In others, CMC appears to play a limited role and ADCC is most important (46). Infections Safety of biological therapies following rituximab treatment in rheumatoid arthritis patients. A) Mechanisms of action related to direct rituximab-induced signaling. Schematic illustration of the mechanism of action of rituximab. Jazirehi AR, Gan XH, De Vos S, Emmanouilides C, Bonavida B. Rituximab (anti-CD20) selectively modifies Bcl-xL and apoptosis protease activating factor-1 (Apaf-1) expression and sensitizes human non-Hodgkin's lymphoma B cell lines to paclitaxel-induced apoptosis. Rituxan should be discontinued in the event of a serious or life-threatening cardiac event. Czuczman MS, Grillo-Lopez AJ, White CA, et al. The most common infections in the Rituxan group were upper respiratory tract infections, urinary tract infections, and herpes zoster. Depletion of the C3 Component of Complement Enhances the Ability of Rituximab-Coated Target Cells to Activate Human NK Cells and Improves the Efficacy of Monoclonal Antibody Therapy in An in Vivo Model. N Engl J Med. Inhibitory Fc receptors modulate in vivo cytoxicity against tumor targets. Sample processing itself induces signaling changes, making the study of signaling in primary lymphoma samples extremely difficult. 2006;54(9):2793-2806. van Vollenhoven RF, Emery P, Bingham CO III, et al. Generally, rituximab is avoided in the presence of active, significant infections. The dynamics of interaction between such mechanisms are extremely complex given the differences in microenvironment, saturation of receptors and possible exhaustion of proteins or cells vital for effective target cell destruction. Coiffier B, Lepage E, Briere J, et al. The strongest such evidence is the clear demonstration that the combination of rituximab and cytotoxic chemotherapy is effective in a variety of B cell malignancies. Poster OP0332. Rituximab targets a protein called CD20. A positive response to tetanus toxoid vaccine (a T-cell dependent antigen with existing immunity) was similar in patients treated with Rituxan plus MTX compared to patients on MTX alone (39% vs 42%). For example, NK cells are activated and produce IFN when they come in contact with rituximab-coated target cells (57). Arthritis Rheum. However, the ongoing evaluation of mechanisms of action has led to new rituximab-based combinations, novel schedules, and the design of the next generation of antibodies discussed at length elsewhere in this volume. This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking. Complement activation plays a key role in antibody-induced infusion toxicity in monkeys and rats. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIIB randomized, double-blind, placebo-controlled, dose-ranging trial. It is also used in combination with other cancer medicines to treat mature B-cell non-Hodgkin's lymphoma (NHL) and mature B-cell acute leukemia (B-AL). Weng WK, Levy R. Two immunoglobulin G fragment C receptor polymorphisms independently predict response to rituximab in patients with follicular lymphoma. Genentech USA, Inc. Emery P, Fleischmann R, Filipowicz-Sosnowska A, et al. However, FcRIIIA (CD16) and FcJRIIA (CD32) polymorphisms in follicular lymphoma patients treated with rituximab plus CHOP chemotherapy did not predict clinical outcome (23). Taken together, CMC can result in anti-tumor activity in some situations, but this may be offset by shaving of the immune complex from the surface of viable malignant cells, or inhibition of ADCC through C3b blockade of the interaction between rituximab and NK cells. The expression of complement inhibitory molecules (CD55 and CD59) on malignant B cells correlates with the extent of in vitro lysis (24-29). The final sections of this review involves discussion of possible interactions between mechanisms, and how these interactions might impact on the efficacy, or resistance to, rituximab-based therapy. Rheumatology (Oxford). South San Francisco, CA: Biogen and Genentech USA, Inc. Data on file, Label update approval letter, 09/2019. In RA Study 2, where all patients initially received Rituxan, the safety profile of patients who were retreated with Rituxan was similar to those who were retreated with placebo. Keating MJ, O'Brien S, Albitar M, et al. The primary mechanisms by which rituximab likely mediates its anti-tumor activity do not occur independently. Emmanouilides C, Jazirehi AR, Bonavida B. Rituximab-mediated sensitization of B-non-Hodgkin's lymphoma (NHL) to cytotoxicity induced by paclitaxel, gemcitabine, and vinorelbine. In placebo-controlled studies, adverse reactions reported in 5% of patients 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%) of Rituxan-treated vs placebo, respectively. In vitro mechanisms of action of rituximab on primary non-Hodgkin lymphomas. SUMMARY: Rituximab is a monoclonal antibody that was first approved by the FDA as an antineoplastic agent designed to treat B-cell malignancies. and transmitted securely. Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly. Complement depletion, systemically or locally, could result in loss of CMC, or alternatively loss of the inhibitory effect of complement on other mechanisms (66). Npoje s vysokm obsahom antioxidantov, ako s vitamny C a E, preukzatene zlepuj erektiln funkciu tm, e brnia pokodeniu buniek, produkujcich oxid dusnat," hovor Pearlmanov. Genentech USA, Inc. Cohen SB, Keystone E, Genovese MC, et al. 1 CD20 is expressed on nearly 90% of B-cell non-Hodgkin lymphomas, 2 and therefore represents a quasi-universal target on lymphoma cells. Rituxan-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death. The incidence of all grade infections was similar between the arms. Hypogammaglobulinemia: Hypogammaglobulinemia (IgA, IgG, or IgM below the lower limit of normal) has been observed in patients with GPA and MPA treated with Rituxan in GPA/MPA Study 1. Phase I Trial of Toll-Like Receptor 9 Agonist PF-3512676 with and Following Rituximab in Patients with Recurrent Indolent and Aggressive Non Hodgkin's Lymphoma. The earliest such evidence comes from the first studies of radiolabeled anti-CD20 therapy. Thus, complement fixation may actually impede rituximab binding to CD16 and ADCC. National Library of Medicine Screen high-risk patients before the initiation of therapy. Genentech USA, Inc. Data on file, Label update approval letter, 01/2008. Preclinical validation of novel strategies is being followed by clinical evaluation of the most promising approaches. Leonard JP, Link BK, Emmanouilides C, et al. Clinical trials based on these data include evaluation of antibodies with an enhanced ability to signal, mediate CMC and mediate ADCC. All infusion-related reactions were mild to moderate (Grade 1 or 2) except one Grade 3 serious infusion-related reaction (arthralgia) associated with the Month 12 maintenance infusion. For patients treated with Rituxan, physicians should follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course (2 x 1000 mg) of Rituxan.13. Beum PV, Lindorfer MA, Taylor RP. This strong, if indirect, evidence that the interaction between rituximab Fc and CD16 is central to the mechanisms of action of rituximab has led to the development and clinical evaluation of novel strategies for enhancing target cell lysis by NK cells including the addition to rituximab of immunostimulatory agents designed to activate NK cells (54, 55), and development of anti-CD20 antibodies with stronger affinity for CD16 (43, 56). Rituximab has markedly changed the treatment of B-cell malignancies. Taken together, these data suggest different mechanisms are likely important in different scenarios. 2009;68:216-221. Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Infections: Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of Rituxan-based therapy. Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. These processes require that the Fc of the antibody bound to the target cell bind to Fc receptor (FcRs) on the effector cells triggering immune cell activation and death of the target cell (43). CD20 is found on white blood cells called B cells. The overall concept that rituximab will enhance the efficacy of chemotherapy may seem counter-intuitive if one assumes that the mechanism of action of monoclonal antibody therapy is based on activation of immune effector mechanisms. B) Mechanisms of action related to rituximab-induced CMC and ADCC with potential that these two mechanisms can be antagonistic. Concomitant Use with Biologic Agents and DMARDs Other Than MTX: Limited data are available on the safety of the use of biologic agents or DMARDs other than MTX in RA patients exhibiting peripheral B-cell depletion following treatment with Rituxan. The binding of rituximab to cell surface CD20 located on the B lymphocytes results in destruction of the lymphocyte by 3 potential mechanisms, including complement-dependent cytotoxicity, stimulation of apoptosis, or antibody-dependent cytotoxicity (Fig 1.) Infusion-Related Reactions Anti-CD20 monoclonal antibody with enhanced affinity for CD16 activates NK cells at lower concentrations and more effectively than rituximab. Treatment with rituximab at standard weekly dosing is effective in more than 50% of patients with relapsed or refractory CD20-positive follicular non-Hodgkin's lymphoma, but is not curative. Infusion-Related Reactions: In GPA/MPA Study 1, 12% vs 11% (Rituxan-treated vs cyclophosphamide) of patients experienced at least one infusion-related reaction. Rates of serious infection remain stable in patients receiving subsequent courses. It has a unique mode of action and can induce killing of CD20+ cells via multiple mechanisms. Depletion of cellular effectors in these models had no effect on the therapeutic response to rituximab, while depletion of complement through use of Cobra Venom Factor abolished the therapeutic response. Zhou X, Hu W, Qin X. N Engl J Med. The most commonly reported serious infection in the group was mild or moderate bronchitis. Such studies need to be accompanied by rigorous correlative analysis if we are to understand the importance of various mechanisms of action of rituximab and use that information to improve on what is already an indispensable approach to therapy. 2010;37(5):917-927. van Vollenhoven RF, Emery P, Bingham CO III, et al. The antibody labels B lymphocytes, which have the CD20 cell marker. Institute medical management (eg, glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. Rituximab is a prescription drug administered intravenously. van der Kolk LE, Grillo-Lopez AJ, Baars JW, Hack CE, van Oers MH. Data on file, FDA approval letter, 04/2011. Data on file, REFLEX 2-Year Clinical Study Report. Use of antibodies modified to have a reduced ability to fix complement induced fewer infusion reactions. The presence of immune complexes on the surface of cells does not always lead to CMC. The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. makes no representation as to the accuracy of the information contained on sites we do not own or control. government site. official website and that any information you provide is encrypted Haraoui B, Bokarewa M, Kallmeyer I, Bykerk VP; for the RESET Investigators. Inclusion in an NLM database does not imply endorsement of, or agreement with, Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis, as indicated. The half-life is relative to the dose and number of doses administered but ranges between 1.6 and 20 days.9 The medication remains detectable in the serum for 6 months after a single infusion. Resumption of Rituxan treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV. Rituximab is a chimeric monoclonal antibody targeted against CD20 which is a surface antigen present on B cells. Given this complexity, where do we go from here? Kennedy AD, Beum PV, Solga MD, et al. In the rodent model, this reduction in infusion reaction had little effect on anti-tumor activity (34). Last updated on April 26, 2023. Among all exposed patients, adverse reactions reported in greater than 10% of patients include infusion-related reactions, upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis. Arthritis Rheum. Rituximab is a chimeric mouse/human antibody, bearing the human IgG1 and constant regions, and specific to the CD20 antigen expressed on mature B lymphocytes. Reactivation of HBV replication is often followed by hepatitis, ie, increase in transaminase levels. Clearance of apoptotic bodies by complement may impede development of an active immune response (63, 64). Patients were premedicated with antihistamine and acetaminophen before each Rituxan infusion and were on background oral corticosteroids, which may have mitigated or masked an infusion-related reaction; however, there is insufficient evidence to determine whether premedication diminishes the frequency or severity of infusion-related reactions. Mechanisms that are important in one setting may be less important in another, even in the same patient at different times or locations. Czuczman MS, Olejniczak S, Gowda A, et al. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Indeed, IFN is known to upregulate the high affinity Fc, receptor (CD64) on granulocytes (58), and so IFN could enhance their ability to mediate ADCC. Because they lack CD20, stem cells and plasma cells are not selectively targeted by Rituxan. 2014;371(19):1771-1780. HBV reactivation has been reported up to 24 months following completion of Rituxan therapy. Presented at: European League Against Rheumatism Conference; June 12-15, 2013; Madrid, Spain. Therefore, serious fungal, bacterial and new or reactivated viral infections (for example, hepatitis B or C, shingles) can occur during or after treatment. Rubbert-Roth A, Tak PP, Zerbini C, et al. Thus, whether given weekly or monthly, rituximab is present at therapeutic levels in the circulation of patients for months at a time. 2011;70(1):39-46. Rituximab concentration, immune effector cell infiltration, FcR saturation, and complement depletion in the local micro-environment could all impact on whether a given mechanism is active. Identify the most common adverse events associated with rituximab therapy. Embryo-Fetal Toxicity:Based on human data, Rituxan can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero. The most common infections were nasopharyngitis, upper respiratory tract infections, urinary tract infections, bronchitis, and sinusitis. In GPA/MPA Study 4, serious infections were reported in 7 patients (28%), and included influenza (2 patients [8%]) and lower respiratory tract infection (2 patients [8%]) as the most frequently reported events. This suggests selective elimination or trafficking out of the circulation of CLL cells expressing lower amounts of CD59 that might be more sensitive to CMC. Thus far, none of these strategies has been unequivocally successful, but evaluation is ongoing. Long-term safety of rituximab: 6-year follow-up of the rheumatoid arthritis (RA) clinical trials and re-treatment population. There are several specific US boxed warnings on the package insert12: Severe transfusion reactions resulting in anaphylaxis characterized by fever, hypotension, bronchospasm, urticaria, and angiodema. In fact, results of a number of studies point to more than one mechanism playing a role in a single model including an increase in complement inhibitory molecules, decreased expression of CD20, and enhanced expression of anti-apoptotic molecules (59, 60). Genentech Analysis of SHA Claims and Managed Markets Insight & Technology (MMIT) Data. In the experience with Rituxan in 2578 RA patients, the rate of myocardial infarction (MI) was consistent with MI rates in the general RA population. Rituximab infusion promotes rapid complement depletion and acute CD20 loss in chronic lymphocytic leukemia. Federal government websites often end in .gov or .mil. What does Rituxan do to your body? Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following Rituxan therapy. The safety of readministration of Rituxan to patients with severe mucocutaneous reactions has not been determined. Complement-mediated cell death induced by rituximab in B-cell lymphoproliferative disorders is mediated in vitro by a caspase-independent mechanism involving the generation of reactive oxygen species. Reff ME, Carner K, Chambers KS, et al. Medically reviewed by Philip Thornton, DipPharm. Therapeutic activity of humanized anti-CD20 monoclonal antibody and polymorphism in IgG Fc receptor FcgammaRIIIa gene. Renal Toxicity: Severe, including fatal, renal toxicity can occur after Rituxan administration in patients with NonHodgkins Lymphoma (NHL). Perhaps the strongest evidence for the importance of ADCC in animal models comes from the work of Clynes and colleagues who found that antibody was effective in wild type mice, but not in mice lacking the common FcR chain(47). Its clinical significance is unknown. Ann Rheum Dis. Tumor Cell Expression of CD59 Is Associated With Resistance to CD20 Serotherapy in Patients With B-Cell Malignancies. 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