FAQs
What role do B cells play in RA?
What is the safety & tolerability profile of RITUXAN for RA?
Which of my RA patients are appropriate for RITUXAN?
How can I find information on RITUXAN for RA regarding access, coverage, and reimbursement?
How can I locate an infusion center for my RA patients who have been prescribed RITUXAN?
Where can I have any other questions about RITUXAN answered?
Q & A
- What is RITUXAN?
- The RITUXAN (Rituximab) antibody is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The antibody is an IgG1 kappa immunoglobulin containing murine light- and heavy-chain variable region sequences and human constant region sequences. Rituximab is composed of two heavy chains of 451 amino acids and two light chains of 213 amino acids (based on cDNA analysis) and has an approximate molecular weight of 145 kD. Rituximab has a binding affinity for the CD20 antigen of approximately 8.0 nM.
Reference: RITUXAN (Rituximab) full prescribing information, Genentech, Inc., Feb 28, 2006. - back to FAQ list
- How does RITUXAN Work?
- Mechanism of Action: The Fab domain of Rituximab binds to the CD20 antigen on B lymphocytes, and the Fc domain recruits immune effector functions to mediate B-cell lysis in vitro. Possible mechanisms of cell lysis include complement‑dependent cytotoxicity (CDC) and antibody‑dependent cell mediated cytotoxicity (ADCC). The antibody has been shown to induce apoptosis in the DHL‑4 human B-cell lymphoma line.1
Reference:1. RITUXAN (Rituximab) full prescribing information, Genentech, Inc., Feb 28, 2006. - back to FAQ list
- What role do B cells play in RA?
- B-cells are believed to play a role in the pathogenesis of rheumatoid arthritis (RA) and associated chronic synovitis. In this setting, B-cells may be acting at multiple sites in the autoimmune/inflammatory process, including through production of rheumatoid factor (RF) and other autoantibodies, antigen presentation, T-cell activation, and/or pro-inflammatory cytokine production.
Reference: RITUXAN (Rituximab) full prescribing information, Genentech, Inc., Feb 28, 2006. - back to FAQ list
- What is the safety & tolerability profile of RITUXAN for RA?
- RITUXAN has an established safety & tolerability profile in RA.
- The most common adverse events* with greater incidence in the group receiving RITUXAN (n=540) vs the placebo group (n=398) were hypertension (8% vs 5%), nausea (8% vs 5%), upper respiratory tract infection (7% vs 6%), arthralgia (6% vs 4%), pyrexia (5% vs 2%), and pruritus (5% vs 1%)
- Based on 938 patients in phase II and III studies of RITUXAN (2 x 1000 mg) or placebo administered in combination with methotrexate (MTX)
- Infections of any type were experienced by 39% of patients on RITUXAN vs 34% of patients on placebo in RA clinical studies; the most common infections were nasopharyngitis, upper respiratory tract infections, bronchitis, and sinusitis6
- Serious infections occurred in 2% of patients on RITUXAN vs 1% of patients on placebo6
- Of the acute infusion reactions that occurred with RITUXAN, most were associated with the first infusion (RITUXAN vs placebo: 27% vs 19%, first infusion; 9% vs 11%, second infusion)6
- Less than 1% of acute infusion reactions in either treatment group were considered serious6
*Coded using MedDRA
- The most common adverse events* with greater incidence in the group receiving RITUXAN (n=540) vs the placebo group (n=398) were hypertension (8% vs 5%), nausea (8% vs 5%), upper respiratory tract infection (7% vs 6%), arthralgia (6% vs 4%), pyrexia (5% vs 2%), and pruritus (5% vs 1%)
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Please also see the Safety Profile section for more detailed information.
Reference: RITUXAN (Rituximab) full prescribing information, Genentech, Inc., Feb 28, 2006.
- Which of my RA patients are appropriate for RITUXAN?
- Rituxan (Rituximab) in combination with methotrexate is indicated to reduce signs and symptoms and to slow the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.1
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Inadequate response may manifest as persistent swollen and/or tender joints, persistent pain, prolonged stiffness, significant fatigue, or reduced function despite ongoing or past TNF inhibitor therapy.
- In the RITUXAN for RA pivotal study1,2
- Patients evaluated had a mean disease duration of 12 years
- Patients had >8 swollen joints (66 joint count) and >8 tender joints (68 joint count)
- Patients had to be on anti-TNF therapy for 3 months or longer in order to qualify to enter the study as inadequate responders for efficacy
- Patients who had discontinued an anti-TNF therapy due to safety or tolerability issues were also eligible for the study
Reference:1. RITUXAN (Rituximab) full prescribing information, Genentech, Inc., Feb 28, 2006. 2. Data on file. Genentech/Biogen Idec.
- In the RITUXAN for RA pivotal study1,2
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- How can I find information on RITUXAN for RA regarding access, coverage, and reimbursement?
- For answers to these and many more practice-management-related questions, please contact Genentech Access Solutions™
- By phone @ 1-877-4RITUXAN (1-877-474-8892), then press 2, Monday through Friday 6AM to 5PM PST (you may record a message at any time of day)
- Or online at www.GenentechAccessSolutions.com
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- How can I locate an infusion center for my RA patients who have been prescribed RITUXAN?
- To locate an infusion therapy site for your RA patients who will be receiving RITUXAN, please contact Genentech Access Solutions
- By phone @ 1-877-4RITUXAN (1-877-474-8892), then press 2, Monday through Friday 6AM to 5PM PST (you may record a message at any time of day)
- Or online at www.GenentechAccessSolutions.com
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- Where can I have any other questions about RITUXAN answered?
- For inquiries about RITUXAN call the RISE support line toll-free at 1-877-474-8892, or for information of our other marketed products please visit the Genentech website.
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