Rituxan Clinical Data

REFLEX Trial: End Points

Rituxan was studied in TNFi nonresponders. The primary end point was ACR20 at 6 months.1

In the pivotal placebo-controlled trial, a significantly higher proportion of patients treated with one course of Rituxan achieved an ACR response vs placebo.2

Rituxan vs placebo at 6 months - primary end point for response was ACR20[2] View Full Size
*
p<0.0001
MTX=methotrexate.

The 24-week pivotal REFLEX study (Study 1) 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 x 1000-mg infusions + MTX or placebo + MTX. The primary end point was ACR20.2

Pivotal-trial patient disposition2

  • 60% had been on 1 previous TNFi
  • 40% had 2 or 3 prior TNFi therapies

IMPORTANT SAFETY INFORMATION

Infection Data from REFLEX

  • Infections of any type were experienced by 39% of patients taking Rituxan vs 34% of patients taking placebo
  • Serious infections occurred in 2% of patients taking Rituxan vs 1% of patients taking placebo

Infusion Reaction Data from REFLEX

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

Secondary End point: Mean change in DAS28 scores over 6 months1

TNFi nonresponders through 6 months[1] View Full Size

DAS28 is a secondary end point of the REFLEX Trial.
Adapted from Cohen et al for the REFLEX Trial Group.1

 

65% of patients in the group receiving Rituxan achieved good or moderate EULAR response vs 22% in the placebo group at Week 24 (p<0.0001).1

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
REFERENCES
1.
Rituxan [package insert]. South San Francisco, CA: Biogen Idec Inc., and Genentech USA, Inc.; February 2012.
2.
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.
Clinical Trial Safety Data
REFLEX Trial: Radiographic Data
Efficacy Over Multiple Courses
How Rituxan Works
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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