Summary

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• Rituxan (rituximab) is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular, CD20-positive B cell Non-Hodgkin’s Lymphoma (NHL) as a single agent; for the treatment of adult patients with previously untreated follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma (NHL) in combination with first-line chemotherapy and, in adult patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; for the treatment of adult patients with non-progressing (including stable disease), low-grade, CD20-positive, B-cell Non-Hodgkin’s Lymphoma (NHL) as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; for the treatment of adult patients with previously untreated diffuse large B-cell, CD20-positive Non-Hodgkin’s Lymphoma (NHL) in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens; for the treatment of pediatric patients aged 6 months and older with mature B-cell Non-Hodgkin’s Lymphoma (NHL) and mature B-cell acute leukemia (B-AL) - previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy; for the treatment of adult patients with previously untreated and previously treated CD20-positive Chronic Lymphocytic Leukemia (CLL) in combination with fludarabine and cyclophosphamide (FC); for the treatment of rheumatoid arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have an inadequate response to one or more TNF antagonist therapies; for the treatment of granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA) in adult and pediatric patients 2 years of age and older in combination with glucocorticoids; and for the treatment of moderate to severe pemphigus vulgaris (PV) in adult patients.
• This summary is based on the review of 42 systematic review(s)/meta-analysis(es). ^[1-42]
• Follicular Lymphoma (FL): Rituximab maintenance treatment significantly improved progression-free survival (PFS) compared to observation but did not show significant benefits in overall survival (OS) across regimens.
• ANCA-Associated Vasculitis (AAV): Rituximab demonstrated comparable efficacy to cyclophosphamide for remission induction, with superior effectiveness in relapsing disease and lower relapse rates in maintenance therapy compared to azathioprine.
• Rheumatoid Arthritis (RA): Rituximab significantly reduced ACPA titres compared to abatacept and TNFi, but no significant differences were observed among rituximab, abatacept, and tocilizumab in achieving an ACR70 response at six months.
• Pemphigus Vulgaris: Dose de-escalated rituximab protocols yielded high remission rates, though these rates varied significantly, with complete remission ranging from 41.7% to 100%.
• Extended rituximab courses in FL were associated with higher toxicity compared to standard maintenance.
• Rituximab and cyclophosphamide had similar adverse event rates in AAV, with rituximab maintenance reducing relapse rates without introducing new safety concerns. Faster tapering of glucocorticoids led to lower serious infection rates.
• In RA, infection rates, including serious infections, were not significantly different between rituximab and non-rituximab treatments.
• Population types and subgroup considerations include advanced FL patients, patients with active EGPA and unfavorable prognostic factors in AAV, RA patients treated with bDMARDs and tsDMARDs, adult patients with and without CNS/BM involvement in Burkitt Lymphoma, patients treated with dose de-escalated rituximab protocols in Pemphigus Vulgaris, patients treated with low-dose rituximab in ITP, and pediatric and adult patients with resistant or refractory IgA Vasculitis.