Developmental immunotoxicology assessment of rituximab in cynomolgus monkeys

Toxicological Sciences

Volumn 119, Issue 1, 2011, Pages 116-125

  Vaidyanathan, Anu ^a   McKeever, Kathleen ^a,c   Anand, Banmeet ^a   Eppler, Steve ^a   Weinbauer, Gerhard F ^b   Beyer, Joseph C ^a  

^a GENENTECH INC   (United States)

^b Department of Veterinary Services and Colony Management   (Germany)

^c MEDIMMUNE   (United States)

Author keywords

Anti CD20; Cynomolgus monkey; Developmental immunotoxicology; Embryo fetal development; Pre and postnatal development

Indexed keywords

RITUXIMAB;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANTIBODY RESPONSE; ARTICLE; B LYMPHOCYTE; BIRTH; CLINICAL STUDY; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG MEGADOSE; EMBRYO DEVELOPMENT; FEMALE; FETUS; FETUS DEVELOPMENT; FIRST TRIMESTER PREGNANCY; FOLLOW UP; GESTATIONAL AGE; HAPLORHINI; LOW DRUG DOSE; LYMPHOCYTE DEPLETION; MALE; NONHUMAN; ORGANOGENESIS; PLACENTAL TRANSFER; POSTNATAL DEVELOPMENT; PRENATAL DRUG EXPOSURE; PUERPERIUM; RHEUMATOID ARTHRITIS; VACCINATION;

MACACA FASCICULARIS;

EID: 78650551562     PISSN: 10966080     EISSN: 10960929     Source Type: Journal    
DOI: 10.1093/toxsci/kfq316     Document Type: Article

References (30)

1. Bartlett, M. S. (1937). Some examples of statistical methods of research in agriculture and applied biology. J. R. Stat. Soc. (Suppl. 4), 137-170.
2. Bingham, C. C., Looney, R. J., Deodhar, A., Halsey, N., Greenwald, M., Codding, C., Trzaskoma, B., Martin, F., Agarwal, S., and Kelman, A. (2009). Immunization responses in rheumatoid arthritis patients treated with rituximab: results from a controlled clinical trial. Arthritis Rheum. 62, 64-74.
3. Buse, E. (2005). Development of the immune system in the cynomolgus monkey: the appropriate model in human targeted toxicology. J. Immunotoxicol. 2, 211-216.
4. Coe, C. L., Kemnitz, J. W., and Schneider, M. L. (1993). Vulnerability of placental antibody transfer and fetal complement synthesis to disturbance of the pregnant monkey. J. Med. Primatol. 22, 294-300.
5. Decker, M., Rothermundt, C., Holländer, G., Tichelli, A., and Rochlitz, C. (2006). Rituximab plus CHOP for treatment of diffuse large B-cell lymphoma during second trimester of pregnancy. Lancet Oncol. 7, 693-694.
6. Dunnett, C. W. (1964). New tables for multiple comparisons with a control. Biometrics 20, 482-491.
7. Einfeld, D. A., Brown, J. P., Valentine, M. A., Clark, E. A., and Ledbetter, J. A. (1988). Molecular cloning of the human B cell CD20 receptor predicts a hydrophobic protein with multiple transmembrane domains. EMBO J. 7, 711-717.
8. Frankel, A. E. (2004). Reducing the immune response to immunotoxin, commentary re Hassan et al., pretreatment with rituximab does not inhibit the human immune response against the immunogenic protein LMB-1. Clin. Cancer Res. 10, 13-15.
9. Friedrichs, B., Tiemann, M., Salwender, H., Verpoort, K., Wenger, M. K., and Schmitz, N. (2006). The effect of rituximab during pregnancy on a neonate. Haematologica 91, 1426-1427.
10. Fujimoto, K., Terao, K., Cho, F., and Honjo, S. (1983). The placental transfer of IgG in the cynomolgus monkey. Jpn. J. Med. Sci. Biol. 36, 171-176.
11. Grote-Wessels, S., Frings, W., Smith, C. A., and Weinbauer, G. F. (2010). Immunotoxicology testing in nonhuman primates. In Immunotoxicity Testing: Methods and Protocols, Methods in Molecular Biology (R. R. Dietert, Ed.), Vol 598, Chapter 23, pp. 341-360. Humana Press, New York.
12. Hassan, R., Wiliams-Gould, J., Watson, T., Pai-Scherf, L., and Pastan, I. (2004). Pretreatment with rituximab does not inhibit the human immune response against the immunogenic protein LMB-1. Clin. Cancer Res. 10, 16-18.
13. Hayward, A. R. (1983). The human fetus and newborn: development of the immune response. Birth Defects 19, 289-294.
14. Herold, M., Schnohr, S., and Bittrich, H. (2001). Efficacy and safety of a combined rituximab chemotherapy during pregnancy. J. Clin. Oncol. 19, 389-397.
15. Kimby, E., Sverrisdottir, K. E., and Elinder, G. (2004). Safety of rituximab therapy during the first trimester of pregnancy: a case history. Eur. J. Haematol. 72, 292-295.
16. Klink, D. T., van Elburg, R. M., Schreurs, M. W. J., and van Well, G. T. J. (2008). Rituximab administration in third trimester of pregnancy suppresses neonatal B-cell development. Clin. Dev. Immunol. 2008:271363.
17. Kolk, L., Baars, J. W., Prins, M. H., and Oers, M. H. (2002). Rituximab treatment results in impaired secondary humoral immune responsiveness. Blood 100, 2257-2259.
18. Kruskal, W. H., and Wallis, W. A. (1952). Use of ranks in one-criterion variance analysis. J. Am. Stat. Assoc. 47, 583-621.
19. Malek, A., Sager, R., Kuhn, P., Nicolaides, K. H., and Schneider, H. (1996). Evolution of materno-fetal transport of immunoglobulins during human pregnancy. Am. J. Reprod. Immunol. 36, 248-255.
20. Maloney, D. G., Grillo-Lopez, A. J., White, C. A., Bodkin, D., Schilder, R. J., Neidhart, J. A., Janakiraman, N., Foon, K. A., Liles, T. M., Dallaire, B. K., et al. (1997). IDEC-C2B8 (rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low grade non-Hodgkin's lymphoma. Blood 90, 2188-2195.
21. Nadler, L. M., Ritz, J., Hardy, R., Pesando, J. M., Schlossman, S. F., and Stashenko, P. (1981). A unique cell surface antigen identifying lymphoid malignancies of B cell origin. J. Clin. Invest. 67, 134.
22. Oren, S., Mandelboim, M., Braun-Moscovici, Y., Paran, D., Ablin, J., Litinsky, I., Comaneshter, D., Levartovsky, D., Mendelson, E., Azar, R., et al. (2008). Vaccination against influenza in patients with rheumatoid arthritis: the effect of rituximab on the humoral response. Ann. Rheum. Dis. 67, 937-941.
23. Pentsuk, N., and Van der Laan, J. W. (2009). An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res. Part B 86, 328-344.
24. Reff, M. E., Carner, K., Chambers, K. S., Chinn, P. C., Leonard, J. E., Raab, R., Newman, R. A., Hanna, N., and Anderson, D. R. (1994). Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20. Blood 83, 435.
25. Siegel, S. (1956). In Nonparametric Statistics for the Behavioral Sciences. McGraw-Hill, New York, NY.
26. Stahn, R., Fabricius, H.-A., and Hartleitner, W. (1978). Suppression of human T-cell colony formation during pregnancy. Nature 276, 831-832.
27. Treon, S. P., Shima, Y., and Raje, N. (2000). Interferon-g induces CD20 expression on multiple myeloma cells via induction of Pu.1 and augments rituximab binding to myeloma cells. Blood 94(Suppl. 1), 119a.
28. Vallerskig, T., Gunnarsson, I., Widhe, M., Risselada, A., Klareskog, L., Vollenhoven, R. V., Malmstrom, V., and Trollmo, C. (2006). Treatment with rituximab affects both the cellular and the humoral arm of the immune system in patients with SLE. Clin. Immunol. 122, 62-74.
29. Vugmeyster, Y., Beyer, J., Howell, K., Combs, D., Fielder, P., Yang, J., Qureshi, F., Sandlund, B., Kawaguchi, L., Dummer, W., et al. (2005). Depletion of B cells by a humanized anti-CD20 antibody PRO70769 in macaca fasciularis. Immunotherapy 28, 212-219.
30. Vugmeyster, Y., Howell, K., McKeever, K., Combs, D., and Canova-Davis, E. (2003). Differential in vivo effects of rituximab on two B-cell subsets in cynomolgus monkeys. Int. Immunopharmacol. 3, 1477-1481.