Effectiveness of mogamulizumab in patients with Mycosis Fungoides or Sézary syndrome. A multicentre, retrospective, real‐world French study - Inserm - Institut national de la santé et de la recherche médicale Accéder directement au contenu
Article Dans Une Revue Journal of the European Academy of Dermatology and Venereology Année : 2023

Effectiveness of mogamulizumab in patients with Mycosis Fungoides or Sézary syndrome. A multicentre, retrospective, real‐world French study

O. Dereure
V. Braniste

Résumé

Background: Efficacy and safety of mogamulizumab, a monoclonal antibody directed against C-C chemokine receptor 4, were demonstrated in a previous multinational clinical trial conducted in patients with previously treated cutaneous T-cell lymphoma (CTCL): Sézary syndrome (SS) or Mycosis Fungoides (MF). Objectives: The real-world French OMEGA study aimed to describe effectiveness and tolerability of mogamulizumab in adult patients with CTCL, overall and according to the disease (SS or MF). Methods: In this retrospective study, patients treated with mogamulizumab for SS or MF were included from 14 French expert centres. The overall response rate (ORR) under treatment was described (primary criterion), as well as treatment use and safety data. Results: The 122 analysed patients (69 SS, 53 MF) were aged 66.6 ± 12.1 years at mogamulizumab initiation, and their median disease duration was 2.5 years (IQR: 1.3-5.6). Prior to treatment start, they received a median of three systemic CTCL therapies (2-5). Overall, 77.8% of patients suffered from advanced disease (Stage IIB-IVB), with frequent blood (B1/B2) involvement (67.5%). Over the treatment period (median: 4.6 months, 2.1-7.2), 96.7% of patients received all the planned mogamulizumab infusions. Among the 109 patients evaluable for effectiveness, ORR was 58.7% (95% CI [48.9-68.1]) overall, 69.5% [56.1-80.8] in SS and 46.0% [31.8-60.7] in MF. Compartmental response in the blood was observed in 81.8% [69.1-90.9] of SS patients. Skin responses were observed in 57.0% [47.0-66.5] of patients overall, 66.7% [52.9-78.6] in SS and 46.0% [31.8-60.7] in MF. The most common serious adverse drug reactions were rash (8.1% of patients) and infusion-related reactions (2.4%) which led to treatment discontinuation in 7.3% and 0.8% of patients, respectively. One patient with SS died from mogamulizumab-related tumour lysis syndrome. Conclusions: This large French study confirmed the effectiveness and tolerability of mogamulizumab in SS and MF patients in routine medical practice.
Fichier principal
Vignette du fichier
Acad Dermatol Venereol - 2023 - Beylot‐Barry.pdf (220.45 Ko) Télécharger le fichier
Origine Publication financée par une institution
Licence

Dates et versions

inserm-04085051 , version 1 (28-04-2023)

Licence

Identifiants

Citer

M. Beylot-Barry, G. Quereux, C. Nardin, A.‐b. Duval-Modeste, O. Dereure, et al.. Effectiveness of mogamulizumab in patients with Mycosis Fungoides or Sézary syndrome. A multicentre, retrospective, real‐world French study. Journal of the European Academy of Dermatology and Venereology, 2023, Online ahead of print. ⟨10.1111/jdv.19134⟩. ⟨inserm-04085051⟩
18 Consultations
71 Téléchargements

Altmetric

Partager

Gmail Mastodon Facebook X LinkedIn More