Rituxan Clinical Data

REFLEX Trial: End Points
Clinical Trial Safety Data
REFLEX Trial: Radiographic Data
Efficacy Over Multiple Courses
How Rituxan Works

3 critical roles B cells may play in RA

B cells are believed to contribute to the immune processes that lead to inflammation and joint damage in RA

B-cell illustration chart View Full Size
ANTIGEN PRESENTATION

Contributes to T-cell cytokine production and activation of other immune cells in the inflammatory cascade.1,2

In circumstances observed in vitro, B cells were able to present antigen up to 10,000-fold more efficiently than other antigen-presenting cells.3

AUTOANTIBODY PRODUCTION

Immune complexes composed of autoantibodies, including anti-CCP and RF, help perpetuate the inflammatory cascade.4-7

CYTOKINE PRODUCTION

B cells are implicated in the production of proinflammatory cytokines such as IL-6, IL-1, and TNF.3,7,8

In some models, IL-6, IL-1, and TNF—as well as other factors—enhance RANKL, which mediates osteoclastogenesis.9-11

IMPORTANT SAFETY INFORMATION

CONCOMITANT USE WITH BIOLOGIC AGENTS AND DMARDS OTHER THAN METHOTREXATE IN RA:
  • Limited data are available on the safety of the use of biologic agents or DMARDs other than methotrexate in patients exhibiting peripheral B-cell depletion following treatment with rituximab
  • Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly

Mechanism of action of Rituxan

CD20 is not found on stem cells, Pro-B cells, normal plasma cells, or other normal tissues.1

MOA illustration View Full Size

Because they lack CD20, stem cells and plasma cells are not selectively targeted by Rituxan.2

 

How Rituxan Works: MOA

Understanding how Rituxan works in Rheumatoid Arthritis.

 

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REFERENCES
1.
O'Neill SK, Shlomchik MJ, Glant TT, Cao Y, Doodes 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.
2.
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.
3.
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.
4.
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.
5.
Abrahams VM, Cambridge G, Lydyard PM, Edwards JCW. Induction of tumor necrosis factor production by adhered human monocytes: a key role for FcY receptor type IIIA in rheumatoid arthritis. Arthritis Rheum. 2000;43(3):608-616.
6.
Sutton B, Corper A, Bonagura V, Taussig M. The structure and origin of rheumatoid factors. Immunol Today. 2000;21(4):177-183.
7.
Silverman GJ, Carson DA. Roles of B cells in rheumatoid arthritis. Arthritis Res Ther. 2003;5(suppl 4):S1-S6. doi:10.1186/ar1010.
8.
McInnes IB, Schett G. Cytokines in the pathogenesis of rheumatoid arthritis. Nat Rev Immunol. 2007;7(6):429-442.
9.
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.
10.
Lam J, Takeshita S, Barker JE, Osami K, Ross FP, Teitelbaum SL. TNF-α induces osteoclastogenesis by direct stimulation of macrophages exposed to permissive levels of RANK ligand. J Clin Invest. 2000;106(12):1481-1488.
11.
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.
12.
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-B ligand, osteoprotegerin, and receptor activator of NF-B in mouse calvariae. J Immunol. 2002;169(6):3353-3362.
13.
Rituxan [package insert]. South San Francisco, CA: Biogen Idec Inc., and Genentech USA, Inc.; February 2012.
14.
Cohen SB, Emery P, Greenwald MW, et al; for the REFLEX Trial Group. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54 (9):2793-2806. doi:10.1002/art.22025.
Important Safety Information
Patient Selection Registry Data

May we also suggest

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

BOXED WARNINGS

Rituxan administration can result in serious, including fatal, adverse reactions. These include:

WARNINGS AND PRECAUTIONS

Rituxan administration can also result in additional serious, including fatal, adverse reactions including:

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.

For additional safety information, please see the full prescribing information, including BOXED WARNINGS and Medication Guide.

Attention Healthcare Provider: Provide Medication Guide to patient prior to Rituxan infusion.

Indication & Safety INFORMATION

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