Practical approaches and costs for provisioning safe transfusions during anti‐CD38 therapy

Anani, Waseem Q.; Marchan, Marisela G.; Bensing, Kathleen M.; Schanen, Michael; Piefer, Cindy; Gottschall, Jerome L.; Denomme, Gregory A.

doi:10.1111/trf.14021

Cited by 23 publications

(37 citation statements)

References 26 publications

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“…The majority (65.9%) of our study's cohort, however, did not receive RBC transfusions over the 1‐year follow‐up period; the cost savings in the GPSR approach observed by Anani et al required that patients receive at least 1 RBC unit (1–22 total RBC units), depending on the number of antigens matched per unit. In our practice, reserving genotyping for immunized patients was the most cost‐effective strategy, as RBC transfusions were not required in many DARA patients . Transfusion services must individualize their approach based on their DARA patients’ transfusion burden to optimize cost savings.…”

Section: Discussionmentioning

confidence: 75%

“…When Anani et al modeled a higher transfusion burden for DARA patients (more patients transfused, with a greater number of RBC units transfused per patient), a GPSR approach became more cost effective. The majority (65.9%) of our study's cohort, however, did not receive RBC transfusions over the 1‐year follow‐up period; the cost savings in the GPSR approach observed by Anani et al required that patients receive at least 1 RBC unit (1–22 total RBC units), depending on the number of antigens matched per unit. In our practice, reserving genotyping for immunized patients was the most cost‐effective strategy, as RBC transfusions were not required in many DARA patients .…”

Section: Discussionmentioning

confidence: 99%

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The impact of Daratumumab on transfusion service costs

et al. 2019

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BACKGROUND Daratumumab (DARA) is a human IgG1κ monoclonal antibody directed against CD38, approved for the treatment of multiple myeloma. As CD38 is expressed on RBCs, DARA can interfere with pretransfusion testing. DARA interference can be negated by denaturation of CD38 on RBCs with dithiothreitol (DTT) reagents. Because of this interference in pretransfusion testing, our hospital implemented a notification and testing/transfusion algorithm (NATTA) for pretransfusion testing and RBC product provision for DARA patients. This standardized approach combines DTT‐based testing with selective genotyping and the provision of phenotypically similar RBCs for patients with clinically significant antibodies. STUDY DESIGN AND METHODS We evaluated pretransfusion test results and transfusion requirements for 91 DARA patients in an academic medical center over 1 year to determine the incremental cost of pretransfusion testing and RBC selection. The actual costs for the NATTA approach were compared to a theoretical approach using universal genotyping with a provision of phenotypically similar RBC transfusions. RESULTS The annual cost of testing related to DARA after NATTA implementation was $535.76 per patient. The simulated annual cost for the alternative genotyping with provision of phenotypically similar RBC transfusions approach was $934.83 per patient. CONCLUSION In our entire cohort of DARA patients, a DTT‐based testing algorithm with selective genotyping and provision of phenotypically similar RBCs only for patients with clinically significant antibodies was less expensive than a simulated model of universal genotyping and provision of phenotypically similar RBCs.

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Section: Discussionmentioning

confidence: 75%

Section: Discussionmentioning

confidence: 99%

The impact of Daratumumab on transfusion service costs

et al. 2019

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“…Donor units with extended antigen profiles are increasingly requested for patients receiving chronic transfusion to prevent alloimmunization, particularly to C, E, and K as common causes of sensitization . Extended antigen typed blood is also used for antigen matching (providing donor units negative for clinically significant antigens the recipient lacks) for patients with warm autoantibodies when compatibility cannot be demonstrated and underlying alloantibodies cannot, or have not, been ruled out, and is also an option for patients receiving monoclonal antibody therapies that interfere in pre‐transfusion testing …”

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confidence: 99%

Reliability of labeling red cell units with minor antigen historical results and process considerations

et al. 2020

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BACKGROUND Several approaches are used by blood centers when providing minor (non‐ABO/D) antigen‐negative RBCs to hospitals. Details vary but include providing results on the unit labeling intended for clinical use without retyping or providing results on packing documents or via computer query requiring confirmation. Recent regulatory changes allow labeling with historical minor antigen results, defined as previously performed by the donor center on two different donations with results linked to the donor and confirmed concordant. Here we investigate causes of discrepancies and identify critical process steps. STUDY DESIGN AND METHODS Nine years (2009‐2017) of data were reviewed for number, antigen system, and root cause of discrepancies flagged by the computer when retyping donors prior to labeling (internal discrepancies) or reported by the hospital when retested (external discrepancies). Licensed automated (CcEeK) and tube methods were used. RESULTS Among 300,000 samples phenotyped for CcEe, K, Fya/b, Jka/b, Ss (>3 million antigens), ∼1,389,960 were repeated on 2nd donation with 397 (1/3501) discordant; 205 Fy, 118 Rh, and 74 others. Of ∼682,691 antigen‐negative phenotypes provided on unit labeling, ∼37.5% (256,118) were retyped by hospitals with 29 discrepancies (1/8832), primarily Rh variants. CONCLUSION When repeating minor antigen types by serology, discrepancies are primarily associated with weak Fyb, among Caucasian donors, and weak/partial Rh antigens in donors of African ancestry. DNA‐based testing avoids these. To label with historical results, accuracy is increased by automated testing with direct computer interface. Testing on two donations with results confirmed to be concordant is not inferior to testing on the current donation.

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“…The use of soluble CD38 and anti‐CD38 idiotype are alternatives to the BMAP that, similarly, do not compromise the evaluation of any blood group system antigen. However, these methods have restricted applicability in daily practice because of the limited availability and high cost …”

Section: Discussionmentioning

confidence: 99%

“…representing a new challenge to blood banks worldwide. [8][9][10][11][12][13][14][15][16] CD38 is weakly expressed on normal human red blood cells (RBCs) and consequently anti-CD38 monoclonal antibodies can bind directly to CD38 expressed on RBCs, causing panreactivity in vitro. 9,17 Although DARA does not interfere with ABO/D typing, the plasma of DARA-treated patients consistently causes positive agglutination reactions in indirect antiglobulin tests (IATs), including antibody screening, antibody identification panels, and IAT crossmatches.…”

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confidence: 99%

A blockage monoclonal antibody protocol as an alternative strategy to avoid anti‐CD38 interference in immunohematological testing

et al. 2019

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BACKGROUND As CD38 is expressed on red blood cells (RBCs), the plasma of patients on daratumumab (DARA) reacts with the panel cells of pretransfusion tests, masking underlying alloantibodies. The treatment of RBCs with dithiothreitol (DTT) is the most disseminated method to overcome DARA effect on immunohematological tests, but it hampers the identification of potentially harmful antibodies. Our goal was to validate a new strategy, the blockage monoclonal antibody protocol (BMAP), to mitigate the DARA interference on RBCs using anti‐CD38 and antihuman globulin. METHODS Samples of patients receiving DARA were included in the study. Sera were tested using both DTT‐ and BMAP‐treated RBCs, which comprised three steps: 1) titration of monoclonal anti‐CD38, 2) treatment of RBCs obtained from donors with anti‐CD38, and 3) blockage of anti‐CD38–adsorbed RBCs with antihuman globulin. RESULTS Twenty patients were included in the study. Donor RBCs were treated with anti‐CD38 and successfully blocked with antihuman globulin. In 19 patients, DARA‐mediated agglutination was eliminated using both DTT‐ and BMAP‐treated RBCs. In one patient, agglutination persisted when tested against the BMAP‐treated RBCs, and alloantibodies were identified. Patient samples were mixed with commercial anti‐D, ‐C, −e, ‐K, −Jka, ‐Kpb and tested against antigen‐positive BMAP‐treated RBCs, resulting in detection of these antibodies. CONCLUSION This study validated a new strategy to minimize the interference of DARA on immunohematological tests. The protocol preserves the integrity of RBC antigens, permitting the detection of antibodies from all blood group systems. The BMAP has potential use in other situations where specific antibodies may interfere with pretransfusion screening.

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Practical approaches and costs for provisioning safe transfusions during anti‐CD38 therapy

Cited by 23 publications

References 26 publications

The impact of Daratumumab on transfusion service costs

The impact of Daratumumab on transfusion service costs

Reliability of labeling red cell units with minor antigen historical results and process considerations

A blockage monoclonal antibody protocol as an alternative strategy to avoid anti‐CD38 interference in immunohematological testing

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