Rapid Rituximab Research Articles

Rapid rituximab administration: Safety of 60-minute infusions in malignant and benign haematological disease

Rapid rituximab administration: Safety of 60-minute infusions in malignant and benign haematological disease

EE425 Estimating HCP Labor Time and Cost Saving with the Use of Rapid Rituximab Infusions Versus Standard Rituximab Infusions for the Treatment of Adults with Follicular Lymphoma and Diffuse Large B-Cell Lymphoma in Induction Phase

EE425 Estimating HCP Labor Time and Cost Saving with the Use of Rapid Rituximab Infusions Versus Standard Rituximab Infusions for the Treatment of Adults with Follicular Lymphoma and Diffuse Large B-Cell Lymphoma in Induction Phase

Rapid Rituximab: An Inpatient Pilot Project to Increase Education and Use Among Oncology Nurses

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Assessment Of Hypersensitivity Reactions and Feasibility Of a 60 Minute Rapid Infusion Rituximab Protocol At a Comprehensive Cancer Center

IntroductionRituximab (R) is a chimeric monoclonal antibody with approved indications for non-hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Infusion reactions among patients with NHL are common during the first infusion (incidence of 77%), but decrease with subsequent infusions. Consequently, infusions have been gradually titrated, which may take more than three hours for completion depending on dose and tolerability. However, emerging data suggest that rapid infusion protocols may be safe for patients who receive the first dose with minimal infusion toxicity. MethodsThe purpose of this study was to assess the feasibility of a rapid infusion R protocol in a comprehensive cancer center's outpatient infusion center. The primary outcome measure was the incidence of grade 3 and 4 hypersensitivity reactions during a 60 minute infusion protocol of R in patients with B-cell malignancies. Secondary objective included infusion time savings of a 60 minute infusion of R versus a standard titration schedule, as well as nursing satisfaction. Patients were enrolled in this prospective, single institution, single arm study which was approved by the investigational review board. Inclusion criteria included age >18 years, diagnosis of indolent or intermediate grade B-cell malignancy, second R infusion within 3 months of first infusion, and planned outpatient treatment with a regimen including R therapy at a dose of 375mg/m2. Patients were excluded for diagnosis of an aggressive lymphoma histology, absolute lymphocyte count > 10 x 103/µL, enrollment on another clinical trial, allergy to murine-containing medications, exposure to R (<6 months from first dose) prior to enrollment in this study, or grade 3 or 4 hypersensitivity reaction during first R infusion. All patients received the first dose of R by the standard titration schedule as described in the package insert. The investigational protocol was instituted for the second R administration. The infusion began at 100mg/hr administered over 15 minutes and the remaining dose was given over 45 minutes. All patients received 50mg of oral diphenhydramine and 650mg of oral acetaminophen as premedication. To calculate time savings between rapid infusion and standard titration, each patient served as their own control. Nursing data collection included monitoring vitals every 15 minutes (blood pressure, heart rate, temperature, respiratory rate), start and stop times of R infusion, description and grade of hypersensitivity reactions, administration of rescue medications during infusion, and survey assessment of nursing satisfaction. ResultsFrom October 2010 to April 2013, 52 patients were enrolled to the study. Fifty received rapid infusion over 60 minutes during the second R administration. The 2 patients who did not continue on study were deemed ineligible. Patient 1 expired secondary to disease progression after signing consent and patient 2 experienced a grade 3 reaction following end of first infusion. The median age was 63 years (19-85) with 60% female. Chemotherapy regimens included: R-cyclophosphamide, doxorubicin, vincristine, prednisone (RCHOP, n = 19), single-agent R (n = 14), R-bendamustine (BR, n=7), R-cyclophosphamide, vincristine, prednisone (RCVP, n=4), R-gemcitabine, oxaliplatin (RGEMOX, n=3), R-fludarabine, cyclophosphamide (FCR, n=1), R-pentostatin, cyclophosphamide (PCR, n=1) and R-bortezomib (n=1). The rate of infusion related reactions (all grades) observed with the rapid infusion protocol was 0% (1-sided 97.5% CI 0-7.1%). The mean time for the rapid R infusion was 62.4 (95% CI 61.2-63.6) minutes. When compared to the standard second dose infusion recommendations, a mean time of 94.2 (95% 90-98.4) minutes was saved with rapid infusion. Post infusion nursing surveys demonstrated 100% satisfaction with administration of rapid infusion over standard titration practice. ConclusionsA 60 minute rapid rituximab infusion can be safely administered in an outpatient infusion center. The faster infusion allows for less resource utilization and increased nursing satisfaction. Disclosures:No relevant conflicts of interest to declare.

Rapid rituximab infusion is safe and well tolerated in malignant and benign disease.

Although the safety and feasibility of rapid rituximab administration has been demonstrated for B-cell malignancies, there is scant data in the literature to support its use in patients with benign diseases. To identify the incidence of infusion-related reaction with rapid rituximab administration in malignant and benign disease. Secondary objective was to determine the infusion time saved between standard administration and rapid rituximab administration. A retrospective cohort study was conducted by reviewing electronic medical records from December 2018 to April 2020. Adult patients who received at least one dose of rapid rituximab were included. A total of 63 patents were included. The incidence of an infusion-related reaction with rapid rituximab was 1.6%. The one patient who reacted had a diagnosis of neuromyelitis optica. The mean infusion time saved was 2.9 hours (95% CI: 2.7-3.1; P-value <0.001). The use of the rapid rituximab administration is safe and well tolerated in both benign and malignant disease.

Utilizing a novel four-drug regimen to reduce the incidence of infusion-related reactions for first-dose rituximab infusions: An institutional review of rituximab infusion-related reactions in lymphoma patients.

e19148 Background: Rituximab is a chimeric monoclonal anti-CD20 antibody utilized in the treatment of several disease states including B-cell non-Hodgkins Lymphoma. Infusion-related reactions (IRR) with rituximab occur with an incidence of up to 77% during the first infusion. The occurrence of an infusion reaction adds to the cost and time of rituximab administrations, especially with prolonged chair time and increased nursing and physician support, and decreased quality of life. The University of Arizona Cancer Center (AZCC) initiated a four-drug premedication regimen consisting of dexamethasone, famotidine, diphenhydramine, and acetaminophen. Our study examined the frequency of first-dose rituximab infusion reactions with our premedication regimen as compared to other published regimens. Methods: A retrospective chart review for all first-dose rituximab infusions was conducted for lymphoma patients treated with BR or RCHOP regimens from 11/2013 through 6/2019 at the AZCC. Data points collected included baseline patient demographics as well as rituximab infusion data. Results: In our study, the median age of the patient population was 64 years (range 22-89), 60.5% were males, and the average BSA was 2 m2 (range 1.39-3.04). The average rituximab dose was 750 mg (range 521-1140) and the average infusion time was 301 minutes (range 197-512). IRR with first time Rituximab was seen in 19 patients out of 81 total patients (23.5%). Of these IRR, 52.6% occurred in BR versus 47.4% in RCHOP. The most frequent IRR symptoms seen included flushing, itching, feeling hot, and tingling. The average infusion time for IRR patients was 334 minutes versus 284 minutes in patients not experiencing IRR. Grade 2 reactions were reported in 14 patients (73.7%) with grade 3 IRR’s reported in 5 patients (26.3%). Onset of IRR occurred on average during the first 61.6 minutes of the start of infusion (range 10-108 minutes). Conclusions: A novel four drug premedication regimen consisting of corticosteroids, antihistamines H2RA antatagonist and analgesic, resulted in a much lower rituximab infusion reaction rate (23.5%) than what has been previously reported in literature using standard premedications ( &gt; 50%). The utilization of this four drug combination therapy provides the means to reduce first dose rituximab IRR in patients while maximizing patient care and increasing the number of patients who were able to receive Rapid Rituximab during their next cycle of chemotherapy.

Rapid-Infusion Rituximab in a Pediatric Population.

The use of rapid rituximab infusion in certain pediatric populations has generally been regarded as safe. The safety of our institution's rapid rituximab protocol was evaluated. The primary end point was the number of and severity of adverse drug reactions. Secondary end points included a description of the patient population defined by the indication, dose, and number of rituximab infusions administered. Additionally, the difference in infusion times in hours of those receiving rapid rituximab infusions versus the theoretical infusion time of subsequent administration rate schedules was defined. A total of 88 infusions for 22 patients were reviewed. No dose-limiting adverse reactions were observed. Three patients experienced grade 1 isolated infusion-related adverse events during a single infusion encounter. Two of the three patients received additional doses of rapid rituximab infusions without incident, whereas the other patient no longer required rituximab therapy. The use of a 90-minute rituximab infusion protocol in pediatric patients with non-rheumatic diseases was well tolerated.

Concentration and Glycoform of Rituximab in Plasma of Patients with B Cell Non-Hodgkin's Lymphoma.

Therapeutic antibodies have heterogeneities in their structures, although its structural alteration in the body is unclear. Here, we analyzed the change of amino acid modifications and carbohydrate chains of rituximab after administration to patients. Twenty B cell non-Hodgkin's lymphoma patients who were treated with rituximab for the first time or after more than one year's abstinence were recruited. Structural analysis of rituximab was carried out at 1h after administration and at the trough by using liquid chromatography/time-of-flight-mass spectrometry. Plasma rituximab concentration and pharmacodynamic markers were also determined. Of recruited twenty, 3 patients exhibited rapid rituximab clearance. Nine types of carbohydrate chains were detected in rituximab isolated from the blood. The composition ratios in some glycoforms were significantly different between at 1h after administration and at the trough, although consisted amino acids remained unchanged. The patients with high clearance showed extensive alterations of glycoform composition ratios. However, pharmacodynamics makers were not different. Inter-individual variations in plasma concentrations of rituximab were found in some B-NHL patients. We could analyze a change in glycoforms of rituximab in the patients, and this finding may affect the pharmacokinetics of rituximab.

Assessing the Need for a Biosimilar: A Systematic Literature Review of the Treatment Burden of Rituximab in Hematological Malignancies

BACKGROUND: Advanced targeted therapies have improved survivals and efficacies in patients with certain hematology conditions. However, the treatment costs and safety are some concerns among healthcare providers, patients, and payers.OBJECTIVES: To identify and characterize the treatment burden of rituximab, focusing on drug cost, toxicity, and other treatment-related costs in hematological malignancies, given the anticipated market entry of biosimilar products.[1]METHODS: We conducted a systematic literature review (SLR) using the online version of Index Medicus identified relevant publications using pertinent search terms (see Table) to capture treatment-related cost and non-cost burden publications in English language, publication dates 01/01/2010 to 01/24/2018.RESULTS: Of the 704 publications returned in the search, a total of 28 US and ex-US treatment burden studies (9 cost, 16 non-cost, and 3 drug route comparison studies) were included in the review. US (4) and ex-US (5) treatment cost studies found that direct medical costs of care were dramatically increased with the addition of rituximab or that rituximab represented a large proportion of total costs of care. For publications with calculated benefits associated with treatment, the addition of rituximab to CT was coupled with life-year gains and lower mortality. A large observational study found no difference in all-cause hospitalization rates in the 12 months following rituximab treatment. While studies designed to evaluate rituximab toxicity have found the addition of rituximab to CT to be associated with a general increase in incidence of adverse events (AEs) overall, 1 prospective study found no subsequent decline in quality of life (QOL), and another prospective study observed a significant increase in time without disease symptoms or toxicity (8.33 months) and less time spent in relapse. Both rituximab maintenance (after successful induction) and retreatment at progression were associated with a decline in illness-related anxiety (1randomized, Phase III trial in indolent non-Hodgkin lymphoma), while rituximab maintenance was associated with significantly decreased pain and other illness-related symptoms vs observation (2 studies). Five studies (3 US; 2 ex-US) analyzed infusion-related reactions (IRRs) and/or rapid infusion use. Overall, IRRs, especially with first infusions, were common (40%-63%), but primarily low-grade (I-II), and rituximab was usually well-tolerated on same-day rechallenge. Marked patient time was saved with rapid infusion. An SLR and meta-analysis of rapid rituximab infusion further characterized rapid infusion, identifying all IRRs as Grade I or II with a pooled incidence of 2.6%. Three ex-US studies evaluated economic endpoints comparing intravenous and subcutaneous (SC) preparation and administration of rituximab. One study calculated higher labor costs for SC rituximab, while 2 studies calculated lower staff time for SC rituximab; all studies identified shorter patient treatment/chair time for SC rituximab.CONCLUSIONS: We found that the treatment-related cost burden of rituximab in malignant conditions is substantial, while its associated toxicity is relatively low, and patient QOL is maintained or improved. Incident and increased toxicities associated with rituximab added to CT may or may not be exclusively attributable to rituximab. Administration rate and route influence economic endpoints with rituximab use. These findings highlight the potential economic benefit of lower-cost biosimilar rituximab products for patients, health care systems, and payers.[1] This Abstract is not intended to refer to any particular biosimilar product or use thereof. DisclosuresJames:Teva: Consultancy; Roche: Consultancy. Trautman:Teva: Consultancy; Roche: Consultancy. Hoehn:Teva: Employment. Szabo:Teva: Employment. Tang:Teva: Employment.

Rapid infusion rituximab is well tolerated in patients with primary CNS lymphoma.

Aim:To establish the safety and feasibility of rapidly infusing rituximab over 90 min in patients with primary CNS lymphoma (PCNSL).Patients & methods:We retrospectively reviewed all patients with PCNSL who received rapid rituximab infusions (RRI) from January 2016 to January 2017. Primary end point was incidence of infusion reactions.Results & conclusion:11 patients received a total of 44 RRIs. Rituximab was dosed at 500 or 750 mg/m2. Premedication included acetaminophen and diphenhydramine. No infusion reactions occurred during any RRI. Two infusions were administered with steroids for neurologic symptoms at baseline (4.5%). Rapid administration of rituximab was safe and feasible for patients with PCNSL and at the higher doses received.

Sixty-minute infusion rituximab protocol allows for safe and efficient workflow.

Rituximab is a chimeric monoclonal antibody approved to treat B cell non-Hodgkin's lymphoma (NHL). Infusion reactions among NHL patients are common during the first exposure but decrease with subsequent infusions. We sought to assess the safety and feasibility of a rituximab rapid infusion protocol in the outpatient treatment area of a comprehensive cancer center. Patients with indolent and intermediate B cell NHL were invited to enroll in this prospective, single-institution study if they had received the first dose of rituximab according to the manufacturer-labeled standard titration schedule without grade >2 infusion reaction. The subsequent infusion proceeded without the use of steroid premedication at 100 mg/h administered over 15 min, with the remaining dose given over 45 min. Time savings between rapid infusion and standard titration were calculated. Fifty patients received 60-min rituximab infusions during the second drug administration. No infusion-related reactions of any grade were observed with the rapid infusion protocol (0%, one-sided 97.5% CI 0-7.1%). The mean time for the rapid rituximab infusion was 62.4 min (95% CI 61.2-63.6). When compared to the standard second dose infusion recommendation, a mean time of 94.2 min (95% 90-98.4) was saved with rapid infusion. Nursing surveys demonstrated 100% satisfaction with the rapid infusion protocol. Subsequent rituximab infusions can be safely administered over 60 min and without steroid premedication in an experienced outpatient infusion center when patients are appropriately screened. The faster infusions can reduce resource utilization and increase nursing satisfaction. NCT01206777.

Safety and efficacy of non-initial rapid infusion of rituximab plus chemotherapy in Chinese patients with CD20+ non-Hodgkin’s lymphoma

Objective: To evaluate the safety and efficacy of rapid rituximab infusion (RRI) plus chemotherapy in patients with CD20+ non-Hodgkin’s lymphoma (NHL).Research design and methods: A total of 177 patients received 4 – 6 cycles of rituximab-based chemotherapy. The first cycle was given with standard schedule. In the second and subsequent cycles, RRI was initiated. Rituximab was administered as 20% of the dose infused in the first 30 min and the remaining 80% was given over 60 min. Benadryl and dexamethasone were given before infusions. Vital signs were measured at baseline and during infusion.Results: In the first cycle, 48 patients experienced grade I – II infusion reactions and two patients showed grade III – IV infusion reactions. Six patients experienced infusion reactions during RRI. Two patients showed grade III infusion reactions to RRI and dropped out of the study. With a median follow up of 37.5 months, the 3-year overall survival and progression-free survival rates of the whole cohort were 93.1 and 81.1%, respectively.Conclusions: Our preliminary observations suggested that RRI may be safe and feasible for patients with CD20+ NHL.

SAT0247 Safety of RAPID Rituximab Infusion in Rheumatoid Arthritis in A Single Community Practice

BackgroundRituximab, a chimeric monoclonal anti-CD20 antibody, is approved to be infused over 4hours and 15minutes, due to the potential for infusion reactions. The risk of infusion reactions has been shown...

Use of a Pharmacy Protocol to Convert Standard Rituximab Infusions to Rapid Infusion Shortens Outpatient Infusion Clinic Visits

To evaluate the impact of a pharmacy protocol that converts standard rituximab infusions to a rapid 90-minute infusion on the duration of outpatient infusion center clinic visits. Prospective interventional study. Outpatient infusion clinic at an academic medical center. Sixty-four adults who received at least one rituximab infusion that was eligible for conversion to rapid infusion between August 2010 and July 2011 and who did not receive concurrent chemotherapy or colony-stimulating agents during the same clinic visit. Of the 64 patients, 37 received the rapid infusion (intervention cohort); 27 received the nonrapid infusion (control cohort). Using a hospital-approved protocol, pharmacists converted rituximab infusions that met eligibility criteria (noninitial rituximab infusion, rituximab given in the previous 90days, age 18yrs or older, dose 375mg/m(2) or less per infusion, dose 1000mg or less per infusion, and no history of a grade 3 or higher reaction) to a rapid 90-minute infusion. The durations of rituximab infusion time and clinic visit time were evaluated and compared between the intervention cohort and the control cohort. Use of the pharmacy protocol to convert standard rituximab infusion to rapid rituximab infusion reduced infusion time by 110.5minutes/infusion (median 94.5min [interquartile range (IQR) 90-105min] for rapid infusion vs 205min [IQR 138-263min] for nonrapid infusion; p<0.001) and reduced clinic visit time by 92minutes/outpatient encounter (median 233min [IQR 208-277] min for rapid infusion vs 325min [IQR 275-415min] for nonrapid infusion; p<0.001). This resulted in a reduction of the duration of outpatient clinic visits by an estimated 255-299hours in 1year. Use of a pharmacist protocol that converted standard rituximab infusions to a rapid 90-minute infusion decreased the duration of outpatient infusion clinic visits for rituximab infusion.

Rapid Rituximab and Infliximab Infusions in Pediatric HSCT Patients Are Well Tolerated

Rapid Rituximab and Infliximab Infusions in Pediatric HSCT Patients Are Well Tolerated

Is rituximab one for all ages and each sex?

In this issue of Blood, Pfreundschuh et al report that young males treated with rituximab-based immunochemotherapy in contrast to elderly males benefit as much as females from rituximab immunochemotherapy and patients with more rapid rituximab clearance have reduced therapeutic benefit.

Prediction of Adverse Events in Patients Receiving Rapid Rituximab Infusion

Rapid rituximab infusion was approved as treatment for non-Hodgkin lymphoma by the U.S. Food and Drug Administration in 2012, but it has been administered clinically since approval of the drug rituximab in 1997. Because of the delay between the approval of the drug and the approval of the procedure, researchers sought to discover predictors for adverse events related to rapid rituximab infusion. The current study is a retrospective cohort study using medical records from a cancer center in Singapore. The purpose of the study is to validate whether high absolute lymphocyte counts can predict the occurrence of adverse events from rapid rituximab infusion over 90-minute intervals. A total of 120 patients were selected by purposive sampling, and 394 cycles of rapid rituximab infusions were available for analysis. The authors found that high absolute lymphocyte count is highly specific in identifying patients who will not experience any adverse event from rapid rituximab infusion. However, lack of sensitivity can occur when screening potential patients for adverse events.

Indications, Protocols, and Outcomes of Drug Desensitizations for Chemotherapy and Monoclonal Antibodies in Adults and Children

Advances in the understanding of various malignancies and chronic inflammatory diseases has led to the development of better treatment options for prolonging patient survival and minimizing morbidity. The recognition of "first-line" chemotherapy and monoclonal agents for these conditions has given more urgency to the need to re-administer these drugs in cases of drug hypersensitivity reactions. Therefore, in these cases, not only is desensitization considered when there is no alternative therapy available but also when alternative treatments are considered therapeutically inferior and/or more toxic. In this article, we describe the steps involved in the evaluation of these patients, factors to consider before making a decision to desensitize, the implementation of desensitization protocols, and the outcomes of such procedures.

Rapid Infusion Rituximab for Maintenance Therapy: Is It Feasible?

Rituximab is an anti-CD-20 monoclonal antibody used in the management of lymphoproliferative disorders. The use of maintenance rituximab has improved progression free survival and overall survival in follicular lymphomas. Although rapid rituximab infusions have been studied extensively, there is little data on the use of rapid infusions during maintenance therapy for low grade lymphomas. The primary objective of this retrospective analysis was to evaluate the incidence of Grade 3 and 4 toxicities with maintenance rapid infusion rituximab according to the Common Terminology Criteria for Adverse Events version 4 (CTC v. 4). Secondary objectives included evaluating all grade infusion related adverse events and correlation of adverse events with varying schedules of rituximab maintenance therapy. All patients who received rapid infusion rituximab as maintenance therapy for low grade lymphoma between December 2007 and November 2011 were included. Rapid rituximab infusions were administered over 90 minutes. Demographic, laboratory and clinical data were collected. A total of 109 patients received 647 rapid rituximab infusions. Three patients experienced an adverse reaction which resulted in one grade 1 infusion reaction and three grade 3 infusion reactions. No patients required hospitalization. All 3 patients received pharmacological and/or supportive care to relieve symptoms associated with the reaction.

AB0619 Safety of rapid rituximab infusion in systemic autoimmune diseases

BackgroundThe use of Rituximab in vasculitis, systemic lupus erythematosus and some other systemic autoimmune diseases reduces activity of process. It also demonstrated the low rate of disease progression. The standard...