| アブストラクト | 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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| 投稿者 | Neubauer, David; Palassin, Pascale; Ram-Wolff, Caroline; Masson, Adele De; Delaleu, Jeremie; Kottler, Diane; Amatore, Florent; Adamski, Henri; Bejar, Claudia; Janela-Lapert, Raphael; Guenova, Emmanuella; Bernard, Pauline; Lheure, Coralie; Machet, Laurent; Troin, Laura; Quereux, Gaelle; Pham-Ledard, Anne; Faiz, Sarah; Grange, Florent; Corre, Yannick Le; Nikkels, Arjen; Barete, Stephane; Manea, Lorena; Amazan, Emmanuelle; Maria, Alexandre Tj; Moulis, Lionel; Dereure, Olivier; Samaran, Quentin |
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| 組織名 | Department of Dermatology, Montpellier University Hospital and Montpellier;University, Montpellier, France.;Service de Pharmacologie Medicale et Toxicologie, CHU de Montpellier,;Montpellier, France.;Service de Dermatologie, Hopital Saint Louis, Assistance Publique-Hopitaux de;Paris (AP-HP), Paris, France.;Service de Dermatologie, CHU de Caen, Caen, France.;Service de Dermatologie, Hopital Nord, Assistance Publique Des Hopitaux de;Marseille et Universite d'Aix Marseille, Marseille, France.;Service de Dermatologie, CHU de Rennes, Rennes, France.;Service de Dermatologie, Hopital Avicenne, Assistance Publique-Hopitaux de Paris;(AP-HP), Bobigny, France.;Service de Dermatologie, CHU de Rouen, Rouen, France.;Department of Dermatology, Lausanne University Hospital CHUV, Faculty of Biology;and Medicine, University of Lausanne, Lausanne, Switzerland.;Service de Dermatologie, Hopital Cochin, Assistance Publique-Hopitaux de Paris;(AP-HP), Paris, France.;Service de Dermatologie, CHU de Tours, Tours, France.;Service de Dermatologie, CHU de Nice, Nice, France.;Service de Dermatologie, CHU de Nantes, CIC 1413, Inserm UMR 1302/EMR6001 INCIT,;Nantes, France.;Service de Dermatologie, CHU de Bordeaux, BoRdeaux Institute of Oncology, BRIC;INSERM U1312, INSERM BoRdeaux Institute of onCology, Team 5, Universite de;Bordeaux, Bordeaux, France.;Service de Dermatologie, CHU de Lille, Lille, France.;Service de Dermatologie, CH de Valence, Valence, France.;Service de Dermatologie, CHU d'Angers, Angers, France.;Service de Dermatologie, Skin Cancer Center, ICAB, University Hospital Centre,;CHU du Sart Tilman, Liege, Belgium.;Service de Dermatologie, Hopital de la Pitie-Salpetriere, Assistance;Publique-Hopitaux de Paris (AP-HP), Paris, France.;Service de Dermatologie, CHU de Martinique, Fort de France, Martinique.;Department of Internal Medicine and Clinical Immunology, Internal Medicine and;Immuno-Oncology (MedI2O) Mobile Team, Montpellier University Hospital, Univ;Montpellier, Montpellier, France.;Clinical Research and Epidemiology Unit, CHU Montpellier, Univ Montpellier,;Pathogenesis and Control of Chronic and Emerging Infections (PCCEI), Univ;Montpellier, INSERM, Univ Antilles, CHU Montpellier, Montpellier, France.;Epilogy (Epidemiology in Dermatology and Evaluation of Therapeutics), IMRB,;INSERM, Univ Paris-Est Creteil, Creteil, France. |
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