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. 2025 Jul 4;30(7):oyaf201.
doi: 10.1093/oncolo/oyaf201.

Pharmacovigilance study for the identification of mogamulizumab-induced immune-related adverse events using a real-world database

Koji Miyata  1 , Yuki Izawa-Ishizawa  1 , Takahiro Niimura  1   2 , Toshihiko Yoshioka  1   3 , Mizusa Hyodo  1 , Shuto Itokazu  1 , Tatsumi Miyata  1 , Fuka Aizawa  1   3 , Kenta Yagi  1   2 , Kei Kawada  1 , Hirofumi Hamano  4 , Yoshito Zamami  4 , Mitsuhiro Goda  1   3 , Keisuke Ishizawa  1   2   3
Affiliations

Pharmacovigilance study for the identification of mogamulizumab-induced immune-related adverse events using a real-world database

Koji Miyata et al. Oncologist. .

Abstract

Background: Mogamulizumab is a humanized anti-CCR4 monoclonal antibody used for relapsed/refractory adult T-cell leukemia, cutaneous T-cell lymphoma, and/or Sézary syndrome. Reports of immune-related adverse events (irAEs) in these patients are increasing, and the association between irAEs and mogamulizumab remains to be elucidated. This study aimed to evaluate the association between mogamulizumab and immune-related adverse events (irAEs), as well as to characterize the irAEs associated with mogamulizumab using data from a large-scale spontaneous reporting system.

Methods: We performed an exploratory hypothesis-generating analysis of patients from 1967 to September 2023 using VigiBase, a World Health Organization spontaneous adverse event reporting system database. We performed a disproportionality analysis and determined the reporting odds ratios and information components between the drugs of interest and each irAE.

Results: Mogamulizumab was associated with some irAEs, including myocarditis, severe cutaneous adverse reactions, hepatitis, and myositis. Mogamulizumab exhibited significantly higher reporting rates of these 4 irAEs compared to the anticancer agents other than mogamulizumab. Conversely, the reporting rate of other irAEs, including endocrine autoimmune diseases induced by immune checkpoint inhibitors, was not significant in patients who received mogamulizumab.

Conclusions: Mogamulizumab is associated with irAEs, including myocarditis, severe cutaneous adverse reactions, hepatitis, and myositis.

Keywords: VigiBase; disproportionality analysis; irAEs; mogamulizumab; sézary syndrome.

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Conflict of interest statement

Authors declare no competing interests.

Figures

Figure 1.
Figure 1.
Disproportionality analysis of mogamulizumab and immune-related adverse events (irAEs). Information components (IC) (A) and reporting odds ratios (ROR) (B) of mogamulizumab for immune-related adverse events (irAEs) compared to the overall database. RORs of irAEs not reported in mogamulizumab reports are not displayed. The plots and lines represent the ROR and IC with 95% confidence intervals. A significantly high ROR or IC of the irAE is defined as the lower limit of the 95% confidence interval exceeding the dotted line, and the dotted line indicates ROR = 1 or IC = 0.
Figure 2.
Figure 2.
Disproportionality analysis of mogamulizumab and immune-related adverse events (irAEs) in the subgroup. Reporting odds ratios (ROR) of mogamulizumab for immune-related adverse events (irAEs) compared to post-2013 reports (Dataset 2) (A), Covid-19 vaccine-excluded reports (Dataset 3) (B), and anticancer drug-specific reports (Dataset 4) (C) are displayed. RORs of irAEs not reported in mogamulizumab reports are not displayed. The plots and lines represent ROR with 95% confidence intervals. The significant ROR of the irAE is defined as the lower limit of the 95% confidence interval exceeding the dotted line, and the dotted line indicates ROR = 1.
See this image and copyright information in PMC

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