Rituxan demonstrated efficacy in the overall population and across studied disease types
Remission:
no disease activity.
Complete Remission:
no disease activity and successful tapering off of prednisone by Month 6.1
A 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 the study. Disease activity was measured on the basis of the BVAS/GPA and flare history, and the physician's global assessment. The specified noninferiority margin was -20 percentage points for the difference in remission rates. Primary analysis was performed by the intent-to-treat method.
INFECTION WARNING
Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of Rituxan-based therapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure). Pneumocystis jiroveci pneumonia (PCP) prophylaxis is also recommended for patients with GPA and MPA during treatment and for at least 6 months following the last Rituxan infusion.
Patient type, renal function, BVAS/GPA, and age did not affect efficacy in the RAVE Trial
- Rituxan met the non-inferiority criteria in patients with and without alveolar hemorrhage and with or without a major renal item on the BVAS/GPA scale2
Remission:
no disease activity.
Complete Remission:
no disease activity and successful tapering off of prednisone by Month 6.1
- CYC=cyclophosphamide; AZA=azathioprine.
- *
- A major renal item includes urinary red-cell casts, biopsy-confirmed glomerulonephritis, or an increase in the baseline serum creatinine concentration of more than 30%. Results shown used worst case carried forward imputation. Two-sided χ2 test. 51 patients in the rituximab group (52%) had at least one major renal item at baseline, as compared with 51 in the control group (52%). 27 patients in the rituximab group (27%) had alveolar hemorrhage at baseline, as compared with 23 in the control group (24%).
References
- 1.
- Stone JH, Merkel PA, Spiera R, et al; for the RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010;363(3):221-232.
- 2.
- 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.