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


Journal

Transfusion
ISSN: 1537-2995
Titre abrégé: Transfusion
Pays: United States
ID NLM: 0417360

Informations de publication

Date de publication:
11 2022
Historique:
revised: 02 08 2022
received: 20 08 2021
accepted: 20 08 2022
pubmed: 15 10 2022
medline: 10 11 2022
entrez: 14 10 2022
Statut: ppublish

Résumé

There 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. In 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. CD38 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. 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.

Sections du résumé

BACKGROUND
There 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 METHODS
In 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.
RESULTS
CD38 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.

Identifiants

pubmed: 36239134
doi: 10.1111/trf.17137
pmc: PMC9828815
doi:

Substances chimiques

daratumumab 4Z63YK6E0E
isatuximab R30772KCU0
ADP-ribosyl Cyclase 1 EC 3.2.2.6
Antibodies, Monoclonal 0
Antineoplastic Agents 0
Epitopes 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2334-2348

Informations de copyright

© 2022 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.

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Auteurs

Btissam Chami (B)

Établissement Français du Sang Île-de-France, Paris, France.

Makoto Okuda (M)

Toho University Medical Center Omori Hospital, Tokyo, Japan.

Morvarid Moayeri (M)

Transfusion Service, University of California San Francisco, San Francisco, California, USA.

France Pirenne (F)

Établissement Français du Sang Île-de-France, Paris, France.

Yoko Hidaka (Y)

Toho University Medical Center Omori Hospital, Tokyo, Japan.

Ashok Nambiar (A)

Transfusion Service, University of California San Francisco, San Francisco, California, USA.

Zhili Song (Z)

Sanofi, Global Oncology, Cambridge, Massachusetts, USA.

Olivier Bedel (O)

Sanofi, Global Oncology, Cambridge, Massachusetts, USA.
Worked for Sanofi at the time of study, currently at Amgen, Thousand Oaks, California, USA.

Bailin Zhang (B)

Sanofi, Global Oncology, Cambridge, Massachusetts, USA.

Joern Hopke (J)

Sanofi, Large Molecule Research, Cambridge, Massachusetts, USA.

Gejing Deng (G)

Sanofi, Global Oncology, Cambridge, Massachusetts, USA.

Chen Zhu (C)

Sanofi, Global Oncology, Cambridge, Massachusetts, USA.

Sandrine Macé (S)

Sanofi, Research and Development, Paris, France.

Marielle Chiron (M)

Sanofi, Research and Development, Paris, France.

Francisco Adrian (F)

Sanofi, Global Oncology, Cambridge, Massachusetts, USA.
Worked for Sanofi at the time of the study, currently at HiFiBio Therapeutics, Cambridge, Massachusetts, USA.

Taro Fukao (T)

Sanofi, Global Oncology, Cambridge, Massachusetts, USA.

Frank G Basile (FG)

Sanofi, Global Oncology, Cambridge, Massachusetts, USA.
Worked for Sanofi at the time of the study, currently at, Nurix Therapeutics, San Francisco, California, USA.

Thomas Martin (T)

Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California, USA.

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Classifications MeSH