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Indication

Rituxan® (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.

Rituxan is not recommended for treatment of patients with severe active infections.

Important Safety Information

  • Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML)
  • Hepatitis B reactivation, cardiac arrhythmias, and angina have also been observed
  • Patients should be closely observed for signs of infection if biologic agents and/or DMARDs other than methotrexate are used concomitantly
  • Common adverse reactions include infusion reactions and infections

Please see full prescribing information, including Boxed Warnings for additional safety information.

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How Rituxan works

 
MOA
  • Rituxan is a unique therapy that selectively targets CD20+ B cells, which are believed to play an active role in RA.
  • CD20 is not found on stem cells, pro-B cells, normal plasma cells, or other normal tissues.1
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The role of B cells in RA

B cells are believed to contribute to the immune processes that lead to inflammation and joint damage in 3 critical ways.

Rituxan proposed mechanism of action (MOA)

Rituxan selectively targets CD20+ B cells

Next Section: Clinical Trial Overview

see also

Safety profile: Rituxan has more than 7 years of documented clinical trial experience in RA and more than 100,000 RA patients exposed worldwide.2 Learn more

References
1.
Rituxan [package insert]. South San Francisco, CA: Biogen Idec, Inc. and Genentech USA, Inc.; October 2009.
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Lund FE, Garvy BA, Randall TD, Harris DP. Regulatory roles for cytokine-producing B cells in infection and autoimmune disease. Curr Dir Autoimmun. 2005;8:25-54.
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McInnes IB, Schett G. Cytokines in the pathogenesis of rheumatoid arthritis. Nat Rev Immunol. 2007;7(6):429-442.
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Duddy ME, Alter A, Bar-Or A. Distinct profiles of human B cell effector cytokines: a role in immune regulation? J Immunol. 2004;172(6):3422- 3427.
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Lam J, Takeshita S, Barker JE, Osami K, Ross FP, Teitelbaum SL. TNF-a induces osteoclastogenesis by direct stimulation of macrophages exposed to permissive levels of RANK ligand. J Clin Invest. 2000;106(12):1481-1488.
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Wei S, Kitaura H, Zhou P, Ross FP, Teitelbaum SL. IL-1 mediates TNF-induced osteoclastogenesis. J Clin Invest. 2005;115(2):282-290. doi:10.1172/JCI200523394.
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Palmqvist P, Persson E, Conaway HH, Lerner UH. IL-6, leukemia inhibitory factor, and oncostatin M stimulate bone resorption and regulate the expression of receptor activator of NF-κB ligand, osteoprotegerin, and receptor activator of NF-κB in mouse calvariae. J Immunol. 2002;169(6):3353-3362.
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O’Neill SK, Shlomchik MJ, Glant TT, Cao Y, Doodles PD, Finnegan A. Antigen-specific B cells are required as APCs and autoantibody-producing cells for induction of severe autoimmune arthritis. J Immunol. 2005;174(6):3781-3788.
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Takemura S, Klimiuk PA, Braun A, Goronzy JJ, Weyland CM. T cell activation in rheumatoid synovium is B cell dependent. J Immunol. 2001;167(8):4710-4718.
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Roosnek E, Lanzavecchia A. Efficient and selective presentation of antigen-antibody complexes by rheumatoid factor B cells. J Exp Med. 1991;173(2):487-489.
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Abrahams VM, Cambridge G, Lydyard PM, Edwards JCW. Induction of tumor necrosis factor alpha production by adhered human monocytes: a key role for Fcγ receptor type IIIa in rheumatoid arthritis. Arthritis Rheum. 2000;43(3):608-616.
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Sutton B, Corper A, Bonagura V, Taussig M. The structure and origin of rheumatoid factors. Immunol Today. 2000;21(4):177-183.
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Silverman GJ, Carson DA. Roles of B cells in rheumatoid arthritis. Arthritis Res Ther. 2003;5(suppl 4):S1-S6. doi:10.1186/ar1010.