The effect of intravenous administration of a chimeric anti-IgE antibody on serum IgE levels in atopic subjects: Efficacy, safety, and pharmacokinetics

Journal of Clinical Investigation

Volumn 99, Issue 5, 1997, Pages 879-887

  Corne, Jonathan ^a   Djukanovic, Ratko ^a   Thomas, Lynette ^a   Warner, Jane ^a   Botta, Luigi ^b   Grandordy, Beatrice ^b   Gygax, Daniel ^b   Heusser, Christoph ^b   Patalano, Francesco ^b   Richardson, William ^b   Kilchherr, Erich ^b   Staehelin, Theophil ^b   Davis, Frances ^c   Gordon, Wayne ^c   Sun, Lee ^c   Liou, Ruey ^c   Wang, George ^c   Chang, Tse Wen ^c   Holgate, Stephen ^a  

^a SOUTHAMPTON GENERAL HOSPITAL   (United Kingdom)

^b CIBA GEIGY LTD   (Switzerland)

^c Tanox Biosystems Inc   (United States)

Author keywords

atopic hypersensitivity; chimeric proteins; IgE; monoclonal antibodies; rhinitis

Indexed keywords

CGP 51901; IMMUNOGLOBULIN E ANTIBODY; UNCLASSIFIED DRUG;

ADULT; ARTICLE; ATOPY; CHIMERA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG ELIMINATION; DRUG HALF LIFE; GRASS POLLEN; HUMAN; HUMAN EXPERIMENT; IMMUNOGLOBULIN BLOOD LEVEL; INTRAVENOUS DRUG ADMINISTRATION; MALE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

EID: 17644441947     PISSN: 00219738     EISSN: None     Source Type: Journal    
DOI: 10.1172/JCI119252     Document Type: Article

References (44)

1. Gergen, P., and K. Weiss. 1994. Epidemiology of asthma. In Asthma and Rhinitis. S.T. Holgate and W.W. Busse, editors. Blackwell Scientific, Cambridge, MA. 15-31.
2. Weis, K.B., P.J. Gergen, and T.A. Hodgson. 1992. An economic evaluation of asthma in the United States. N. Engl. J. Med. 326:862-866.
3. Burrows, B., F.D. Martinez, M. Holonen, R.A. Barbee, and M.G. Cline. 1989. Association of asthma with serum IgE levels and skin test reactivity to allergens. N. Engl. J. Med. 320:271-277.
4. Sears, M.R., B. Burrows, E.M. Flannery, G.P. Herbison, C.J. Hewitt, and M.D. Holdaway. 1991. Relation between airway responsiveness and serum IgE in children with asthma and in apparently normal children. N. Engl. J. Med. 325: 1067-1071.
5. Sunyer, J., A. Munoz, and Spanish Group of the European Asthma Study. 1996. Concentration of Methacholine for bronchial responsiveness according to symptoms, smoking, and Immunoglobulin E in a population based study in Spain. Am. J. Respir. Crit. Care Med. 153:1273-1279.
6. Pollart, S., M. Chapman, G. Fiocco, G. Rose, and A. Plaits-Mills. 1989. Epidemiology of acute asthma: IgE anlibodies to common inhalant allergens as a risk factor for emergency room visits. J. Allergy Clin. Immunol. 83:875-882.
7. Lichtenstein, L., K. Ishizaka, P. Norman, A. Sobotka, and B. Hill. 1973. IgE antibody measurements in ragweed hay fever. J. Clin. Invest. 52:472-482.
8. Naclerio, R., N. Adkinson, Jr, P. Creticos, F. Baroody, R. Hamilton, and P. Norman. 1993. Intranasal steroids inhibit seasonal increases in ragweed-specific immunoglobulin E antibodies. J. Allergy Clin. Immunol. 92:717-721.
9. Bradding, P., J. Roberts, K. Britten, S. Montefort, R. Djukanovic, R. Mueller, C. Heusser, P. Howarth, and S. Holgate. 1994. IL-4,-5,-6 and TNFα in normal and asthmatic airways: evidence of the human mast cell as a source of these cytokines. Am. J. Respir. Cell Mol. Biol. 10:471-480.
10. Bradding, P. Feather, P. Howarth, R. Mueller, J. Roberts, K. Britten, J. Bews, T. Hunt, Y. Okayama, C. Heusser, G. Bullock, M. Church, and S. Holgate. 1992. Interleukin 4 is localized to and released by human mast cells. J. Exp. Med. 176:1381-1386.
11. Bradding, P., R. Mediwake, I. Feather, J. Madden, M. Church, S. Holgate, and P. Howarth. 1995. TNFα is localized to nasal mucosal mast cells and is released in acute rhinitis. Clin. Exp. Allergy. 25:406-415.
12. Okayama, Y., C. Petit-Frere, O. Kassel, A. Semper, D. Quint, M.J. Tunon-de-Lara, P. Bradding, S.T. Holgate, and M.K. Church. 1995. IgE-dependent expression of mRNA for IL-4 and IL-5 in human lung mast cells. J. Immunol. 155:1796-1808.
13. Maurer, D., C. Ebner, B. Reininger, E. Fiebiger, D. Krall, J. Kinet, and G. Stingl. 1995. The high affinity IgE receptor (Fc∈R1) mediates IgE-dependent allergen presentation. J. Immunol. 154:6285-6290.
14. Reischl, I., N. Corvaia, F. Effenberger, B. Wolff-Winiski, E. Kromer, and G. Mudde. 1996. Function and regulation of Fc∈R1 expression on monocytes from non-atopic donors. Clin. Exp. Allergy. 26:630-641.
15. Pirron, U., T. Schlunk, J. Prinz, and E. Rieber. 1990. IgE dependent antigen focusing by human B lymphocytes is mediated by the low affinity receptor for IgE. Eur. J. Immunol. 20:1547-1551.
16. Coyle, A., K. Wagner, C. Bertrand, S. Tsuyuki, J. Bews, and C. Heusser. 1996. Central role of Immunoglobulin (Ig) E in the induction of lung eosinophil infiltration and T helper 2 cell cytokine production: Inhibition by a non-anaphylactogenic anti-IgE antibody. J. Exp. Med. 183:1303-1310.
17. Brusselle, G., J. Kips, J. Tavernier, J. Van der Heyden, C. Cuvelier, R. Pauwels, and H. Bluethmann. 1994. Attenuation of allergic airway inflammation in IL-4 deficient mice. Clin. Exp. Allergy. 24:73-80.
18. Davis, F., L. Gossetl, K. Pinkston, R. Liou, L. Sun, Y. Kim, N. Chang, K. Wagner, J. Bews, V. Brinkman, H. Towbin, N. Subramanian, and C. Heusser. 1993. Can anti-IgE be used to treat allergy. Springer Semin. Immunopathol. 15: 51-73.
19. Khazaeli, M., M. Saleh, T. Liu, R. Meredith, R. Wheeler, T. Baker, D. King, D. Seeher, L. Allen, K. Rogers, D. Colcher, J. Schlom, D. Shochat, and A. LoBuglio. 1991. Pharmakokinetics and immune response of 131 I-chimaeric mouse/human B72-3 (human gamma 4) monoclonal antibody in humans. Cancer Res. 51:5461-5466.
20. Bruggemann, M., G. Winter, H. Waldmann, and M. Neuberger. 1989. The immunogenicity of chimeric antibodies. J. Exp Med. 170:2153-2157.
21. Roberts, S., J. Cheetham, and A. Rees. 1987. Generation of an antibody with enhanced affinity and specificity for its antigen by protein engineering. Nature (Lond.). 328:731-734.
22. Malling, H.-J. Methods of skin testing. Eur. J. Allergy Clin. Immunol. 48s:55-56.
23. D'Ambrosio, S., R. Gibson-D'Ambrosio, and R. Trewyn. 1991. An enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of the tumor marker 1-methylinosine in human urine. Clin. Chim. Acta. 199: 119-128.
24. Bodmer, D., L. Tiefenauer, and R. Andres. 1989. Antigen-versus antibody-immobolized ELISA procedures based on a biotinyl-estradiol conjugate. J. Steroid Biochem. Mol. Biol. 33:1161-1166.
25. Warner, J., A. Reshef, and D.J. MacGlashan. 1987. A rapid technique for the purification of human basophils. J. Immunol. Methods. 105:107-110.
26. Siraganian, R. 1974. An automated continuous flow system for the extraction and fluorometric determination of histamine. Annal. Biochem. 57:283-287.
27. Gibaldi, M., and D. Perrier. 1982. Pharmacokinetics. 2nd ed. Marcel Dekker Inc., New York. 352 pp.
28. Helm, B., P. Marsh, D. Vercelli, E. Padlan, H. Gould, and R. Geha. 1988. The mast cell binding site on human immunoglobulin E. Nature (Lond.). 311:180-183.
29. Klein, J. 1982. Immunology. The Science of Self Non-Self Discrimination. John Wiley and Sons, New York. 1284 pp.
30. Solomen, A., T. Waldmann, and J. Fahey. 1963. Metabolism of normal 6.6 γ globulin in normal subjects and in patients with macroglobulinemia and multiple myeloma. J. Lab. Clin. Med. 62:1-17.
31. LoBuglio, A., R. Wheeler, J. Trang, A. Haynes, K. Rogers, E. Harvey, L. Sun, J. Ghrayeb, and M. Khazaeli. 1989. Mouse/human chimeric monoclonal antibody in man: Kinetics and immune response. Proc. Natl. Acad. Sci. USA. 86:4220-4224.
32. Morell, A., W. Terry, and T. Waldmann. 1970. Metabolic properties of IgG subclasses in man. J Clin. Invest. 49:673-680.
33. Siraganian, R. 1988. Mast cells and basophils. In Inflammation: Basic Principles and Clinical Correlates. J. Gallin, I. Goldstein, and R. Snyderman, editors. Raven Press, New York. 513-542.
34. Khazaeli, M., M. Saleh, T. Liu, R. Meredith, R. Wheeler, T. Baker, D. King, D. Secher, L. Allen, K. Rogers, D. Colcher, J. Schlom, D. Schochat, and A. LoBuglio. 1991. Pharmacokinetics and immune response of 131I-chimeric mouse/human B72.3 (human γ4) monoclonal antibody in humans. Cancer Res. 51:5461-5466.
35. Contreras, C., A. Orozco, P. Sanchez, G. Onega, and N. Bianco. 1982. Physiological aspects of circulating immune complexes in the normal population. Clin. Exp. Immunol. 48:693-699.
36. Rihet, P., C. Demeure, A. Bourgois, A. Prata, and A. Dessein. 1991. Evidence for an association between human resistance to Schistosoma mansoni and high anti-larval IgE levels. Eur. J. Immunol. 21:2679-2686.
37. Velge-Roussel, F., C. Auriault, M. Damonneville, and A. Capron. 1991. Functional analysis of a T cell line specific for antiidiotypic antibodies to a Schistosoma mansoni protective epitope. II. Induction of protective immunity in experimental rat schistosomiasis. J. Immunol. 147:3967-3972.
38. Watanabe, N., K. Katakura, A. Kobayashi, K. Okumura, and Z. Ovary. 1989. Protective immunity and eosinophilia in IgE-deficient SJ A/9 mice infected with Nippostrongylus brasiliensis and Trichinella spiralis. Proc. Natl. Acad. Sci. USA. 85:4460-4462.
39. Sadick, M., F. Heinzel, B. Holaday, R. Pu, R. Dawkins, and R. Locksley. 1990. Cure of murine Leishmaniasis with an anti-IL-4 monoclonal antibody. J. Exp Med. 171:115-123.
40. Amiri, P., M. Haak-Frendscho, K. Robbins, J. McKerrow, T. Stewart, and P. Jardieu. 1994. Anti-immunoglobulin E treatment decreases worm burden and egg production in Schistisoma mansoni infected normal and IFN-g knockout mice. J. Exp Med. 180:43-51.
41. Fisherman, E. 1960. Does the allergic diathesis influence malignancy. Allergy. 31:74-78.
42. Allegra, J., A. Lipton, H. Harvey, J. Luderer, D. Brenner, R. Mortel, L. Semers, M. Gillin, D. White, and J. Trautlein. 1976. Decreased prevalence of immediate hypersensitivity (atopy) in a cancer population. Cancer Res. 36: 3225-3226.
43. McKee, W., C.A. Arnold, and M. Perlman. 1967. A double blind study of the comparative incidence of malignancy and allergy. J. Allergy Clin. Immunol. 39:294-301.
44. Shapiro, S., O. Heinonen, and V. Siskind. 1971. Cancer and allergy. Cancer. 28:396.