Immune‐related adverse events with mogamulizumab in cutaneous T‐cell lymphoma: A multicentre study
Abstract
Background Mogamulizumab, an anti‐CCR4 monoclonal antibody used in advanced mycosis fungoides (MF) and Sezary syndrome (SS), also depletes regulatory T cells, potentially leading to immune‐related adverse events (irAEs). Unlike mogamulizumab‐associated rash (MAR), other irAEs remain poorly documented to date. Objectives To estimate the prevalence of mogamulizumab‐associated irAEs (excluding MAR), characterize their clinical profile and assess management strategies and outcome. Methods A retrospective nationwide multicentre survey was conducted using the French Study Group on Cutaneous Lymphomas (GFELC) database with standardized questionnaires collecting demographic, clinical and therapeutic data. An exploratory pharmacovigilance analysis was also performed using the WHO pharmacovigilance database, VigiBase. Results Among 403 treated patients from 19 participating centres, 34 patients (8.4%) experienced at least one irAE (41 events overall, event rate 10.2%). The most frequent irAEs involved the endocrine system, skin, and liver. Severe (grade ≥3) or serious irAEs occurred in about one‐third of cases, resulting in permanent treatment discontinuation in 29%. Most events occurred after several months of treatment, often in patients experiencing objective responses. In VigiBase (2464 reports), reported irAEs were most frequently digestive, musculoskeletal, cutaneous, and hepatic. Conclusions In this large retrospective series, a minority of patients developed irAEs during mogamulizumab treatment, although a substantial proportion were rated as severe and led to permanent treatment discontinuation. These findings highlight the need for systematic detection, as with immune checkpoint inhibitors, early recognition and prolonged monitoring, as irAEs may occur late during treatment. Prospective studies are warranted to refine epidemiological data along with diagnostic and therapeutic strategies.
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BibTeX
@article{neubauer2026immunerelated,
title = {{Immune‐related adverse events with mogamulizumab in cutaneous T‐cell lymphoma: A multicentre study}},
author = {David Neubauer and Pascale Palassin and Caroline Ram-Wolff and Adèle De Masson and Jeremie Delaleu and Diane Kottler and Florent Amatore and Henri Adamski and Claudia Bejar and Raphaël Janela-Lapert and Emmanuella Guenova and Pauline Bernard and Coralie Lheure and Laurent Machet and Laura Troin and Gaëlle Quereux and Anne Pham-Ledard and Sarah Faiz and Florent Grange and Yannick Le Corre and Arjen Nikkels and Stéphane Barete and Lorena Manea and Emmanuelle Amazan and Alexandre Tj Maria and Lionel Moulis and Olivier Dereure and Quentin Samaran},
journal = {Journal of the European Academy of Dermatology and Venereology},
year = {2026},
month = sep,
doi = {10.1111/jdv.70770},
url = {https://inserm.hal.science/inserm-05777932v1},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Immune‐related adverse events with mogamulizumab in cutaneous T‐cell lymphoma: A multicentre study
AU - David Neubauer
AU - Pascale Palassin
AU - Caroline Ram-Wolff
AU - Adèle De Masson
AU - Jeremie Delaleu
AU - Diane Kottler
AU - Florent Amatore
AU - Henri Adamski
AU - Claudia Bejar
AU - Raphaël Janela-Lapert
AU - Emmanuella Guenova
AU - Pauline Bernard
AU - Coralie Lheure
AU - Laurent Machet
AU - Laura Troin
AU - Gaëlle Quereux
AU - Anne Pham-Ledard
AU - Sarah Faiz
AU - Florent Grange
AU - Yannick Le Corre
AU - Arjen Nikkels
AU - Stéphane Barete
AU - Lorena Manea
AU - Emmanuelle Amazan
AU - Alexandre Tj Maria
AU - Lionel Moulis
AU - Olivier Dereure
AU - Quentin Samaran
PY - 2026
DA - 2026/09/29
JO - Journal of the European Academy of Dermatology and Venereology
DO - 10.1111/jdv.70770
UR - https://inserm.hal.science/inserm-05777932v1
AB - Background Mogamulizumab, an anti‐CCR4 monoclonal antibody used in advanced mycosis fungoides (MF) and Sezary syndrome (SS), also depletes regulatory T cells, potentially leading to immune‐related adverse events (irAEs). Unlike mogamulizumab‐associated rash (MAR), other irAEs remain poorly documented to date. Objectives To estimate the prevalence of mogamulizumab‐associated irAEs (excluding MAR), characterize their clinical profile and assess management strategies and outcome. Methods A retrospective nationwide multicentre survey was conducted using the French Study Group on Cutaneous Lymphomas (GFELC) database with standardized questionnaires collecting demographic, clinical and therapeutic data. An exploratory pharmacovigilance analysis was also performed using the WHO pharmacovigilance database, VigiBase. Results Among 403 treated patients from 19 participating centres, 34 patients (8.4%) experienced at least one irAE (41 events overall, event rate 10.2%). The most frequent irAEs involved the endocrine system, skin, and liver. Severe (grade ≥3) or serious irAEs occurred in about one‐third of cases, resulting in permanent treatment discontinuation in 29%. Most events occurred after several months of treatment, often in patients experiencing objective responses. In VigiBase (2464 reports), reported irAEs were most frequently digestive, musculoskeletal, cutaneous, and hepatic. Conclusions In this large retrospective series, a minority of patients developed irAEs during mogamulizumab treatment, although a substantial proportion were rated as severe and led to permanent treatment discontinuation. These findings highlight the need for systematic detection, as with immune checkpoint inhibitors, early recognition and prolonged monitoring, as irAEs may occur late during treatment. Prospective studies are warranted to refine epidemiological data along with diagnostic and therapeutic strategies.
SN - 0926-9959
SN - 1468-3083
ER -