Immune‐related adverse events with mogamulizumab in cutaneous T‐cell lymphoma: A multicentre study
Year: 2026
Type: article
Study design: Observational 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.
DOI: 10.1111/jdv.70770
Authors: David Neubauer, Pascale Palassin, Caroline Ram‐Wolff, Adèle De Masson, Jeremie Delaleu, Diane Kottler, Florent Amatore, Henri Adamski, Claudia Bejar, Raphaël Janela‐Lapert, Emmanuella Guenova, Pauline Bernard, Coralie Lheure, Laurent Machet, Laura Troin, Gaëlle Quereux, Anne Pham‐Ledard, Sarah Faiz, Florent Grange, Yannick Le Corre, Arjen Nikkels, Stéphane Barete, Lorena Manea, Emmanuelle Amazan, Alexandre Tj Maria, Lionel Moulis, Olivier Dereure, Quentin Samaran, For the Groupe Français d'Étude des Lymphomes Cutanés (GFELC)
Institutions: Université de Montpellier, Centre Hospitalier Universitaire de Montpellier, Assistance Publique – Hôpitaux de Paris, Hôpital Saint-Louis, Centre Hospitalier Universitaire de Caen Normandie, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille, Hôpital Nord, Centre Hospitalier Universitaire de Rennes, Hôpital Avicenne, Centre Hospitalier Universitaire de Rouen, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Hôpital Cochin, Centre Hospitalier Universitaire de Tours, Centre Hospitalier Universitaire de Nice, Inserm, Centre Hospitalier Universitaire de Nantes, Centre d'Investigation Clinique de Nantes, Immunologie et Nouveaux Concepts en Immunothérapie, Université de Bordeaux, Bordeaux Population Health, Centre Hospitalier Universitaire de Lille, Centre Hospitalier de Valence, Centre Hospitalier Universitaire d'Angers, Centre Hospitalier Universitaire de Liège, Pitié-Salpêtrière Hospital, Centre Hospitalier Universitaire de Martinique, Pathogenesis and Control of Chronic and Emerging Infections, Université Paris-Est Créteil, Institut Mondor de Recherche Biomédicale, Epidemiology in dermatology and evaluation of therapeutics
Language: English
Subfield: Dermatology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,450
OpenAlex ID: W7214699198