What is the use of Mabthera (Rituximab)?

From the Guidelines

Mabthera, also known as rituximab, is a standard of care for adult Burkitt lymphoma/leukaemia when added to intensive chemotherapy, as it significantly improves 3-year event-free survival and overall survival rates. This is based on the most recent and highest quality study available, which was published in 2024 1. The study found that the addition of rituximab to chemotherapy resulted in a 3-year event-free survival rate of 75% and a 3-year overall survival rate of 83%, compared to 62% and 70%, respectively, without rituximab.

Key Points

• Mabthera is a monoclonal antibody that targets and destroys B cells with the CD20 protein on their surface
• It is used to treat certain autoimmune disorders and types of blood cancers, including non-Hodgkin lymphoma and Burkitt lymphoma/leukaemia
• The standard dosing for Mabthera varies depending on the condition being treated, but it is typically administered as an intravenous infusion
• Common side effects include infusion reactions, increased risk of infections, and potential cardiac issues
• Patients should receive premedication with acetaminophen and an antihistamine before infusions to reduce reaction risk
• Blood counts should be monitored regularly during treatment, and patients should be screened for hepatitis B before starting therapy as the virus can reactivate during treatment, as noted in a 2017 study 1

Important Considerations

• Mabthera should not be administered to pregnant women as it may harm the developing fetus
• Patients with a history of hepatitis B should be closely monitored for reactivation during treatment
• The addition of rituximab to chemotherapy has been shown to improve outcomes in adult Burkitt lymphoma/leukaemia, but it may also increase the risk of toxicity, particularly in older patients 1

From the FDA Drug Label

In exploratory analyses defined by age, there was no observed benefit from the addition of RITUXAN to fludarabine and cyclophosphamide among patients 70 years of age or older in CLL Study 1 or in CLL Study 2; there was also no observed benefit from the addition of RITUXAN to fludarabine and cyclophosphamide among patients 65 years of age or older in CLL Study 2 The drug label does not provide information about Mabthera. However, Mabthera is another name for Rituximab.

• Rituximab is used to treat various conditions, including non-Hodgkin's lymphoma, rheumatoid arthritis, and granulomatosis with polyangiitis.
• The incidence of adverse reactions was higher among older patients, particularly those 70 years or older, who received RITUXAN in combination with fludarabine and cyclophosphamide.
• No overall differences in efficacy were observed between older and younger patients in some studies, but the clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects 2.

From the Research

Mabthera Overview

• Mabthera, also known as Rituximab, is an anti-CD20 monoclonal antibody used in the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukaemia 3, 4, 5.
• It works by inducing lysis and apoptosis of normal and malignant human B cells, and sensitising malignant B cells to the cytotoxic effect of chemotherapy 3.

Efficacy in Non-Hodgkin's Lymphoma

• Rituximab has been shown to be effective in combination with chemotherapy in patients with indolent or aggressive B-cell non-Hodgkin's lymphoma (NHL) 3, 4, 5.
• In patients with relapsed or refractory indolent NHL, rituximab monotherapy has achieved objective response rates of 40-60% 4.
• The combination of rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) has been shown to be cost-effective as first-line therapy for advanced-stage diffuse large B-cell NHL 3.

Efficacy in Chronic Lymphocytic Leukaemia

• Rituximab has been shown to be effective in combination with fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia (CLL) 5.
• The addition of rituximab to fludarabine plus cyclophosphamide significantly prolonged progression-free survival in previously untreated patients with CLL 5.

Safety and Tolerability

• Rituximab is generally well tolerated, with infusion-related reactions being one of the most commonly occurring adverse events 6, 5.
• The majority of patients experience mild to moderate infusion-related reactions during the first administration of rituximab, but the incidence decreases markedly with subsequent infusions 6.
• Rituximab does not add to the toxicity of chemotherapy, with the exception of a higher rate of neutropenia 6.

Other Uses

• Rituximab has also been approved for use in rheumatoid arthritis, particularly in patients who have failed treatment with TNFalpha blockers 7.