The RITUXAN for RA EXPERIENCE Program

 

through Genentech
Rheumatology
Access Solutions

$4,000 per
12-month period
toward the cost of
Rituxan for eligible patients

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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 administration can result in serious, including fatal, adverse reactions. These include: infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML).

Warnings and Precautions

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

  • hepatitis B reactivation
  • other infections including bacterial, fungal, new or reactivated viral infections
  • cardiovascular events

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.

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Rituxan has an established safety profile

In the pivotal trials, serious infections occurred in 2% of patients taking Rituxan vs 1% of patients taking placebo

  • Infections of any type were experienced by 39% of patients taking Rituxan vs 34% of patients taking placebo1
Rate of serious infection events  
  • In 938 patients from pooled pivotal trials, incidence of Rituxan adverse events ≥ 2% at least 1% greater than placebo

Pivotal trial infusion information

  • 27% of patients experienced acute infusion reactions with their first infusion, compared with 19% of the placebo group - by the second infusion, 9% of patients experienced infusion related reactions compared with 11% of patients receiving placebo

Serious infections over time

  • Through multiple courses in an analysis of controlled RA clinical trials and open-label extensions, the rate of serious infections remains consistent over time. Rituxan is not recommended for treatment of patients with severe active infections.

SAFETY INFORMATION: Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and up to one year following the completion of Rituxan-based therapy
 
References
1.
Rituxan [package insert]. South San Francisco, CA: Biogen Idec Inc. and Genentech USA, Inc.; February 2010.
2.
Data on file, Genentech USA/Biogen Idec.
3.
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.
4.
Mease PJ, Cohen S, Gaylis NB, et al. Efficacy and safety of retreatment in patients with rheumatoid arthritis with previous inadequate response to tumor necrosis factor inhibitors: results from the SUNRISE trial. J Rheumatol. March 1, 2010; doi:10:3899/jrheum.090442.
5.
Keystone E, Fleischmann RM, Emery P, et al. Multiple courses of rituximab produce sustained efficacy in patients with rheumatoid arthritis with an inadequate response to one or more TNF inhibitor(s). Presented at: The American College of Rheumatology Annual Scientific Meeting; October 16-21, 2009; Philadelphia, PA.
6.
Finckh A, Ciurea A, Brulhart L, et al; on the behalf of the doctors of the Swiss Clinical Quality Management Programme for Rheumatoid Arthritis. Which subgroup of patients with rheumatoid arthritis benefits from switching to rituximab versus alternative anti-tumour necrosis factor (TNF) agents after previous failure of an anti-TNF agent? Ann Rheum Dis. 2010;69(2):387-393. Doi:10.1136/ard.2008.105064.
7.
van Vollenhoven RF, Emery P, Bingham CO III, et al. Long-term safety of rituximab: 6-year follow-up of the rheumatoid arthritis (RA) clinical trials and re-treatment population. Poster presented at: The American College of Rheumatology Annual Scientific Meeting; October 24-29, 2008; San Francisco, CA.
8.
van Vollenhoven RF, Emery P, Bingham CO, et al. Long-term safety of rituximab: follow-up of the RA clinical trials and retreatment population. Presented at European League Against Rheumatism Conference; June 16-19, 2010; Rome, Italy.
9.
Dixon WG, Watson K, Lunt M, British Society for Rheumatology Biologics Register Control Centre Consortium, Silman AJ, Symmons DPM; on behalf of the British Society for Rheumatology Biologics Register. Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti–tumor necrosis factor therapy: Results from the British Society for Rheumatology Biologics Register. Arthritis Rheum. 2006;54(8):2368-2376. doi:10.1002/ art.21978.
10.
Listing J, Strangfeld A, Kary S, et al. Infections in patients with rheumatoid arthritis treated with biologic agents.
Arthritis Rheum. 2005;52(11):3403-3412. doi:10.1002/art.21386.