While the efficacy of Rituxan was supported by two well-controlled trials in RA patients who had inadequate responses to non-biologic DMARDs, but who had not failed TNF antagonist therapy, a favorable risk benefit relationship has not been established in this population (See PRECAUTIONS.)

REFERENCES

1. Valentine MA, Meier KE, Rossie S, et al. Phosphorylation of the CD20 phosphoprotein in resting B lymphocytes. J Biol Chem 1989;264(19): 11282–7. 2^. Einfeld DA, Brown JP, Valentine MA, et al. Molecular cloning of the human B cell CD20 receptor predicts a hydrophobic protein with multiple transmembrane domains. EMBO J 1988;7(3):711–7.

3. Anderson KC, Bates MP, Slaughenhoupt BL, et al. Expression of human B cell-associated antigens on leukemias and lymphomas: A model of human B-cell differentiation. Blood 1984;63(6):1424–33.

4. Tedder TF, Boyd AW, Freedman AS, et al. The B cell surface molecule B1 is functionally linked with B-cell activation and differentiation. J Immunol 1985;135(2):973–9.

5. Tedder TF, Zhou LJ, Bell PD, et al. The CD20 surface molecule of B lymphocytes functions as a calcium channel. J Cell Biochem 1990;14D:195.

6. Press OW, Applebaum F, Ledbetter JA, Martin PJ, Zarling J, Kidd P, et al. Monoclonal antibody 1F5 (anti-CD20) serotherapy of human B-cell lymphomas. Blood 1987;69(2):584–91.

7. Dorner, T, Rumester, G. The role of B-cells in rheumatoid arthritis: mechanisms and therapeutic targets. Curr Op Rheum 2003;15:246-52.

8. Reff ME, Carner C, Chambers KS, Chinn PC, Leonard JE, Raab R, et al. Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20. Blood 1994;83(2):435–45.

9. Demidem A, Lam T, Alas S, Hariharan K, Hanna N, and Bonavida B. Chimericanti-CD20 (IDEC-C2B8) monoclonal antibody sensitizes a B cell lymphoma cell line to cell killing by cytotoxic drugs. Cancer Biotherapy & Radiopharmaceuticals 1997;12(3):177–86.

10. Maloney DG, Liles TM, Czerwinski C, Waldichuk J, Rosenberg J, Grillo-López A, et al. Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma. Blood 1994;84(8):2457–66.

11. Berinstein NL, Grillo-López AJ, White CA, Bence-Bruckler I, Maloney D, Czuczman M, et al. Association of serum Rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lymphoma. Annals of Oncology 1998;9:995–1001.

12. Maloney DG, Grillo-López AJ, Bodkin D, White CA, Liles T-M, Royston I, et al. IDEC-C2B8: Results of a phase I multiple-dose trial in patients with relapsed non-Hodgkin's lymphoma. J Clin Oncol 1997;15(10):3266–74.

13. Maloney DG, Grillo-López AJ, White CA, Bodkin D, Schilder RJ, Neidhart JA, et al. IDEC-C2B8 (Rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood 1997;90(6):2188–95.

14. McLaughlin P, Grillo-López AJ, Link BK, Levy R, Czuczman MS, Williams ME, et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol 1998;16(8):2825–33.

15. Piro LD, White CA, Grillo-López AJ, Janakiraman N, Saven A, Beck TM, et al. Extended Rituximab (anti-CD20 monoclonal antibody) therapy for relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma. Annals of Oncology 1999;10:655–61.

16. Data on file.

17. Davis TA, White CA, Grillo-López AJ, Velasquez WS, Lin B, Maloney DG, et al. Single-agent monoclonal antibody efficacy in bulky Non-Hodgkin's lymphoma: results of a phase II trial of rituximab. JCO 1999;17:1851-7.

18. Davis TA, Grillo-López AJ, White CA, McLaughlin P, Czuczman MS, Link BK, Maloney DG, Weaver RL, Rosenberg J, Levy R. Rituximab anti-CD20 monoclonal antibody therapy in non-hodgkin's lymphoma: safety and efficacy of re-treatment. J Clin Oncol 2000;18(17):3135–43.

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