Evidence map›Paper›PMID 36239134›Full record

ArticleTransfusion2022

Anti-CD38 monoclonal antibody interference with blood compatibility testing: Differentiating isatuximab and daratumumab via functional epitope mapping.

Btissam Chami, Makoto Okuda, Morvarid Moayeri, France Pirenne, Yoko Hidaka, Ashok Nambiar, Zhili Song, Olivier Bedel, Bailin Zhang, Joern Hopke and 8 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Transfusion, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03275285 (Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.8field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03275285 phase3completednot on this map

Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines

TypeinterventionalSponsorSanofiRan2017 to 2025Enrolled302ConditionsPlasma Cell MyelomaArmsisatuximab SAR650984, carfilzomib, dexamethasone
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. Evorpacept-Induced Interference and Application of a Novel Mitigation Agent, Evo-NR, in Pretransfusion Testing.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2024
    Article
  10. Article
  11. Article
  12. Article
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 7 institutions in 3 countries.

Btissam ChamiÉtablissement Français du Sang Île-de-France, Paris, France.ORCID 0000-0002-0703-4209
Makoto OkudaToho University Medical Center Omori Hospital, Tokyo, Japan.
Morvarid MoayeriTransfusion Service, University of California San Francisco, San Francisco, California, USA.ORCID 0000-0001-5752-4997
France PirenneÉtablissement Français du Sang Île-de-France, Paris, France.ORCID 0000-0003-3547-3994
Yoko HidakaToho University Medical Center Omori Hospital, Tokyo, Japan.
Ashok NambiarTransfusion Service, University of California San Francisco, San Francisco, California, USA.
Zhili SongSanofi, Global Oncology, Cambridge, Massachusetts, USA.
Olivier BedelSanofi, Global Oncology, Cambridge, Massachusetts, USA.
Bailin ZhangSanofi, Global Oncology, Cambridge, Massachusetts, USA.
Joern HopkeSanofi, Large Molecule Research, Cambridge, Massachusetts, USA.
Gejing DengSanofi, Global Oncology, Cambridge, Massachusetts, USA.
Chen ZhuSanofi, Global Oncology, Cambridge, Massachusetts, USA.
Sandrine MacéSanofi, Research and Development, Paris, France.
Marielle ChironSanofi, Research and Development, Paris, France.
Francisco AdrianSanofi, Global Oncology, Cambridge, Massachusetts, USA.
Taro FukaoSanofi, Global Oncology, Cambridge, Massachusetts, USA.
Frank G BasileSanofi, Global Oncology, Cambridge, Massachusetts, USA.
Thomas MartinHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California, USA.
Sanofi (United States) · USUniversity of California, San Francisco · USÉtablissement Français du Sang · FRSanofi (France) · FRToho University · JPAmgen (United States) · USHiFiBiO Therapeutics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are two FDA-approved anti-CD38 monoclonal antibodies for treatment of multiple myeloma: isatuximab and daratumumab. Owing to expression of CD38 on reagent red blood cells (RBCs), these antibodies interfere with indirect antiglobulin tests (IATs). We sought to understand differences in such interference by performing binding experiments. STUDY DESIGN AND

methodsIn vitro experiments to compare the binding to RBCs of isatuximab and daratumumab alone or in the presence of a mouse anti-human CD38 antibody (HB-7 or AT13/5) or a nicotinamide adenine dinucleotide-analog CD38 inhibitor were performed and quantified by flow cytometry, imaging, mass spectrometry, surface plasmon resonance, and LigandTracer technologies. Serologic testing was performed on plasma samples spiked with isatuximab or daratumumab.

resultsCD38 expressed on RBCs can be directly bound by daratumumab, whereas isatuximab requires a co-factor, such as HB-7, AT13/5, or a CD38 inhibitor, suggesting that the isatuximab epitope on RBCs is masked in vitro. Daratumumab samples more frequently showed interference and had stronger reactions than isatuximab samples. Dithiothreitol treatment was equally effective in mitigating the interference caused by either drug. DISCUSSION: Both isatuximab and daratumumab interfere with IATs but at different magnitudes, reflecting distinct binding to CD38 on RBCs. From the binding studies, we conclude that the isatuximab epitope on RBCs is masked in vitro and binding requires a certain CD38 conformation or co-factor. This circumstance may explain why interference is seen only in a subset of patients receiving isatuximab when compared with interference seen in most patients on daratumumab therapy.

Indexed as

Antineoplastic AgentsMultiple MyelomaNeuroblastomaADP-ribosyl Cyclase 1AnimalsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedEpitope MappingEpitopesMiceADP-ribosyl Cyclase 1Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsdaratumumabEpitopesisatuximab

Identifiers

PMID36239134
PMCPMC9828815
OpenAlexW4306166099

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.