Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor α

References

• Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther 2008; 117:244 - 279
   PubMed Web of Science ®Google Scholar
• Wong M, Ziring D, Korin Y, Desai S, Kim S, Lin J, et al. TNFα blockade in human diseases: mechanisms and future directions. Clin Immunol 2008; 126:121 - 136
   PubMed Web of Science ®Google Scholar
• Feldmann M, Brennan FM, Williams RO, Woody JN, Maini RN. The transfer of a laboratory based hypothesis to a clinically useful therapy: the development of anti-TNF therapy of rheumatoid arthritis. Best Pract Res Clin Rheumatol 2004; 18:59 - 80
   PubMed Web of Science ®Google Scholar
• Ackermann C, Kavanaugh A. Tumor necrosis factor as a therapeutic target of rheumatologic disease. Expert Opin Ther Targets 2007; 11:1369 - 1384
   PubMed Web of Science ®Google Scholar
• Chang JT, Lichtenstein GR. Drug insight: antagonists of tumor-necrosis factor-alpha in the treatment of inflammatory bowel disease. Nat Clin Pract Gastroenterol Hepatol 2006; 3:220 - 228
   PubMedGoogle Scholar
• Myers WA, Gottlieb AB, Mease P. Psoriasis and psoriatic arthritis: clinical features and disease mechanisms. Clin Dermatol 2006; 24:438 - 447
   PubMed Web of Science ®Google Scholar
• Nestorov I. Clinical pharmacokinetics of TNF antagonists: how do they differ?. Semin Arthritis Rheum 2005; 34:12 - 18
   PubMed Web of Science ®Google Scholar
• Kaymakcalan Z, Sakorafas P, Bose S, Scesney S, Xiong L, Hanzatian DK, et al. Comparisons of affinities, avidities and complement activation of adalimumab, infliximab, and etanercept in binding to soluble and membrane tumor necrosis factor. Clin Immunol 2009; 131:308 - 316
   PubMed Web of Science ®Google Scholar
• Keystone EC, Schiff MH, Kremer JM, Kafka S, Lovy M, DeVries T, et al. Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2004; 50:353 - 363
   PubMed Web of Science ®Google Scholar
• Immunex Corporation. Enbrel^® (etanercept) package insert 2000; Thousand Oaks, CA
   Google Scholar
• Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, et al. Radiographic, clinical and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum 2004; 50:1400 - 1411
   PubMed Web of Science ®Google Scholar
• Abbott Laboratories. Humira® (adalimumab) package insert 2009; Abbott Park, IL
   Google Scholar
• Maini R, St. Clair EW, Breedveld F, Furst D, Kalden J, Weisman M, et al. Infliximab (chimeric anti-tumour necrosis factor a monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. Lancet 1999; 354:1932 - 1939
   PubMed Web of Science ®Google Scholar
• Centocor. Remicade® (infliximab) package insert 2009; Malvern, PA
   Google Scholar
• Lefranc MP. IMGT-ONTOLOGY and IMGT databases, tools and Web resources for immunogenetics and immunoinformatics. Mol Immunol 2004; 40:647 - 660
   PubMed Web of Science ®Google Scholar
• Fishwild DM, O'Donnell SL, Bengoechea T, Hudson DV, Harding F, Bernhard SL, et al. High-avidity human IgG1 monoclonal antibodies from a novel strain of minilocus transgenic mice. Nature Biotechnology 1996; 14:845 - 851
   PubMed Web of Science ®Google Scholar
• Paleolog E. Target effector role of vascular endothelium in the inflammatory response: insights from the clinical trial of anti-TNFαlpha antibody in rheumatoid arthritis. Mol Pathol 1997; 50:225 - 233
   PubMedGoogle Scholar
• Keffer J, Probert L, Cazlaris H, Georgopoulos S, Kaslaris E, Kioussis D, et al. Transgenic mice expressing human tumour necrosis factor: a predictive genetic model of arthritis. EMBO J 1991; 10:4025 - 4031
   PubMed Web of Science ®Google 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. Arthritis Rheum 2008; 58:964 - 975
   PubMed Web of Science ®Google Scholar
• Weiner LM. Fully human therapeutic monoclonal antibodies. J Immunother 2006; 29:1 - 9
   PubMed Web of Science ®Google Scholar
• Lonberg N. Fully human antibodies from transgenic mouse and phage display platforms. Curr Opin Immunol 2008; 20:450 - 459
   PubMed Web of Science ®Google Scholar
• Shealy DJ, Visvanathan S. Anti-TNF antibodies: lessons from the past, roadmap for the future. Handb Exp Pharmacol 2008; 181:101 - 129
   PubMedGoogle Scholar
• Arora T, Padaki R, Liu L, Hamburger AE, Ellison AR, Stevens SR, et al. Differences in binding and effector functions between classes of TNF antagonists. Cytokine 2009; 45:124 - 131
   PubMed Web of Science ®Google Scholar
• Alexopoulou L, Kranidioti K, Xanthoulea S, Denis M, Kotanidou A, Douni E, et al. Transmembrane TNF protects mutant mice against intracellular bacterial infections, chronic inflammation and autoimmunity. Eur J Immunol 2006; 36:2768 - 2780
   PubMed Web of Science ®Google Scholar
• Dijstelbloem HM, van de Winkel JG, Kallenberg CG. Inflammation in autoimmunity: receptors for IgG revisited. Trends Immunol 2001; 22:510 - 516
   PubMed Web of Science ®Google Scholar
• Roopenian DS, Akilesh S. FcRn: the neonatal Fc receptor comes of age. Nat Rev Immunol 2007; 7:715 - 725
   PubMed Web of Science ®Google Scholar
• Scallon BJ, Moore MA, Trinh H, Knight DM, Ghrayeb J. Chimeric anti-TNFα monoclonal antibody cA2 binds recombinant transmembrane TNFα and activates immune effector functions. Cytokine 1995; 7:251 - 259
   PubMed Web of Science ®Google Scholar
• Catrina AI, Trollmo C, Klint EA, Engstrom M, Lampa J, Hermansson Y, et al. Evidence that anti-tumor necrosis factor therapy with both etanercept and infliximab induces apoptosis in macrophages, but not lymphocytes, in rheumatoid arthritis joints. Arthritis Rheum 2005; 52:61 - 72
   PubMed Web of Science ®Google Scholar
• Smeets TJ, Kraan MC, van Loon ME, Tak PP. Tumor necrosis factor alpha blockade reduces the synovial cell infiltrate early after initiation of treatment, but apparently not by induction of apoptosis in synovial tissue. Arthritis Rheum 2003; 48:2155 - 2162
   PubMed Web of Science ®Google Scholar
• Ringheaunu M, Daum F, Markowitz J, Levine J, Katz S, Lin X, et al. Effects of infliximab on apoptosis and reverse signaling of monocytes from healthy individuals and patients with Crohn's disease. Inflamm Bowel Dis 2004; 10:801 - 810
   PubMed Web of Science ®Google Scholar
• Wollin M, Abele S, Bruns S, Weyand M, Kalden JR, Ensminger SM, et al. Inhibition of TNFαlpha reduces transplant arteriosclerosis in a murine aortic transplant model. Transplant Int 2009; 22:342 - 349
   PubMed Web of Science ®Google Scholar
• Deveci F, Muz MH, Ilhan N, Kirkil G, Turgut T, Akpolat N. Evaluation of the anti-inflammatory effect of infliximab in a mouse model of acute asthma. Respirology 2008; 13:488 - 497
   PubMed Web of Science ®Google Scholar
• Shealy DJ, Wooley PH, Emmell E, Volk A, Rosenberg A, Treacy G, et al. Anti-TNFα antibody allows healing of joint damage in polyarthritic transgenic mice. Arthritis Res 2002; 4:7
   PubMedGoogle Scholar
• Zhou H, Jang H, Fleischmann RM, Bouman-Thio E, Xu Z, Marini JC, et al. Pharmacokinetics and safety of golimumab, a fully human anti-TNFαlpha monoclonal antibody, in subjects with rheumatoid arthritis. J Clin Pharmacol 2007; 47:383 - 396
   PubMed Web of Science ®Google Scholar
• Zhou H, Xu Z, Rahman MU, Wagner C, Pendley C, Han J, et al. Exposure-efficacy assessment of golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: application of population pharmacokinetic/pharmacodynamic modeling. Arthritis Rheum 2006; 54:5418
   Google Scholar
• Emery P, Gabay C, Kraan M, Gomez-Reino J. Evidence-based review of biologic markers as indicators of disease progression and remission in rheumatoid arthritis. Rheumatol Int 2007; 27:793 - 806
   PubMed Web of Science ®Google Scholar
• Taylor LD, Carmack CE, Huszar D, Higgins KM, Mashayekh R, Sequar G, et al. Human immunoglobulin transgenes undergo rearrangement, somatic mutation and class switching in mice that lack endogenous IgM. Int Immunology 1993; 6:579 - 591
   Web of Science ®Google Scholar
• Scallon BJ, Cai A, Solowski N, Rosenberg A, Song X-Y, Shealy D, et al. Binding and functional comparisons of two types of tumor necrosis factor antagonists. J Pharmacol Exp Ther 2002; 301:418 - 426
   PubMed Web of Science ®Google Scholar
• Perez C, Albert I, DeFay K, Zachariades N, Gooding L, Kriegler M. A nonsecretable cell surface mutant of tumor necrosis factor (TNF) kills by cell-to-cell contact. Cell 1990; 63:251 - 258
   PubMed Web of Science ®Google Scholar
• Miotla J, Maciewicz R, Kendrew J, Feldmann M, Paleolog E. Treatment with soluble VEGF receptor reduces disease severity in murine collagen-induced arthritis. Lab Invest 2000; 80:1195 - 1205
   PubMed Web of Science ®Google Scholar
• Douni E, Sfikakis PP, Haralambous S, Fernandes P, Kollias G. Attenuation of inflammatory polyarthritis in TNF transgenic mice by diarecein: comparative analysis with dexamethasone, methotrexate and anti-TNF protocols. Arthritis Res Ther 2004; 6:65 - 72
   PubMed Web of Science ®Google Scholar