Development of a human whole blood assay for prediction of cytokine release similar to anti-CD28 superagonists using multiplex cytokine and hierarchical cluster analysis

International Immunopharmacology

Volumn 11, Issue 11, 2011, Pages 1697-1705

  Walker, Mindi R ^a   Makropoulos, Dorie A ^a   Achuthanandam, Ram ^a   Van Arsdell, Scott ^b   Bugelski, Peter J ^a  

^a CENTOCOR INC   (United States)

^b Aushon Biosystems   (United States)

Author keywords

Cytokine storm; Monoclonal antibodies; Multivariate analysis; Protein A; Screening assays; Toxicology

Indexed keywords

ADALIMUMAB; ALEMTUZUMAB; BASILIXIMAB; CETUXIMAB; CYTOKINE; GAMMA INTERFERON; INTERLEUKIN 10; INTERLEUKIN 12P70; INTERLEUKIN 17; INTERLEUKIN 18; INTERLEUKIN 1BETA; INTERLEUKIN 2; INTERLEUKIN 4; INTERLEUKIN 6; INTERLEUKIN 8; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY BE 8; MONOCLONAL ANTIBODY CD28; PALIVIZUMAB; PANITUMUMAB; RITUXIMAB; TOCILIZUMAB; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG;

ANTIBODY RESPONSE; ARTICLE; BLOOD ANALYSIS; CLUSTER ANALYSIS; CONTROLLED STUDY; CYTOKINE RELEASE; CYTOKINE RELEASE SYNDROME; HUMAN; IMMUNOASSAY; NORMAL HUMAN; PRIORITY JOURNAL; PROTEIN IMMOBILIZATION; SCREENING TEST; SUPERNATANT;

ANTIBODIES, MONOCLONAL; ANTIGENS, CD28; CLUSTER ANALYSIS; CYTOKINES; DRUG TOXICITY; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNE SYSTEM DISEASES; PREDICTIVE VALUE OF TESTS; RECEPTORS, FC; SYNDROME;

EID: 80054978000     PISSN: 15675769     EISSN: 18781705     Source Type: Journal    
DOI: 10.1016/j.intimp.2011.06.001     Document Type: Article

References (53)

1. Common toxicity criteria (CTC) v2.0 1999 NCI Cancer Therapy Evaluation Program Bethesda, MD, USA
2. M. Walker, D. Makropoulos, R. Achuthanandam, and P.J. Bugelski Recent advances in the understanding of drug-mediated infusion reactions and cytokine release syndrome Curr Opin Drug Discov Devel 13 2010 124 135
3. C. Ferran, M. Dy, K. Sheehan, S. Merite, R. Schreiber, and P. Landais Inter-mouse strain differences in the in vivo anti-CD3 induced cytokine release Clin Exp Immunol 86 1991 537 543
4. E. Hod, C.M. Cadwell, J.S. Liepkalns, J.C. Zimring, S.A. Sokol, and D.A. Schirmer Cytokine storm in a mouse model of IgG-mediated hemolytic transfusion reactions Blood 112 2008 891 894
5. D. Hsu, J. Shi, M. Homola, T. Rowell, J. Moran, and D. Levitt A humanized anti-CD3 antibody, HuM291, with low mitogenic activity, mediates complete and reversible T-cell depletion in chimpanzees Transplantation 68 1999 545 554 (Pubitemid 29416632)
6. N. Müller, J. van den Brandt, F. Odoardi, D. Tischner, J. Herath, and A. Flügel A CD28 superagonistic antibody elicits 2 functionally distinct waves of T cell activation in rats J Clin Invest 118 2008 1405 1416 (Pubitemid 351500434)
7. A.A. Ansari, A. Mayne, D. Hunt, J.B. Sundstrom, and F. Villinger TH1/TH2 subset analysis. I. Establishment of criteria for subset identification in PBMC samples from nonhuman primates J Med Primatol 23 1994 102 107
8. D. Eastwood, L. Findlay, S. Poole, C. Bird, M. Wadhwa, and M. Moore Monoclonal antibody TGN1412 trial failure explained by species differences in CD28 expression on CD4+ effector memory T-cells Br J Pharmacol 161 2010 512 526
9. D. Nguyen, N. Hurtado-Ziola, P. Gagneux, and A. Varki Loss of siglec expression on T lymphocytes during human evolution Proc Natl Acad Sci USA 103 2006 7765 7770
10. R.J. Ober, C.G. Radu, V. Ghetie, and E.S. Ward Differences in promiscuity for antibody-FcRn interactions across species: implications for therapeutic antibodies Int Immunol 13 2001 1551 1559 (Pubitemid 33133882)
11. K.A. Rogers, F. Scinicariello, and R. Attanasio IgG Fc receptor III homologues in nonhuman primate species: genetic characterization and ligand interactions J Immunol 177 2006 3848 3856 (Pubitemid 44359919)
12. F.A. Zuckermann Extrathymic CD4/CD8 double positive T cells Vet Immunol Immunopathol 72 1999 55 66
13. P. Bugelski, R. Achuthanandam, R.J. Capocasale, G. Treacy, and E. Bouman-Thio Monoclonal antibody induced cytokine release syndrome: clinical aspects, the predictive value of nonclinical studies and the potential for in vitro screening Expert Rev Clin Immunol 5 2009 499 521
14. F. Luhder, Y. Huang, K.M. Dennehy, C. Guntermann, I. Muller, and E. Winkler Topological requirements and signaling properties of T cell-activating, anti-CD28 antibody superagonists J Exp Med 197 2003 955 966 (Pubitemid 36523193)
15. Z. Waibler, L.Y. Sender, C. Merten, R. Hartig, S. Kliche, and M. Gunzer Signaling signatures and functional properties of anti-human CD28 superagonistic antibodies PLoS One 3 2008 e1708
16. R. Stebbings, L. Findlay, C. Edwards, D. Eastwood, C. Bird, and D. North "Cytokine storm" in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics J Immunol 179 2007 3325 3331
17. A.R. Brasier, S. Victor, G. Boetticher, H. Ju, C. Lee, and E.R. Bleecker Molecular phenotyping of severe asthma using pattern recognition of bronchoalveolar lavage-derived cytokines J Allergy Clin Immunol 121 2008 30 37 e6
18. J.A. Patel, S. Nair, J. Grady, K. Revai, S. Victor, and A.R. Brasier Systemic cytokine response profiles associated with respiratory virus-induced acute otitis media Pediatr Infect Dis J 28 2009 407 411
19. P. Szodoray, P. Alex, V. Dandapani, B. Nakken, J. Pesina, and X. Kim Apoptotic effect of rituximab on peripheral blood B cells in rheumatoid arthritis Scand J Immunol 60 2004 209 218 (Pubitemid 38943069)
20. H.J. van den Ham, W. de Jager, J.W. Bijlsma, B.J. Prakken, and R.J. de Boer Differential cytokine profiles in juvenile idiopathic arthritis subtypes revealed by cluster analysis Rheumatology (Oxford) 48 2009 899 905
21. J. Gollub, and G. Sherlock Clustering microarray data Methods Enzymol 411 2006 194 213
22. B. Genser, P.J. Cooper, M. Yazdanbakhsh, M.L. Barreto, and L.C. Rodrigues A guide to modern statistical analysis of immunological data BMC Immunol 8 2007 27
23. Y. Ben-Neriah, I. Alkalay, A. Yaron, A. Hatzubai, and S. Jung Signalling intermediates of CD28 Res Immunol 146 1995 154 158
24. M.K. Jenkins, and J.G. Johnson Molecules involved in T-cell costimulation Curr Opin Immunol 5 1993 361 367 (Pubitemid 23197447)
25. I. Kariv, A. Truneh, and R.W. Sweet Analysis of the site of interaction of CD28 with its counter-receptors CD80 and CD86 and correlation with function J Immunol 157 1996 29 38 (Pubitemid 26190529)
26. M. Moody, S. Van Arsdell, K.P. Murphy, S.F. Orencole, and C. Burns Arraybased ELISAs for high-throughput analysis of human cytokines Biotechniques 31 2001 186 194 (Pubitemid 32645924)
27. J. Mulligan, R. Shively, and C.L. O'Day Elucidaion of cytokine storm: the effect of in vitro antibody immobilization methods on cytokine secretion in a cell-based assay Abstr Toxicologist 108 S1 2009 365
28. M.G. Wing, T. Moreau, J. Greenwood, R.M. Smith, G. Hale, and J. Isaacs 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 1996 2819 2826 (Pubitemid 26427411)
29. R.M. Giusti, K.A. Shastri, M.H. Cohen, P. Keegan, and R. Pazdur FDA drug approval summary: panitumumab (Vectibix) Oncologist 12 2007 577 583 (Pubitemid 350012121)
30. M. Wing, H. Waldmann, J. Isaacs, D. Compston, and G. Hale Ex-vivo whole blood cultures for predicting cytokine-release syndrome: dependence on target antigen and antibody isotype Ther Immunol 2 1995 183 190 (Pubitemid 27433380)
31. Runnels HA, Weber GL, Min J, Kudlacz EM, Zobel JF, Donovan CB, et al. PF-03475952: a potent and neutralizing fully human anti-CD44 antibody for therapeutic applications in inflammatory diseases. Adv Ther 2010;27:168-80.
32. L. Findlay, D. Eastwood, R. Stebbings, G. Sharp, Y. Mistry, and C. Ball Improved in vitro methods to predict the in vivo toxicity in man of therapeutic monoclonal antibodies including TGN1412 J Immunol Methods 352 2009 1 12
33. V. Appay, S. Reynard, V. Voelter, P. Romero, D.E. Speiser, and S. Leyvraz Immuno-monitoring of CD8+ T cells in whole blood versus PBMC samples J Immunol Methods 309 2006 192 199 (Pubitemid 43190815)
34. P. Renzi, and L.C. Ginns Analysis of T cell subsets in normal adults. Comparison of whole blood lysis technique to Ficoll-Hypaque separation by flow cytometry J Immunol Methods 98 1987 53 56 (Pubitemid 17078094)
35. Chen J, Bruns AH, Donnelly HK, Wunderink RG. Comparative in vitro stimulation with lipopolysaccharide to study TNFalpha gene expression in fresh whole blood, fresh and frozen peripheral blood mononuclear cells. J Immunol Methods 2010;357:33-7.
36. G. Li Pira, F. Ivaldi, P. Moretti, M. Risso, G. Tripodi, and F. Manca Validation of a miniaturized assay based on IFNg secretion for assessment of specific T cell immunity J Immunol Methods 355 2010 68 75
37. D. De Groote, P.F. Zangerle, Y. Gevaert, M.F. Fassotte, Y. Beguin, and F. Noizat-Pirenne Direct stimulation of cytokines (IL-1 beta, TNF-alpha, IL-6, IL-2, IFN-gamma and GM-CSF) in whole blood. I. Comparison with isolated PBMC stimulation Cytokine 4 1992 239 248
38. U. Elsasser-Beile, S. von Kleist, and H. Gallati Evaluation of a test system for measuring cytokine production in human whole blood cell cultures J Immunol Methods 139 1991 191 195
39. I. Mayringer, M. Reindl, and T. Berger A critical comparison of frequently used methods for the analysis of tumor necrosis factor-alpha expression by human immune cells J Immunol Methods 235 2000 33 40 (Pubitemid 30089781)
40. J. Deisenhofer Crystallographic refinement and atomic models of a human Fc fragment and its complex with fragment B of protein A from Staphylococcus aureus at 2.9- and 2.8-A resolution Biochemistry 20 1981 2361 2370 (Pubitemid 11089772)
41. J. Deisenhofer, T.A. Jones, R. Huber, J. Sjodahl, and J. Sjoquist Crystallization, crystal structure analysis and atomic model of the complex formed by a human Fc fragment and fragment B of protein A from Staphylococcus aureus Hoppe Seylers Z Physiol Chem 359 1978 975 985 (Pubitemid 9060557)
42. J.E. Butler, L. Ni, W.R. Brown, K.S. Joshi, J. Chang, and B. Rosenberg The immunochemistry of sandwich ELISAs-VI. Greater than 90% of monoclonal and 75% of polyclonal anti-fluorescyl capture antibodies (CAbs) are denatured by passive adsorption Mol Immunol 30 1993 1165 1175
43. T. Klonisch, G. Panayotou, P. Edwards, A.M. Jackson, P. Berger, and P.J. Delves Enhancement in antigen binding by a combination of synergy and antibody capture Immunology 89 1996 165 171 (Pubitemid 26340117)
44. T. Ikeda, Y. Hata, K. Ninomiya, Y. Ikura, K. Takeguchi, and S. Aoyagi Oriented immobilization of antibodies on a silicon wafer using Si-tagged protein A Anal Biochem 385 2009 132 137
45. J. Turkova Oriented immobilization of biologically active proteins as a tool for revealing protein interactions and function J Chromatogr B Biomed Sci Appl 722 1999 11 31 (Pubitemid 29142500)
46. M.A. Tufano, G. Cipollaro de l'Ero, R. Ianniello, M. Galdiero, and F. Galdiero Protein A and other surface components of Staphylococcus aureus stimulate production of IL-1 alpha, IL-4, IL-6, TNF and IFN-gamma Eur Cytokine Netw 2 1991 361 366
47. Sphero Technical Note. Protein A Coated Paricles. Rev C 082107 ed. Lake Forest, Illinois.
48. E. Darcy, P. Leonard, J. Fitzgerald, M. Danaher, and R. O'Kennedy Purification of antibodies using affinity chromatography Methods Mol Biol 2011 369 382
49. P.M. Cardarelli, M. Quinn, D. Buckman, Y. Fang, D. Colcher, and D.J. King Binding to CD20 by anti-B1 antibody or F(ab')(2) is sufficient for induction of apoptosis in B-cell lines Cancer Immunol Immunother 51 2002 15 24 (Pubitemid 34158519)
50. P.A. Carpenter, S. Pavlovic, J.Y. Tso, O.W. Press, T. Gooley, and X.Z. Yu Non-Fc receptor-binding humanized anti-CD3 antibodies induce apoptosis of activated human T cells J Immunol 165 2000 6205 6213
51. D. Xu, M.L. Alegre, S.S. Varga, A.L. Rothermel, A.M. Collins, and V.L. Pulito In vitro characterization of five humanized OKT3 effector function variant antibodies Cell Immunol 200 2000 16 26 (Pubitemid 30170076)
52. V. Baudouin, A. Crusiaux, E. Haddad, L. Schandene, M. Goldman, and C. Loirat Anaphylactic shock caused by immunoglobulin E sensitization after retreatment with the chimeric anti-interleukin-2 receptor monoclonal antibody basiliximab Transplantation 76 2003 459 463 (Pubitemid 37013247)
53. C.H. Chung, B. Mirakhur, E. Chan, Q.T. Le, J. Berlin, and M. Morse Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose N Engl J Med 358 2008 1109 1117 (Pubitemid 351398485)