Induction of remission across predefined subgroups
In the RAVE Trial, a statistically non-inferior proportion of patients treated with Rituxan (63.6%) achieved complete remission at 6 months vs cyclophosphamide (CYC) (53.1%)1
Remission:
no disease activity.
Complete Remission:
no disease activity and successful tapering off of prednisone by Month 6.1
- At 6-month, multicenter, randomized, double-blind, double-dummy, noninferiority trial of rituximab as compared with cyclophosphamide for remission induction. Patients with GPA or MPA were included in this exploratory analysis of predefined patient subgroups.
Infection rates from RAVE Trial
In a clinical trial, 62% (61/99) of patients in the Rituxan group experienced an infection of any type compared to 47% (46/98) patients in the cyclophosphamide group by Month 6. The most common infections in the Rituxan group were upper respiratory tract infections, urinary tract infections, and herpes zoster. The incidence of serious infections was 11% in the Rituxan-treated patients and 10% in the cyclophosphamide-treated patients, with rates of approximately 25 and 28 per 100 patient-years, respectively. The most common serious infection was pneumonia.
WARNINGS AND PRECAUTIONS
Progressive Multifocal Leukoencephalopathy (PML)
JC virus infection resulting in PML and death can occur in Rituxan-treated patients with hematologic malignancies or with autoimmune diseases. The majority of patients with hematologic malignancies diagnosed with PML received Rituxan in combination with chemotherapy or as part of a hematopoietic stem cell transplant. The patients with autoimmune diseases had prior or concurrent immunosuppressive therapy. Most cases of PML were diagnosed within 12 months of their last infusion of Rituxan.
Remission rates regardless of prednisone use
Remission:
no disease activity.
Complete Remission:
no disease activity and successful tapering off of prednisone by Month 6.1
The median cumulative prednisone dose through Month 6 was similar across treatment arms (3310 mg for Rituxan vs 3450 mg for cyclophosphamide, P=.055).
Reference
- 1.
- Data on file, Genentech USA/Biogen Idec.
INDICATION
Rituxan (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA).
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:
- infusion reactions
- tumor lysis syndrome (TLS)
- severe mucocutaneous reactions
- progressive multifocal leukoencephalopathy (PML)
Warnings and Precautions
Rituxan administration can also result in additional serious, including fatal, adverse reactions including:
- hepatitis B reactivation
- other infections including bacterial, fungal, new or reactivated viral infections
- cardiovascular events
Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with Rituxan.
Observe patients closely for signs of infection if immunosuppressants other than corticosteroids are used concomitantly.
Common adverse reactions include infections, nausea, diarrhea, headache, muscle spasms, anemia and peripheral edema.