Apoptosis and the FLIP and NF-kappa B proteins as pharmacodynamic criteria for biosimilar TNF-alpha antagonists

Biologics: Targets and Therapy

Volumn 8, Issue , 2014, Pages 211-220

  Urbano, Paulo César Martins ^a   Soccol, Vanete Thomaz ^a   Azevedo, Valderilio Feijó ^a  

^a FEDERAL UNIVERSITY OF PARANÁ   (Brazil)

Author keywords

Anti TNF drugs; Apoptosis; FLIP; NF B; Rheumatoid arthritis

Indexed keywords

ADALIMUMAB; BIOSIMILAR AGENT; CASPASE 3; CASPASE 8; CERTOLIZUMAB PEGOL; CYCLOPHOSPHAMIDE; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; FLICE INHIBITORY PROTEIN; GOLIMUMAB; HYDROXYCHLOROQUINE; IMMUNOGLOBULIN ENHANCER BINDING PROTEIN; IMMUNOGLOBULIN FC FRAGMENT; INFLIXIMAB; MESSENGER RNA; METHOTREXATE; SALAZOSULFAPYRIDINE; TUMOR NECROSIS FACTOR ALPHA; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; TUMOR NECROSIS FACTOR RECEPTOR 1;

ANKYLOSING SPONDYLITIS; ANTIINFLAMMATORY ACTIVITY; APOPTOSIS; ARTHRITIS; COMBINATION CHEMOTHERAPY; CROHN DISEASE; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG STRUCTURE; FLIP GENE; HUMAN; JUVENILE RHEUMATOID ARTHRITIS; MONOTHERAPY; NONHUMAN; OSTEOARTHRITIS; PATENT; PROTEIN EXPRESSION; PSORIASIS; PSORIATIC ARTHRITIS; REVIEW; RHEUMATOID ARTHRITIS; TREATMENT OUTCOME; ULCERATIVE COLITIS;

EID: 84905500301     PISSN: 11775475     EISSN: 11775491     Source Type: Journal    
DOI: 10.2147/BTT.S57253     Document Type: Review

References (72)

1. Gaur U, Aggarwal BB. Regulation of proliferation, survival and apoptosis by members of the TNF superfamily. Biochem Pharmacol. 2003;66(8):1403-1408.
2. Kaushansky K, Broudy VC, Harlan JM, Adamson JW. Tumor necrosis factoralpha and tumor necrosis factor-beta (lymphotoxin) stimulate the production of granulocyte-macrophage colony-stimulating factor, macrophage colonystimulating factor, and IL-1 in vivo. J Immunol. 1988;141(10):3410-3415.
3. Brennan FM, Chantry D, Jackson A, Maini R, Feldmann M. Inhibitory effect of TNF alpha antibodies on synovial cell interleukin-1 production in rheumatoid arthritis. Lancet. 1989;2(8657):244-247.
4. Butler DM, Maini RN, Feldmann M, Brennan FM. Modulation of proinflammatory cytokine release in rheumatoid synovial membrane cell cultures. Comparison of monoclonal anti TNF-alpha antibody with the interleukin-1 receptor antagonist. Eur Cytokine Netw. 1995;6(4):225-230.
5. Van Dullemen HM, Van Deventer SJ, Hommes DW, et al. Treatment of Crohn's disease with anti-tumor necrosis factor chimeric monoclonal antibody (cA2). Gastroenterology. 1995;109(1):129-135.
6. Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther. 2008;117(2):244-279.
7. Schellekens H. How similar do "biosimilars" need to be? Nat Biotechnol. 2004;22(11):1357-1359.
8. Catrina AI, Ulfgren AK, Lindblad S, Grondal L, Klareskog L. Low levels of apoptosis and high FLIP expression in early rheumatoid arthritis synovium. Ann Rheum Dis. 2002;61(10):934-936.
9. Micheau O, Lens S, Gaide O, Alevizopoulos K, Tschopp J. NF-kappaB signals induce the expression of c-FLIP. Mol Cell Biol. 2001;21(16):5299-5305.
10. Wang CY, Mayo MW, Korneluk RG, Goeddel DV, Baldwin AS Jr. NF-kappaB antiapoptosis: induction of TRAF1 and TRAF2 and c-IAP1 and c-IAP2 to suppress caspase-8 activation. Science. 1998;281(5383):1680-1683.
11. Azevedo VF. Are we prepared to prescribe biosimilars? Rev Bras Reumatol. 2010;50(3):221-224.
12. McCamish M, Woollett G. The state of the art in the development of biosimilars. Clinical pharmacology and Therapeutics. 2012; 91(3):405-417.
13. Calvo B, Zúñiga L. Medicamentos Biotecnológicos: Requisitos Exigidos para el Desarrollo y Aprobación de Biosimilares. [Biological MedicinalProducts: Requirements for the Development and Approval of Biosimilars]. Información tecnológica. 2010;21(6):125-132. Spanish.
14. Cai XY, Gouty D, Baughman S, Ramakrishnan M, Cullen C. Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development. Bioanalysis. 2011;3(5):535-540.
15. FDA Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.
16. European Medicines Agency Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues.
17. Pinto VF. Estudos clínicos de não-inferioridade: fundamentos e controvérsias. [Non-inferiority clinical trials: concepts and issues]. J Vasc Bras. 2010;9(3):145-151. Portuguese.
18. Makrygiannakis D, Catrina AI. Apoptosis as a mechanism of action of tumor necrosis factor antagonists in rheumatoid arthritis. J Rheumatol. 2012;39(4):679-685.
19. Atreya R, Zimmer M, Bartsch B, et al. Antibodies against tumor necrosis factor (TNF) induce T-cell apoptosis in patients with inflammatory bowel diseases via TNF receptor 2 and intestinal CD14+ macrophages. Gastroenterology. 2011;141(6):2026-2038.
20. Catrina AI, Trollmo C, af Klint E, 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: extended report. Arthritis Rheum. 2005;52(1):61-72.
21. Lügering A, Schmidt M, Lügering N, Pauels HG, Domschke W, Kucharzik T. Infliximab induces apoptosis in monocytes from patients with chronic active Crohn's disease by using a caspase-dependent pathway. Gastroenterology. 2001;121(5):1145-1157.
22. Micheau O, Tschopp J. Induction of TNF receptor I-mediated apoptosis via two sequential signaling complexes. Cell. 2003;114(2): 181-190.
23. Ottonello L. Synovial fluid from patients with rheumatoid arthritis inhibits neutrophil apoptosis: role of adenosine and proinflammatory cytokines. Rheumatology (Oxford). 2002;41(11):1249-1260.
24. Angermeier M, Eckardt-Schupp F, Moertl S. A novel function of Ubc13 in TNFR1 receptor activation. Cell Signal. 2010;22(9): 1388-1396.
25. Bogliolo BFG: Patologia Geral. [General Pathology]. 4a edition. Rio de Janeiro: Guanabara Koogan; 2009:378. Portuguese.
26. Enbrel (Etanercept) [prescribing information]. Immunex Corporation; 2007.
27. Remicade (infliximab) [prescribing information]. Centocor I; 2006.
28. Humira (adalimumab) [prescribing information]. Laboratories A; 2007.
29. Cimzia (Certolizumab pegol) [prescribing information]. UCB I; 2009.
30. Simponi (Golimumab) [prescribing information]. Centocor I; 2009.
31. Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007;357(3):239-250.
32. Voulgari PV. Golimumab: a new anti-TNF-alpha agent for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Expert Rev Clin Immunol. 2010;6(5):721-733.
33. Goel N, Stephens S. Certolizumab pegol. MAbs. 2010;2(2):137-147.
34. Pappas DA, Bathon JM, Hanicq D, Yasothan U, Kirkpatrick P. Golimumab. Nature reviews Drug Discovery. 2009;8:695-696.
35. Schreiber S. Certolizumab pegol for the treatment of Crohn's disease. Therap Adv Gastroenterol. 2011;4(6):375-389.
36. Wong M, Ziring D, Korin Y, et al. TNFalpha blockade in human diseases: mechanisms and future directions. Clin Immunol. 2008;126(2):121-136.
37. Shen C, Van Assche G, Rutgeerts P, Ceuppens JL. Caspase activation and apoptosis induction by adalimumab: demonstration in vitro and in vivo in a chimeric mouse model. Inflamm Bowel Dis. 2006;12(1):22-28.
38. Horiuchi T, Mitoma H, Harashima S, Tsukamoto H, Shimoda T. Transmembrane TNF-alpha: structure, function and interaction with anti-TNF agents. Rheumatology (Oxford). 2010;49(7):1215-1228.
39. Shealy D, Cai A, Staquet K, et al. Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor alpha. MAbs. Epub July 1, 2010;2(4).
40. Van den Brande JMH, Braat H, Van den Brink GR, et al. Infliximab but not etanercept induces apoptosis in lamina propria T-lymphocytes from patients with Crohn's disease. Gastroenterology. 2003;124(7):1774-1785.
41. Bourne T, Fossati G, Nesbitt A. A PEGylated Fab' fragment against tumor necrosis factor for the treatment of Crohn disease: exploring a new mechanism of action. BioDrugs. 2008;22(5):331-337.
42. Nesbitt A, Fossati G, Bergin M, et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis. 2007;13(11): 1323-1332.
43. Di Sabatino A, Ciccocioppo R, Cinque B, et al. Defective mucosal T cell death is sustainably reverted by infliximab in a caspase dependent pathway in Crohn's disease. Gut. 2004;53(1):70-77.
44. Ohshima S, Mima T, Sasai M, et al. Tumour necrosis factor alpha (TNF-alpha) interferes with Fas-mediated apoptotic cell death on rheumatoid arthritis (RA) synovial cells: a possible mechanism of rheumatoid synovial hyperplasia and a clinical benefit of anti-TNF-alpha therapy for RA. Cytokine. 2000;12(3):281-288.
45. Meusch U, Rossol M, Baerwald C, Hauschildt S, Wagner U. Outside-toinside signaling through transmembrane tumor necrosis factor reverses pathologic interleukin-1beta production and deficient apoptosis of rheumatoid arthritis monocytes. Arthritis Rheum. 2009;60(9):2612-2621.
46. Van Deventer SJ. Transmembrane TNF-alpha, induction of apoptosis, and the efficacy of TNF-targeting therapies in Crohn's disease. Gastroenterology. 2001;121(5):1242-1246.
47. Mitoma H, Horiuchi T, Hatta N, et al. Infliximab induces potent antiinflammatory responses by outside-to-inside signals through transmembrane TNF-alpha. Gastroenterology. 2005;128(2):376-392.
48. Pattacini L, Boiardi L, Casali B, Salvarani C. Differential effects of anti-TNF-alpha drugs on fibroblast-like synoviocyte apoptosis. Rheumatology (Oxford). 2010;49(3):480-489.
49. Taylor PC, Peters AM, Paleolog E, et al. Reduction of chemokine levels and leukocyte traffic to joints by tumor necrosis factor alpha blockade in patients with rheumatoid arthritis. Arthritis Rheum. 2000;43(1):38-47.
50. Herman S, Zurgil N, Machlav S, et al. Distinct effects of anti-tumor necrosis factor combined therapy on TH1/TH2 balance in rheumatoid arthritis patients. Clin Vaccine Immunol. 2011;18(7):1077-1082.
51. Aravena O, Pesce B, Soto L, et al. Anti-TNF therapy in patients with rheumatoid arthritis decreases Th1 and Th17 cell populations and expands IFN-γ-producing NK cell and regulatory T cell subsets. Immunobiology. 2011;216(12):1256-1263.
52. Vos ACW, Wildenberg ME, Duijvestein M, Verhaar AP, Van den Brink GR, Hommes DW. Anti-tumor necrosis factor-α antibodies induce regulatory macrophages in an Fc region-dependent manner. Gastroenterology. 2011;140(1):221-230.
53. Kaymakcalan Z, Sakorafas P, Bose S, 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(2):308-316.
54. Fries W, Muja C, Crisafulli C, et al. Infliximab and etanercept are equally effective in reducing enterocyte APOPTOSIS in experimental colitis. Int J Med Sci. 2008;5(4):169-180.
55. Eder P, Lykowska-Szuber L, Krela-Kazmierczak I, Stawczyk-Eder K, Zabel M, Linke K. The influence of infliximab and adalimumab on the expression of apoptosis-related proteins in lamina propria mononuclear cells and enterocytes in Crohn's disease an immunohistochemical study. J Crohns Colitis. 2013;7(9):706-716.
56. Smith MD, Weedon H, Papangelis V, Walker J, Roberts-Thomson PJ, Ahern MJ. Apoptosis in the rheumatoid arthritis synovial membrane: modulation by disease-modifying anti-rheumatic drug treatment. Rheumatology (Oxford). 2010;49(5):862-875.
57. Oakley F, Meso M, Iredale JP, et al. Inhibition of inhibitor of kappaB kinases stimulates hepatic stellate cell apoptosis and accelerated recovery from rat liver fibrosis. Gastroenterology. 2005;128(1):108-120.
58. Kim WU, Yoo S-A, Min S-Y, et al. Hydroxychloroquine potentiates Fas-mediated apoptosis of rheumatoid synoviocytes. Clin Exp Immunol. 2006;144(3):503-311.
59. Nielsen CH, Albertsen L, Bendtzen K, Baslund B. Methotrexate induces poly(ADP-ribose) polymerase-dependent, caspase 3-independent apoptosis in subsets of proliferating CD4+ T cells. Clin Exp Immunol. 2007;148(2):288-295.
60. Strauss G, Osen W, Debatin KM. Induction of apoptosis and modulation of activation and effector function in T cells by immunosuppressive drugs. Clin Exp Immunol. 2002;128(2):255-266.
61. Malaviya R, Sun Y, Tan JK, et al. Etanercept induces apoptosis of dermal dendritic cells in psoriatic plaques of responding patients. J Am Acad Dermatol. 2006;55(4):590-597.
62. Goedkoop AY, Kraan MC, Picavet DI, et al. Deactivation of endothelium and reduction in angiogenesis in psoriatic skin and synovium by low dose infliximab therapy in combination with stable methotrexate therapy: a prospective single-centre study. Arthritis Research and Therapy. 2004;6(4):R326-R334.
63. Perlman H, Pagliari LJ, Nguyen N, Bradley K, Liu H, Pope RM. The Fas-FasL death receptor and PI3K pathways independently regulate monocyte homeostasis. Eur J Immunol. 2001;31(8):2421-2430.
64. Palao G, Santiago B, Galindo M, Payá M, Ramirez JC, Pablos JL. Down-regulation of FLIP sensitizes rheumatoid synovial fibroblasts to Fas-mediated apoptosis. Arthritis Rheum. 2004;50(9):2803-2810.
65. Schedel J, Gay RE, Kuenzler P, et al. FLICE-inhibitory protein expression in synovial fibroblasts and at sites of cartilage and bone erosion in rheumatoid arthritis. Arthritis Rheum. 2002;46(6):1512-1518.
66. Wu FX, Wu LJ, Luo XY, et al. Expression of FLICE-inhibitory protein in synovial tissue and its association with synovial inflammation in juvenile idiopathic arthritis. Chin Med Sci J. 2010;25(1):20-26.
67. Bai S, Liu H, Chen K-H, et al. NF-kappaB-regulated expression of cellular FLIP protects rheumatoid arthritis synovial fibroblasts from tumor necrosis factor alpha-mediated apoptosis. Arthritis Rheum. 2004;50(12):3844-3855.
68. Hammaker D, Sweeney S, Firestein GS. Signal transduction networks in rheumatoid arthritis. Ann Rheum Dis. 2003;62(Suppl 2):86-89.
69. Pagliari LJ, Perlman H, Liu H, Pope RM. Macrophages require constitutive NF-kappaB activation to maintain A1 expression and mitochondrial homeostasis. Mol Cell Biol. 2000;20(23): 8855-8865.
70. Zhang HG, Hyde K, Page GP, et al. Novel tumor necrosis factor alpha-regulated genes in rheumatoid arthritis. Arthritis Rheum. 2004;50(2):420-431.
71. Collantes E, Valle Blázquez M, Mazorra V, Macho A, Aranda E, Muñoz E. Nuclear factor-kappa B activity in T cells from patients with rheumatic diseases: a preliminary report. Ann Rheum Dis. 1998;57(12): 738-741.
72. Fujisawa K, Aono H, Hasunuma T, Yamamoto K, Mita S, Nishioka K. Activation of transcription factor NF-kappa B in human synovial cells in response to tumor necrosis factor alpha. Arthritis Rheum. 1996;39(2):197-203.