Results With Rituxan

Rituxan® (rituximab), in combination with glucocorticoids, is the first FDA-approved medicine for people with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA). Talk with your doctor to see if Rituxan may be right for you. 

Rituxan, in combination with glucocorticoids, may help put GPA and MPA into complete remission

In a clinical study, 197 adults with GPA or MPA were given either:

  • An IV infusion of Rituxan once a week for 4 weeks plus short-term steroids (called glucocorticoids) for up to 6 months OR
  • A combination of two medicines (cyclophosphamide followed by azathioprine) taken by mouth, every day, for 18 months

The goal of the trial was to see if Rituxan in combination with glucocorticoids worked as well as cyclophosphamide in bringing on complete remission at 6 months in adults with GPA and MPA. "Complete remission" was defined as no disease activity and the ability to stop taking steroids.

Percentage of patients in complete remission after 6 months

Rituxan + GCC was shown to work as well as CYC + AZA

The RAVE Trial showed that Rituxan worked as well as cyclophosphamide to achieve complete remission at 6 months. Also in the study, there was no significant difference in the rates of complete remission at 6, 12, or 18 months for patients treated with Rituxan compared with patients who received the other medicines (38% for the Rituxan group and 31% for the other group). The study also showed that there were no major differences between the overall side effects experienced by each group.

The Rituximab in ANCA-Associated Vasculitis (RAVE) Trial was conducted by the National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network with support from Genentech and Biogen.

Rituxan, in combination with glucocorticoids, may help keep GPA and MPA under control

In a different clinical study, 115 adults with GPA or MPA received treatments to achieve disease control. After that, they were given either:

  • A version of rituximab* approved in the European Union plus short-term steroids OR
  • A medicine called azathioprine plus short-term steroids

The goal of the study was to compare how well each treatment prevented major relapses from occurring. A major relapse was defined as any disease activity that could lead to organ failure or that could be life-threatening. The patients were studied for 28 months.

Percentage of patients who had a major relapse during the study

That means 95% of the patients taking Rituxan did not have a major relapse for 28 months compared with 71% of the patients taking azathioprine.

The MAINRITSAN trial was completed to see if rituximab plus glucocorticoids was better at preventing major relapses among adults with GPA and MPA than azathioprine plus glucocorticoids (GCC for short).

The Maintenance of Remission using EU-approved rituximab in Systemic ANCA-associated Vasculitis (MAINRITSAN) trial was conducted in France and was funded by the French Ministry of Health.

*Rituximab is the generic name for Rituxan.
People who were treated with Rituxan (rituximab) were given a version of rituximab approved in the European Union plus glucocorticoids.

What is the most important information I should know about Rituxan?

Rituxan can cause serious side effects that can lead to death, including:

  • Infusion-Related Reactions: Infusion-related reactions are the most common side effect of Rituxan treatment. Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion 
  • Severe Skin and Mouth Reactions: Tell your healthcare provider if you get any of these symptoms during treatment with Rituxan: painful sores or ulcers on your skin, lips, or in your mouth; blisters; peeling skin; rash; or pustules 
  • Hepatitis B Virus (HBV) Reactivation: If you have had hepatitis B or are a carrier of hepatitis B virus, receiving Rituxan could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems, including liver failure and death. You should not receive Rituxan if you have active hepatitis B liver disease 
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, serious brain infection caused by a virus that can happen in people who receive Rituxan. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML

Please see below and the Rituxan Prescribing Information and Medication Guide for additional Important Side Effect Information, including Most Serious Side Effects.