MABTHERA (rituximab)

Key points

Favourable opinion for reimbursement in the maintenance treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).

What therapeutic improvement?

No therapeutic improvement compared to IMUREL (azathioprine).

Role in the care pathway?

In the first-line treatment for induction of remission of systemic GPA and MPA, rituximab may be prescribed in the same way as cyclophosphamide. Following the achievement of remission, relapses, which occur in more than half of GPA patients and around 30% of MPA patients at 5 years, require the initiation of maintenance treatment with azathioprine (IMUREL) or methotrexate (used off-label) or even mycophenolate mofetil (used off-label) for a period of 12 to 24 months, with the aim of consolidating remission and limiting the risk of relapse.

Role of MABTHERA (rituximab) in the care pathway:

In treatment for the maintenance of remission of systemic GPA and MPA, MABTHERA (rituximab) is a first-line maintenance treatment option for systemic vasculitis. No relevant data are available enabling its role in the care pathway to be ranked compared to the alternatives currently available.

Experience with the use of rituximab in the MAINRITSAN study is limited to 18 months of treatment, which corresponds to 5 rituximab infusion cycles. However, the SPC for MABTHERA recommends a treatment duration of at least 24 months and schedules the possibility of treating patients at high risk of relapse for up to 5 years. Uncertainties remain concerning the optimal administration regimen for MABTHERA (rituximab) as maintenance treatment and its long-term safety associated with its use in this context.

Special recommendations

Monitoring of the safety of rituximab is essential in the context of its long-term prescription.