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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.

Efficacy over multiple courses Print Page

Patients retreated with Rituxan + MTX were more likely to maintain their initial ACR response at Week 48 vs those retreated with MTX alone2

ACR responses following additional courses of Rituxan in open-label extension trials

Within-group, pooled completer analysis: Conducted in a subset of TNFi inadequate responders from Rituxan clinical trials who responded to an initial course of therapy (≥20% improvement in swollen and tender joints). All points include at least 4 courses and 6-month data for each course. Data derived from Keystone et al4 and Data on file from ACR 2009.2

Efficacy that lasts through 6 months with one course

In the pivotal placebo-controlled trial, one course of Rituxan achieved significantly higher ACR responses vs placebo at 6 months in TNFi inadequate responders (ACR 20: 51% for Rituxan vs 18% for placebo; P<.0001).3,a In the same study, patients receiving Rituxan + MTX had a significantly greater decrease in HAQ at Week 24 compared with MTX alone.1

Rituxan protects joints by slowing the progression of structural damage

After 2 years, the majority of Rituxan patients in the REFLEX study experienced no radiographic progression.1

The 24-week pivotal REFLEX study enrolled 520 patients (499 evaluable) with active RA who had an inadequate response to at least 1 TNFi therapy and active disease (≥8 swollen and 8 tender joints). Patients were randomized to receive 2 × 1000-mg infusions + MTX or placebo + MTX. The primary end point was ACR 20.
  • 87% of Rituxan-treated patients who had no progression in the first year also had no progression in the second year1

At 2 years, patients treated with Rituxan demonstrated a further slowing in radiographic progression compared with Year 12

Patients in the placebo + MTX arm could have received retreatment with Rituxan from Week 16 onward.
Adapted from Rituxan full prescribing information.

Next Section: Retreatment Safety

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.
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.
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.