretion. Endocrinol Metab Clin North Am 2004; 33:93 - 111
   PubMed Web of Science ®Google Scholar
• Herold KC, Gitelman S, Greenbaum C, Puck J, Hagopian W, Gottlieb P, et al. Treatment of patients with new onset Type 1 diabetes with a single course of anti-CD3 mAb Teplizumab preserves insulin production for up to 5 years. Clin Immunol 2009; 132:166 - 173
   PubMed Web of Science ®Google Scholar
• Herold KC, Gitelman SE, Masharani U, Hagopian W, Bisikirska B, Donaldson D, et al. A single course of anti-CD3 monoclonal antibody hOK-T3gamma1 (Ala-Ala) results in improvement in C-peptide responses and clinical parameters for at least 2 years after onset of type 1 diabetes. Diabetes 2005; 54:1763 - 1769
   PubMed Web of Science ®Google Scholar
• Herold KC, Hagopian W, Auger JA, Poumian-Ruiz E, Taylor L, Donaldson D, et al. Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus. N Engl J Med 2002; 346:1692 - 1698
   PubMed Web of Science ®Google Scholar
• Xu D, Alegre ML, Varga SS, Rothermel AL, Collins AM, Pulito VL, et al. In vitro characterization of five humanized OKT3 effector function variant antibodies. Cell Immunol 2000; 200:16 - 26
   PubMed Web of Science ®Google Scholar
• Brennan FR, Morton LD, Spindeldreher S, Kiessling A, Allenspach R, Hey A, et al. Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies. MAbs 2010; 2:233 - 255
   PubMed Web of Science ®Google Scholar
• Clarke JB. Mechanisms of adverse drug reactions to biologics. Handb Exp Pharmacol 2010; 453 - 474
   PubMedGoogle Scholar
• Hwang WY, Foote J. Immunogenicity of engineered antibodies. Methods 2005; 36:3 - 10
   PubMed Web of Science ®Google Scholar
• Muller PY, Brennan FR. Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies. Clin Pharmacol Ther 2009; 85:247 - 258
   PubMed Web of Science ®Google Scholar
• Muller PY, Milton M, Lloyd P, Sims J, Brennan FR. The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies. Curr Opin Biotechnol 2009; 20:722 - 729
   PubMed Web of Science ®Google Scholar
• Coles AJ, Compston DA, Selmaj KW, Lake SL, Moran S, Margolin DH, et al. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med 2008; 359:1786 - 1801
   PubMed Web of Science ®Google Scholar
• Chung DT, Korn T, Richard J, Ruzek M, Kohm AP, Miller S, et al. Anti-thymocyte globulin (ATG) prevents autoimmune encephalomyelitis by expanding myelin antigen-specific Foxp3+ regulatory T cells. Int Immunol 2007; 19:1003 - 1010
   PubMed Web of Science ®Google Scholar
• Puellmann K, Beham AW, Kaminski WE. Cytokine storm and an anti-CD28 monoclonal antibody. N Engl J Med 2006; 355:2592 - 2593
   PubMed Web of Science ®Google Scholar
• Suntharalingam G, Perry MR, Ward S, Brett SJ, Castello-Cortes A, Brunner MD, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 2006; 355:1018 - 1028
   PubMed Web of Science ®Google Scholar
• Takita M, Matsumura T, Kami M. Cytokine storm and an anti-CD28 monoclonal antibody. N Engl J Med 2006; 355:2593
   PubMedGoogle Scholar
• Keymeulen B, Vandemeulebroucke E, Ziegler AG, Mathieu C, Kaufman L, Hale G, et al. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med 2005; 352:2598 - 2608
   PubMed Web of Science ®Google Scholar
• Somerfield J, Hill-Cawthorne GA, Lin A, Zandi MS, McCarthy C, Jones JL, et al. A novel strategy to reduce the immunogenicity of biological therapies. J Immunol 2010; 185:763 - 768
   PubMed Web of Science ®Google Scholar
• Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov 2002; 1:457 - 462
   PubMed Web of Science ®Google Scholar
• Shankar G, Shores E, Wagner C, Mire-Sluis A. Scientific and regulatory considerations on the immunogenicity of biologics. Trends Biotechnol 2006; 24:274 - 280
   PubMed Web of Science ®Google Scholar
• Azinovic I, DeNardo GL, Lamborn KR, Mirick G, Goldstein D, Bradt BM, et al. Survival benefit associated with human anti-mouse antibody (HAMA) in patients with B-cell malignancies. Cancer Immunol Immunother 2006; 55:1451 - 1458
   PubMed Web of Science ®Google Scholar
• Miotti S, Negri DR, Valota O, Calabrese M, Bolhuis RL, Gratama JW, et al. Level of anti-mouse-antibody response induced by bi-specific monoclonal antibody OC/TR in ovarian-carcinoma patients is associated with longer survival. Int J Cancer 1999; 84:62 - 68
   PubMed Web of Science ®Google Scholar
• Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med 2006; 355:1967 - 1977
   PubMed Web of Science ®Google Scholar
• Safdar N, Smith J, Knasinski V, Sherkow C, Herrforth C, Knechtle S, et al. Infections after the use of alemtuzumab in solid organ transplant recipients: a comparative study. Diagn Microbiol Infect Dis 2010; 66:7 - 15
   PubMed Web of Science ®Google Scholar
• Book BK, Pescovitz MD, Agarwal A, Hardwick LL, Henson SL, Milgrom ML, et al. In vitro monitoring of in vivo development of human anti-thymoglobulin antibodies by ELISA. Transplant Proc 2006; 38:2869 - 2871
   PubMed Web of Science ®Google Scholar
• Broeders N, Wissing KM, Crusiaux A, Kinnaert P, Vereerstraeten P, Abramowicz D. Mycophenolate mofetil, together with cyclosporin A, prevents anti-OKT3 antibody response in kidney transplant recipients. J Am Soc Nephrol 1998; 9:1521 - 1525
   PubMed Web of Science ®Google Scholar
• Coles AJ, Cox A, Le Page E, Jones J, Trip SA, Deans J, et al. The window of therapeutic opportunity in multiple sclerosis: evidence from monoclonal antibody therapy. J Neurol 2006; 253:98 - 108
   PubMed Web of Science ®Google Scholar
• Jones JL, Coles AJ. Campath-1H treatment of multiple sclerosis. Neurodegener Dis 2008; 5:27 - 31
   PubMed Web of Science ®Google Scholar
• Chatenoud L. Restoration of self-tolerance is a feasible approach to control ongoing beta-cell specific autoreactivity: its relevance for treatment in established diabetes and islet transplantation. Diabetologia 2001; 44:521 - 536
   PubMed Web of Science ®Google Scholar
• Chatenoud L. The use of CD3-specific antibodies in autoimmune diabetes: a step toward the induction of immune tolerance in the clinic. Handb Exp Pharmacol 2008; 221 - 236
   PubMedGoogle Scholar
• Vanderlugt CJ, Miller SD. Epitope spreading. Curr Opin Immunol 1996; 8:831 - 836
   PubMed Web of Science ®Google Scholar
• Vanderlugt CL, Begolka WS, Neville KL, Katz-Levy Y, Howard LM, Eagar TN, et al. The functional significance of epitope spreading and its regulation by co-stimulatory molecules. Immunol Rev 1998; 164:63 - 72
   PubMed Web of Science ®Google Scholar
• Luo X, Herold KC, Miller SD. Immunotherapy of type 1 diabetes: where are we and where should we be going?. Immunity 2010; 32:488 - 499
   PubMed Web of Science ®Google Scholar
• Vanderlugt CL, Miller SD. Epitope spreading in immune-mediated diseases: implications for immunotherapy. Nat Rev Immunol 2002; 2:85 - 95
   PubMed Web of Science ®Google Scholar
• Sempe P, Bedossa P, Richard MF, Villa MC, Bach JF, Boitard C. Anti-alpha/beta T cell receptor monoclonal antibody provides an efficient therapy for autoimmune diabetes in nonobese diabetic (NOD) mice. Eur J Immunol 1991; 21:1163 - 1169
   PubMed Web of Science ®Google Scholar
• Kohm AP, Williams JS, Bickford AL, McMahon JS, Chatenoud L, Bach JF, et al. Treatment with non-mitogenic anti-CD3 monoclonal antibody induces CD4+ T cell unresponsiveness and functional reversal of established experimental autoimmune encephalomyelitis. J Immunol 2005; 174:4525 - 4534
   PubMed Web of Science ®Google Scholar
• Scheinfeld N. Alefacept: a safety profile. Expert Opin Drug Saf 2005; 4:975 - 985
   PubMedGoogle Scholar
• Bender NK, Heilig CE, Droll B, Wohlgemuth J, Armbruster FP, Heilig B. Immunogenicity, efficacy and adverse events of adalimumab in RA patients. Rheumatol Int 2007; 27:269 - 274
   PubMed Web of Science ®Google Scholar
• Coenen MJ, Toonen EJ, Scheffer H, Radstake TR, Barrera P, Franke B. Pharmacogenetics of anti-TNF treatment in patients with rheumatoid arthritis. Pharmacogenomics 2007; 8:761 - 773
   PubMed Web of Science ®Google Scholar
• Shealy D, Cai A, Staquet K, Baker A, Lacy ER, Johns L, et al. Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor alpha. MAbs 2010; 2:428 - 439
   PubMed Web of Science ®Google Scholar
• Kay J, Rahman MU. Golimumab: A novel human anti-TNFalpha monoclonal antibody for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. Core Evid 2010; 4:159 - 170
   PubMedGoogle Scholar
• Kay J, Matteson EL, Dasgupta B, Nash P, Durez P, Hall S, et al. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum 2008; 58:964 - 975
   PubMed Web of Science ®Google Scholar
• Baker DE. Certolizumab pegol for the treatment of Crohn's disease. Expert Rev Clin Immunol 2009; 5:683 - 691
   PubMed Web of Science ®Google Scholar
• Lichtenstein GR, Thomsen OO, Schreiber S, Lawrance IC, Hanauer SB, Bloomfield R, et al. Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months. Clin Gastroenterol Hepatol 2010; 8:600 - 609
   PubMed Web of Science ®Google Scholar
• Gandhi M, Alwawi E, Gordon KB. Anti-p40 antibodies ustekinumab and briakinumab: blockade of interleukin-12 and interleukin-23 in the treatment of psoriasis. Semin Cutan Med Surg 2010; 29:48 - 52
   PubMed Web of Science ®Google Scholar
• Cingoz O. Ustekinumab. MAbs 2009; 1:216 - 221
   PubMed Web of Science ®Google Scholar
• Dhimolea E. Canakinumab. MAbs 2010; 2:3 - 13
   PubMed Web of Science ®Google Scholar
• Lachmann HJ, Kone-Paut I, Kuemmerle-Deschner JB, Leslie KS, Hachulla E, Quartier P, et al. Use of canakinumab in the cryopyrin-associated periodic syndrome. N Engl J Med 2009; 360:2416 - 2425
   PubMed Web of Science ®Google Scholar
• Sharma R, Sharma CL, Mahajan A. Biological agents targeting beyond TNFalpha. Indian J Crit Care Med 2008; 12:181 - 189
   PubMedGoogle Scholar
• Khaw P, Grehn F, Hollo G, Overton B, Wilson R, Vogel R, et al. A phase III study of subconjunctival human anti-transforming growth factor beta(2) monoclonal antibody (CAT-152) to prevent scarring after first-time trabeculectomy. Ophthalmology 2007; 114:1822 - 1830
   PubMed Web of Science ®Google Scholar
• Rossi JF, Fegueux N, Lu ZY, Legouffe E, Exbrayat C, Bozonnat MC, et al. Optimizing the use of anti-interleukin-6 monoclonal antibody with dexamethasone and 140 mg/m2 of melphalan in multiple myeloma: results of a pilot study including biological aspects. Bone Marrow Transplant 2005; 36:771 - 779
   PubMed Web of Science ®Google Scholar
• Emilie D, Wijdenes J, Gisselbrecht C, Jarrousse B, Billaud E, Blay JY, et al. Administration of an anti-interleukin-6 monoclonal antibody to patients with acquired immunodeficiency syndrome and lymphoma: effect on lymphoma growth and on B clinical symptoms. Blood 1994; 84:2472 - 2479
   PubMed Web of Science ®Google Scholar
• Fisher CJ Jr, Opal SM, Dhainaut JF, Stephens S, Zimmerman JL, Nightingale P, et al. Influence of an anti-tumor necrosis factor monoclonal antibody on cytokine levels in patients with sepsis. The CB0006 Sepsis Syndrome Study Group. Crit Care Med 1993; 21:318 - 327
   PubMed Web of Science ®Google Scholar
• Llorente L, Richaud-Patin Y, Garcia-Padilla C, Claret E, Jakez-Ocampo J, Cardiel MH, et al. Clinical and biologic effects of anti-interleukin-10 monoclonal antibody administration in systemic lupus erythematosus. Arthritis Rheum 2000; 43:1790 - 1800
   PubMed Web of Science ®Google Scholar
• Panacek EA, Marshall JC, Albertson TE, Johnson DH, Johnson S, MacArthur RD, et al. Efficacy and safety of the monoclonal anti-tumor necrosis factor antibody F(ab')2 fragment afelimomab in patients with severe sepsis and elevated interleukin-6 levels. Crit Care Med 2004; 32:2173 - 2182
   PubMed Web of Science ®Google Scholar
• Reinhart K, Menges T, Gardlund B, Harm Zwaveling J, Smithes M, Vincent JL, et al. Randomized, placebo-controlled trial of the anti-tumor necrosis factor antibody fragment afelimomab in hyperinflammatory response during severe sepsis: The RAMSES Study. Crit Care Med 2001; 29:765 - 769
   PubMed Web of Science ®Google Scholar
• Cohen J, Carlet J. INTERSEPT: an international, multicenter, placebo-controlled trial of monoclonal antibody to human tumor necrosis factor-alpha in patients with sepsis. International Sepsis Trial Study Group. Crit Care Med 1996; 24:1431 - 1440
   PubMed Web of Science ®Google Scholar
• Mestel DS, Beyer M, Mobs M, Steinhoff M, Sterry W, Assaf C. Zanolimumab, a human monoclonal antibody targeting CD4 in the treatment of mycosis fungoides and Sezary syndrome. Expert Opin Biol Ther 2008; 8:1929 - 1939
   PubMed Web of Science ®Google Scholar
• Ansell SM, Hurvitz SA, Koenig PA, LaPlant BR, Kabat BF, Fernando D, et al. Phase I study of ipilimumab, an anti-CTLA-4 monoclonal antibody, in patients with relapsed and refractory B-cell non-Hodgkin lymphoma. Clin Cancer Res 2009; 15:6446 - 6453
   PubMed Web of Science ®Google Scholar
• Weber J, Thompson JA, Hamid O, Minor D, Amin A, Ron I, et al. A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res 2009; 15:5591 - 5598
   PubMed Web of Science ®Google Scholar
• Weber J. Ipilimumab: controversies in its development, utility and autoimmune adverse events. Cancer Immunol Immunother 2009; 58:823 - 830
   PubMed Web of Science ®Google Scholar
• Sanderson K, Scotland R, Lee P, Liu D, Groshen S, Snively J, et al. Autoimmunity in a phase I trial of a fully human anti-cytotoxic T-lymphocyte antigen-4 monoclonal antibody with multiple melanoma peptides and Montanide ISA 51 for patients with resected stages III and IV melanoma. J Clin Oncol 2005; 23:741 - 750
   PubMed Web of Science ®Google Scholar
• Kirkwood JM, Lorigan P, Hersey P, Hauschild A, Robert C, McDermott D, et al. Phase II trial of tremelimumab (CP-675,206) in patients with advanced refractory or relapsed melanoma. Clin Cancer Res 2010; 16:1042 - 1048
   PubMed Web of Science ®Google Scholar
• Camacho LH. Novel therapies targeting the immune system: CTLA4 blockade with tremelimumab (CP-675,206), a fully human monoclonal antibody. Expert Opin Investig Drugs 2008; 17:371 - 385
   PubMed Web of Science ®Google Scholar
• Baumgart DC. Veto on vedolizumab (MLN0002) for Crohn's disease. Inflamm Bowel Dis 2010; 16:537 - 538
   PubMed Web of Science ®Google Scholar
• Soler D, Chapman T, Yang LL, Wyant T, Egan R, Fedyk ER. The binding specificity and selective antagonism of vedolizumab, an anti-alpha4beta7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther 2009; 330:864 - 875
   PubMed Web of Science ®Google Scholar
• Baumgart DC, Targan SR, Dignass AU, Mayer L, van Assche G, Hommes DW, et al. Prospective randomized open-label multicenter phase I/II dose escalation trial of visilizumab (HuM291) in severe steroid-refractory ulcerative colitis. Inflamm Bowel Dis 2010; 16:620 - 629
   PubMed Web of Science ®Google Scholar
• Martin PJ, Nelson BJ, Appelbaum FR, Anasetti C, Deeg HJ, Hansen JA, et al. Evaluation of a CD5-specific immunotoxin for treatment of acute graft-versus-host disease after allogeneic marrow transplantation. Blood 1996; 88:824 - 830
   PubMed Web of Science ®Google Scholar
• Sgro C. Side-effects of a monoclonal antibody, muromonab CD3/orthoclone OKT3: bibliographic review. Toxicology 1995; 105:23 - 29
   PubMed Web of Science ®Google Scholar
• Waid TH, Lucas BA, Thompson JS, McKeown JW, Brown S, Kryscio R, et al. Treatment of renal allograft rejection with T10B9.1A31 or OKT3: final analysis of a phase II clinical trial. Transplantation 1997; 64:274 - 281
   PubMed Web of Science ®Google Scholar
• Knight RJ, Kurrle R, McClain J, Racenberg J, Baghdahsarian V, Kerman R, et al. Clinical evaluation of induction immunosuppression with a murine IgG2b monoclonal antibody (BMA 031) directed toward the human alpha/beta-T cell receptor. Transplantation 1994; 57:1581 - 1588
   PubMed Web of Science ®Google Scholar
• Dillman RO, Shawler DL, Sobol RE, Collins HA, Beauregard JC, Wormsley SB, et al. Murine monoclonal antibody therapy in two patients with chronic lymphocytic leukemia. Blood 1982; 59:1036 - 1045
   PubMed Web of Science ®Google Scholar
• Schroff RW, Farrell MM, Klein RA, Oldham RK, Foon KA. T65 antigen modulation in a phase I monoclonal antibody trial with chronic lymphocytic leukemia patients. J Immunol 1984; 133:1641 - 1648
   PubMed Web of Science ®Google Scholar
• Soulillou JP, Cantarovich D, Le Mauff B, Giral M, Robillard N, Hourmant M, et al. Randomized controlled trial of a monoclonal antibody against the interleukin-2 receptor (33B3.1) as compared with rabbit antithymocyte globulin for prophylaxis against rejection of renal allografts. N Engl J Med 1990; 322:1175 - 1182
   PubMed Web of Science ®Google Scholar
• Rumbach L, Racadot E, Bataillard M, Galmiche J, Henlin JL, Trutmann M, et al. [Open therapeutic trial of anti-T CD4 monoclonal antibody in multiple sclerosis]. Rev Neurol (Paris) 1994; 150:418 - 424
   PubMed Web of Science ®Google Scholar
• Racadot E, Rumbach L, Bataillard M, Galmiche J, Henlin JL, Truttmann M, et al. Treatment of multiple sclerosis with anti-CD4 monoclonal antibody. A preliminary report on B-F5 in 21 patients. J Autoimmun 1993; 6:771 - 786
   PubMed Web of Science ®Google Scholar
• Przepiorka D, Phillips GL, Ratanatharathorn V, Cottler-Fox M, Sehn LH, Antin JH, et al. A phase II study of BTI-322, a monoclonal anti-CD2 antibody, for treatment of steroid-resistant acute graft-versus-host disease. Blood 1998; 92:4066 - 4071
   PubMed Web of Science ®Google Scholar
• Lemery SJ, Zhang J, Rothmann MD, Yang J, Earp J, Zhao H, et al. US Food and Drug Administration approval: Ofatumumab for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab. Clin Cancer Res 2010; 16:4331 - 4338
   PubMed Web of Science ®Google Scholar
• Wierda WG, Kipps TJ, Mayer J, Stilgenbauer S, Williams CD, Hellmann A, et al. Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol 2010; 28:1749 - 1755
   PubMed Web of Science ®Google Scholar
• Ding C. Belimumab, an anti-BLyS human monoclonal antibody for potential treatment of inflammatory autoimmune diseases. Expert Opin Biol Ther 2008; 8:1805 - 1814
   PubMed Web of Science ®Google Scholar
• Furie R, Stohl W, Ginzler EM, Becker M, Mishra N, Chatham W, et al. Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus. Arthritis Res Ther 2008; 10:109
   PubMed Web of Science ®Google Scholar
• Rodrigo GJ, Neffen H, Castro-Rodriguez JA. Efficacy and safety of subcutaneous omalizumab versus placebo as add on therapy to corticosteroids for children and adults with asthma: A systematic review. Chest 2010; http://dx.doi.org/10.1378/chest.10-1194
   PubMed Web of Science ®Google Scholar
• Easthope S, Jarvis B. Omalizumab. Drugs 2001; 61:253 - 260
   PubMed Web of Science ®Google Scholar
• Genovese MC, Kaine JL, Lowenstein MB, Del Giudice J, Baldassare A, Schechtman J, et al. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: a phase I/II randomized, blinded, placebo-controlled, dose-ranging study. Arthritis Rheum 2008; 58:2652 - 2661
   PubMed Web of Science ®Google Scholar
• Leonard JP, Coleman M, Ketas J, Ashe M, Fiore JM, Furman RR, et al. Combination antibody therapy with epratuzumab and rituximab in relapsed or refractory non-Hodgkin's lymphoma. J Clin Oncol 2005; 23:5044 - 5051
   PubMed Web of Science ®Google Scholar
• Leonard JP, Coleman M, Ketas JC, Chadburn A, Furman R, Schuster MW, et al. Epratuzumab, a humanized anti-CD22 antibody, in aggressive non-Hodgkin's lymphoma: phase I/II clinical trial results. Clin Cancer Res 2004; 10:5327 - 5334
   PubMed Web of Science ®Google Scholar
• Morschhauser F, Kraeber-Bodere F, Wegener WA, Harousseau JL, Petillon MO, Huglo D, et al. High rates of durable responses with anti-CD22 fractionated radioimmunotherapy: results of a multicenter, phase I/II study in non-Hodgkin's lymphoma. J Clin Oncol 2010; 28:3709 - 3716
   PubMed Web of Science ®Google Scholar
• Vitetta ES, Stone M, Amlot P, Fay J, May R, Till M, et al. Phase I immunotoxin trial in patients with B-cell lymphoma. Cancer Res 1991; 51:4052 - 4058
   PubMed Web of Science ®Google Scholar
• Wang M, Oki Y, Pro B, Romaguera JE, Rodriguez MA, Samaniego F, et al. Phase II study of yttrium-90-ibritumomab tiuxetan in patients with relapsed or refractory mantle cell lymphoma. J Clin Oncol 2009; 27:5213 - 5218
   PubMed Web of Science ®Google Scholar
• Kaminski MS, Zelenetz AD, Press OW, Saleh M, Leonard J, Fehrenbacher L, et al. Pivotal study of iodine I 131 tositumomab for chemotherapy-refractory low-grade or transformed low-grade B-cell non-Hodgkin's lymphomas. J Clin Oncol 2001; 19:3918 - 3928
   PubMed Web of Science ®Google Scholar
• Dubois EA, Cohen AF. Eculizumab. Br J Clin Pharmacol 2009; 68:318 - 319
   PubMed Web of Science ®Google Scholar
• Selewski DT, Shah GV, Segal BM, Rajdev PA, Mukherji SK. Natalizumab (Tysabri). AJNR Am J Neuroradiol 2010; 31:1588 - 1589
   PubMed Web of Science ®Google Scholar
• Johnson KP. Natalizumab (Tysabri) treatment for relapsing multiple sclerosis. Neurologist 2007; 13:182 - 187
   PubMed Web of Science ®Google Scholar
• Stuve O, Bennett JL. Pharmacological properties, toxicology and scientific rationale for the use of natalizumab (Tysabri) in inflammatory diseases. CNS Drug Rev 2007; 13:79 - 95
   PubMedGoogle Scholar
• Vincenti F, Mendez R, Pescovitz M, Rajagopalan PR, Wilkinson AH, Butt K, et al. A phase I/II randomized open-label multicenter trial of efalizumab, a humanized anti-CD11a, anti-LFA-1 in renal transplantation. Am J Transplant 2007; 7:1770 - 1777
   PubMed Web of Science ®Google Scholar
• Rusnak JM, Kopecky SL, Clements IP, Gibbons RJ, Holland AE, Peterman HS, et al. An anti-CD11/CD18 monoclonal antibody in patients with acute myocardial infarction having percutaneous transluminal coronary angioplasty (the FESTIVAL study). Am J Cardiol 2001; 88:482 - 487
   PubMed Web of Science ®Google Scholar
• Ellis GK, Bone HG, Chlebowski R, Paul D, Spadafora S, Smith J, et al. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. J Clin Oncol 2008; 26:4875 - 4882
   PubMed Web of Science ®Google Scholar
• Brener SJ, Ellis SG, Schneider J, Apperson-Hansen C, Topol EJ. Abciximab-facilitated percutaneous coronary intervention and long-term survival—a prospective single-center registry. Eur Heart J 2003; 24:630 - 638
   PubMed Web of Science ®Google Scholar
• Brenner MK, Wulf GG, Rill DR, Luo KL, Goodell MA, Mei Z, et al. Complement-fixing CD45 monoclonal antibodies to facilitate stem cell transplantation in mouse and man. Ann NY Acad Sci 2003; 996:80 - 88
   PubMed Web of Science ®Google Scholar
• Krance RA, Kuehnle I, Rill DR, Mei Z, Pinetta C, Evans W, et al. Hematopoietic and immunomodulatory effects of lytic CD45 monoclonal antibodies in patients with hematologic malignancy. Biol Blood Marrow Transplant 2003; 9:273 - 281
   PubMed Web of Science ®Google Scholar
• Ball ED, Selvaggi K, Hurd D, Herzig R, Clark L, Malley V, et al. Phase I clinical trial of serotherapy in patients with acute myeloid leukemia with an immunoglobulin M monoclonal antibody to CD15. Clin Cancer Res 1995; 1:965 - 972
   PubMed Web of Science ®Google Scholar
• Hartmann F, Renner C, Jung W, Deisting C, Juwana M, Eichentopf B, et al. Treatment of refractory Hodgkin's disease with an anti-CD16/CD30 bispecific antibody. Blood 1997; 89:2042 - 2047
   PubMed Web of Science ®Google Scholar
• Schneider D, Berrouschot J, Brandt T, Hacke W, Ferbert A, Norris SH, et al. Safety, pharmacokinetics and biological activity of enlimomab (anti-ICAM-1 antibody): an open-label, dose escalation study in patients hospitalized for acute stroke. Eur Neurol 1998; 40:78 - 83
   PubMed Web of Science ®Google Scholar
• Vainio PJ, Kortekangas-Savolainen O, Mikkola JH, Jaakkola K, Kalimo K, Jalkanen S, et al. Safety of blocking vascular adhesion protein-1 in patients with contact dermatitis. Basic Clin Pharmacol Toxicol 2005; 96:429 - 435
   PubMed Web of Science ®Google Scholar
• Hourmant M, Bedrossian J, Durand D, Lebranchu Y, Renoult E, Caudrelier P, et al. A randomized multicenter trial comparing leukocyte function-associated antigen-1 monoclonal antibody with rabbit antithymocyte globulin as induction treatment in first kidney transplantations. Transplantation 1996; 62:1565 - 1570
   PubMed Web of Science ®Google Scholar
• Iking-Konert C, Stocks S, Weinsberg F, Engelbrecht R, Bleck E, Perniok A, et al. First clinical trials of a new heteropolymer technology agent in normal healthy volunteers and patients with systemic lupus erythematosus: safety and proof of principle of the antigen-heteropolymer ETI-104. Ann Rheum Dis 2004; 63:1104 - 1112
   PubMed Web of Science ®Google Scholar
• Van Cutsem E, Siena S, Humblet Y, Canon JL, Maurel J, Bajetta E, et al. An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy. Ann Oncol 2008; 19:92 - 98
   PubMed Web of Science ®Google Scholar
• Van Cutsem E, Peeters M, Siena S, Humblet Y, Hendlisz A, Neyns B, et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 2007; 25:1658 - 1664
   PubMed Web of Science ®Google Scholar
• Cohenuram M, Saif MW. Panitumumab the first fully human monoclonal antibody: from the bench to the clinic. Anticancer Drugs 2007; 18:7 - 15
   PubMed Web of Science ®Google Scholar
• Rivera F, Salcedo M, Vega N, Blanco Y, Lopez C. Current situation of zalutumumab. Expert Opin Biol Ther 2009; 9:667 - 674
   PubMed Web of Science ®Google Scholar
• Spratlin JL, Cohen RB, Eadens M, Gore L, Camidge DR, Diab S, et al. Phase I pharmacologic and biologic study of ramucirumab (IMC-1121B), a fully human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor-2. J Clin Oncol 2010; 28:780 - 787
   PubMed Web of Science ®Google Scholar
• Lubner SJ, Mahoney MR, Kolesar JL, Loconte NK, Kim GP, Pitot HC, et al. Report of a multicenter phase II trial testing a combination of biweekly bevacizumab and daily erlotinib in patients with unresectable biliary cancer: A phase II consortium study. J Clin Oncol 2010; 28:3491 - 3497
   PubMed Web of Science ®Google Scholar
• Kuenen B, Witteveen PO, Ruijter R, Giaccone G, Dontabhaktuni A, Fox F, et al. A phase I pharmacologic study of necitumumab (IMC-11F8), a fully human IgG1 monoclonal antibody directed against EGFR in patients with advanced solid malignancies. Clin Cancer Res 2010; 16:1915 - 1923
   PubMed Web of Science ®Google Scholar
• Trastuzumab product label 1998; www.accessdata.fda.gov/drugsatfda_docs/label/1998/trasgen092598lb.pdf
   Google Scholar
• Agus DB, Gordon MS, Taylor C, Natale RB, Karlan B, Mendelson DS, et al. Phase I clinical study of pertuzumab, a novel HER dimerization inhibitor, in patients with advanced cancer. J Clin Oncol 2005; 23:2534 - 2543
   PubMed Web of Science ®Google Scholar
• Ebel W, Routhier EL, Foley B, Jacob S, McDonough JM, Patel RK, et al. Preclinical evaluation of MORAb-003, a humanized monoclonal antibody antagonizing folate receptor-alpha. Cancer Immun 2007; 7:6
   PubMedGoogle Scholar
• Spannuth WA, Sood AK, Coleman RL. Farletuzumab in epithelial ovarian carcinoma. Expert Opin Biol Ther 2010; 10:431 - 437
   PubMed Web of Science ®Google Scholar
• Olmos D, Postel-Vinay S, Molife LR, Okuno SH, Schuetze SM, Paccagnella ML, et al. Safety, pharmacokinetics and preliminary activity of the anti-IGF-1R antibody figitumumab (CP-751,871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study. Lancet Oncol 2010; 11:129 - 135
   PubMed Web of Science ®Google Scholar
• Karp DD, Pollak MN, Cohen RB, Eisenberg PD, Haluska P, Yin D, et al. Safety, pharmacokinetics and pharmacodynamics of the insulin-like growth factor type 1 receptor inhibitor figitumumab (CP-751,871) in combination with paclitaxel and carboplatin. J Thorac Oncol 2009; 4:1397 - 1403
   PubMed Web of Science ®Google Scholar
• O'Donnell RT, DeNardo SJ, Shi XB, Mirick GR, DeNardo GL, Kroger LA, et al. L6 monoclonal antibody binds prostate cancer. Prostate 1998; 37:91 - 97
   PubMed Web of Science ®Google Scholar
• Buchegger F, Mach JP, Pelegrin A, Gillet M, Vogel CA, Buclin T, et al. Radiolabeled chimeric anti-CEA monoclonal antibody compared with the original mouse monoclonal antibody for surgically treated colorectal carcinoma. J Nucl Med 1995; 36:420 - 429
   PubMed Web of Science ®Google Scholar
• Behr TM, Sharkey RM, Juweid ME, Dunn RM, Vagg RC, Ying Z, et al. Phase I/II clinical radioimmunotherapy with an iodine-131-labeled anti-carcinoembryonic antigen murine monoclonal antibody IgG. J Nucl Med 1997; 38:858 - 870
   PubMed Web of Science ®Google Scholar
• Juweid M, Sharkey RM, Swayne LC, Griffiths GL, Dunn R, Goldenberg DM. Pharmacokinetics, dosimetry and toxicity of rhenium-188-labeled anti-carcinoembryonic antigen monoclonal antibody, MN-14, in gastrointestinal cancer. J Nucl Med 1998; 39:34 - 42
   PubMed Web of Science ®Google Scholar
• Faillot T, Magdelenat H, Mady E, Stasiecki P, Fohanno D, Gropp P, et al. A phase I study of an anti-epidermal growth factor receptor monoclonal antibody for the treatment of malignant gliomas. Neurosurgery 1996; 39:478 - 483
   PubMed Web of Science ®Google Scholar
• Deb N, Goris M, Trisler K, Fowler S, Saal J, Ning S, et al. Treatment of hormone-refractory prostate cancer with 90Y-CYT-356 monoclonal antibody. Clin Cancer Res 1996; 2:1289 - 1297
   PubMed Web of Science ®Google Scholar
• Gonzalez R, Salem P, Bunn PA Jr, Zukiwski AA, Lamb R, Benjamin RS, et al. Single-dose murine monoclonal antibody ricin A chain immunotoxin in the treatment of metastatic melanoma: a phase I trial. Mol Biother 1991; 3:192 - 196
   PubMedGoogle Scholar
• Spitler LE, del Rio M, Khentigan A, Wedel NI, Brophy NA, Miller LL, et al. Therapy of patients with malignant melanoma using a monoclonal antimelanoma antibody-ricin A chain immunotoxin. Cancer Res 1987; 47:1717 - 1723
   PubMed Web of Science ®Google Scholar
• Elias DJ, Kline LE, Robbins BA, Johnson HC Jr, Pekny K, Benz M, et al. Monoclonal antibody KS1/4-methotrexate immunoconjugate studies in non-small cell lung carcinoma. Am J Respir Crit Care Med 1994; 150:1114 - 1122
   PubMed Web of Science ®Google Scholar
• Elias DJ, Hirschowitz L, Kline LE, Kroener JF, Dillman RO, Walker LE, et al. Phase I clinical comparative study of monoclonal antibody KS1/4 and KS1/4-methotrexate immunconjugate in patients with non-small cell lung carcinoma. Cancer Res 1990; 50:4154 - 4159
   PubMed Web of Science ®Google Scholar
• Knox SJ, Goris ML, Tempero M, Weiden PL, Gentner L, Breitz H, et al. Phase II trial of yttrium-90-DOTA-biotin pretargeted by NR-LU-10 antibody/streptavidin in patients with metastatic colon cancer. Clin Cancer Res 2000; 6:406 - 414
   PubMed Web of Science ®Google Scholar
• Stroomer JW, Roos JC, Sproll M, Quak JJ, Heider KH, Wilhelm BJ, et al. Safety and biodistribution of 99mTechnetium-labeled anti-CD44v6 monoclonal antibody BIWA 1 in head and neck cancer patients. Clin Cancer Res 2000; 6:3046 - 3055
   PubMed Web of Science ®Google Scholar
• Valone FH, Kaufman PA, Guyre PM, Lewis LD, Memoli V, Deo Y, et al. Phase Ia/Ib trial of bispecific antibody MDX-210 in patients with advanced breast or ovarian cancer that overexpresses the proto-oncogene HER-2/neu. J Clin Oncol 1995; 13:2281 - 2292
   PubMed Web of Science ®Google Scholar
• Jager M, Schoberth A, Ruf P, Hess J, Lindhofer H. The trifunctional antibody ertumaxomab destroys tumor cells that express low levels of human epidermal growth factor receptor 2. Cancer Res 2009; 69:4270 - 4276
   PubMed Web of Science ®Google Scholar
• Kiewe P, Hasmuller S, Kahlert S, Heinrigs M, Rack B, Marme A, et al. Phase I trial of the trifunctional anti-HER2 x anti-CD3 antibody ertumaxomab in metastatic breast cancer. Clin Cancer Res 2006; 12:3085 - 3091
   PubMed Web of Science ®Google Scholar
• Sebastian M, Kiewe P, Schuette W, Brust D, Peschel C, Schneller F, et al. Treatment of malignant pleural effusion with the trifunctional antibody catumaxomab (Removab) (anti-EpCAM x Anti-CD3): results of a phase 1/2 study. J Immunother 2009; 32:195 - 202
   PubMed Web of Science ®Google Scholar
• Borghaei H, Alpaugh K, Hedlund G, Forsberg G, Langer C, Rogatko A, et al. Phase I dose escalation, pharmacokinetic and pharmacodynamic study of naptumomab estafenatox alone in patients with advanced cancer and with docetaxel in patients with advanced non-small-cell lung cancer. J Clin Oncol 2009; 27:4116 - 4123
   PubMed Web of Science ®Google Scholar
• Chen ZN, Mi L, Xu J, Song F, Zhang Q, Zhang Z, et al. Targeting radioimmunotherapy of hepatocellular carcinoma with iodine (131I) metuximab injection: clinical phase I/II trials. Int J Radiat Oncol Biol Phys 2006; 65:435 - 444
   PubMed Web of Science ®Google Scholar
• Deeg HJ, Blazar BR, Bolwell BJ, Long GD, Schuening F, Cunningham J, et al. Treatment of steroid-refractory acute graft-versus-host disease with anti-CD147 monoclonal antibody ABX-CBL. Blood 2001; 98:2052 - 2058
   PubMed Web of Science ®Google Scholar
• Oei AL, Moreno M, Verheijen RH, Sweep FC, Thomas CM, Massuger LF, et al. Induction of IgG antibodies to MUC1 and survival in patients with epithelial ovarian cancer. Int J Cancer 2008; 123:1848 - 1853
   PubMedGoogle Scholar
• Verheijen RH, Massuger LF, Benigno BB, Epenetos AA, Lopes A, Soper JT, et al. Phase III trial of intraperitoneal therapy with yttrium-90-labeled HMFG1 murine monoclonal antibody in patients with epithelial ovarian cancer after a surgically defined complete remission. J Clin Oncol 2006; 24:571 - 578
   PubMed Web of Science ®Google Scholar
• Shaw DM, Connolly NB, Patel PM, Kilany S, Hedlund G, Nordle O, et al. A phase II study of a 5T4 oncofoetal antigen tumour-targeted superantigen (ABR-214936) therapy in patients with advanced renal cell carcinoma. Br J Cancer 2007; 96:567 - 574
   PubMed Web of Science ®Google Scholar
• Kuzel T, Rosen ST, Zimmer AM, Silverstein EA, Spies S, Saletan SL, et al. A phase I escalating-dose safety, dosimetry and efficacy study of radiolabeled monoclonal antibody LYM-1. Cancer Biother 1993; 8:3 - 16
   PubMedGoogle Scholar
• Derkx B, Wittes J, McCloskey R. Randomized, placebo-controlled trial of HA-1A, a human monoclonal antibody to endotoxin, in children with meningococcal septic shock. European Pediatric Meningococcal Septic Shock Trial Study Group. Clin Infect Dis 1999; 28:770 - 777
   PubMed Web of Science ®Google Scholar
• Daifuku R, Haenftling K, Young J, Groves ES, Turrell C, Meyers FJ. Phase I study of antilipopolysaccharide human monoclonal antibody MAB-T88. Antimicrob Agents Chemother 1992; 36:2349 - 2351
   PubMed Web of Science ®Google Scholar
• Albertson TE, Panacek EA, MacArthur RD, Johnson SB, Benjamin E, Matuschak GM, et al. Multicenter evaluation of a human monoclonal antibody to Enterobacteriaceae common antigen in patients with Gram-negative sepsis. Crit Care Med 2003; 31:419 - 427
   PubMed Web of Science ®Google Scholar
• Migone TS, Subramanian GM, Zhong J, Healey LM, Corey A, Devalaraja M, et al. Raxibacumab for the treatment of inhalational anthrax. N Engl J Med 2009; 361:135 - 144
   PubMed Web of Science ®Google Scholar
• Harkonen S, Scannon P, Mischak RP, Spitler LE, Foxall C, Kennedy D, et al. Phase I study of a murine monoclonal anti-lipid A antibody in bacteremic and nonbacteremic patients. Antimicrob Agents Chemother 1988; 32:710 - 716
   PubMed Web of Science ®Google Scholar