Evidence map›Paper›PMID 40637043›Full record

ArticleThe oncologist2025

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

Koji Miyata, Yuki Izawa-Ishizawa, Takahiro Niimura, Toshihiko Yoshioka, Mizusa Hyodo, Shuto Itokazu, Tatsumi Miyata, Fuka Aizawa, Kenta Yagi, Kei Kawada and 4 more

Abstract read
In one paragraph

Article in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Koji MiyataDepartment of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.ORCID 0009-0000-3954-6420
Yuki Izawa-IshizawaDepartment of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.
Takahiro NiimuraDepartment of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.
Toshihiko YoshiokaDepartment of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.
Mizusa HyodoDepartment of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.
Shuto ItokazuDepartment of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.
Tatsumi MiyataDepartment of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.
Fuka AizawaDepartment of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.
Kenta YagiDepartment of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.
Kei KawadaDepartment of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.
Hirofumi HamanoDepartment of Pharmacy, Okayama University Hospital, Okayama 700-8558, Japan.
Yoshito ZamamiDepartment of Pharmacy, Okayama University Hospital, Okayama 700-8558, Japan.
Mitsuhiro GodaDepartment of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.
Keisuke IshizawaDepartment of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, Tokushima 770-8503, Japan.ORCID 0000-0003-1971-7696

Funding

JST SPRING JPMJSP2113KAKENHI JP21H02646KAKENHI JP22K06863
6 · The paper itself

Abstract

backgroundMogamulizumab 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.

methodsWe 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.

resultsMogamulizumab 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.

conclusionsMogamulizumab is associated with irAEs, including myocarditis, severe cutaneous adverse reactions, hepatitis, and myositis.

Indexed as

Antibodies, Monoclonal, HumanizedDrug-Related Side Effects and Adverse ReactionsPharmacovigilanceAdultAdverse Drug Reaction Reporting SystemsAgedDatabases, FactualFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, Humanizedmogamulizumabdisproportionality analysisirAEsmogamulizumabsézary syndromeVigiBase

Identifiers

PMID40637043
PMCPMC12242157

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.