Evidence map›Paper›PMID 33294815›Full record

ArticleEClinicalMedicine2020

Risk of hepatitis B reactivation and cytomegalovirus related infections with Mogamulizumab: A retrospective study of international pharmacovigilance database.

Shuai Wang, Apoorva Jayarangaiah, Mariuxi Malone, Tarek Elrafei, Lewis Steinberg, Abhishek Kumar

Abstract read
In one paragraph

Article in EClinicalMedicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. [Biologics and infections: understand and recognize].Dermatologie (Heidelberg, Germany) · 2026
    Review
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  3. Practical recommendations for therapy and monitoring of mogamulizumab patients in Germany.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025
    Review
  4. Review
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  7. Article
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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

6 authors.

Shuai WangDepartment of Internal Medicine, Albert Einstein College of Medicine, Jacobi Medical Center, Bronx, United States.
Apoorva JayarangaiahDepartment of Hematology-Oncology, Albert Einstein College of Medicine, Jacobi Medical Center, Bronx, United States.
Mariuxi MaloneDepartment of Hematology-Oncology, Albert Einstein College of Medicine, Jacobi Medical Center, Bronx, United States.
Tarek ElrafeiDepartment of Hematology-Oncology, Albert Einstein College of Medicine, Jacobi Medical Center, Bronx, United States.
Lewis SteinbergDepartment of Hematology-Oncology, Albert Einstein College of Medicine, Jacobi Medical Center, Bronx, United States.
Abhishek KumarDepartment of Hematology-Oncology, Albert Einstein College of Medicine, Jacobi Medical Center, Bronx, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMogamulizumab (Moga) is a C-C chemokine receptor-4 antibody approved in the United States for relapsed /refractory mycosis fungoides and Sézary syndrome. Few cases reported an increased risk of hepatitis B reactivation and cytomegalovirus (CMV) related infection post-Moga. However, literature is limited to mainly case reports and series, while no study has used the Food and Drug Administration adverse events reporting system (FARES) database to investigate the relationship.

methodsUsing United States Food and Drug Administration adverse events reporting system database, we collected all cases of hepatitis B reactivation and CMV related infection between January 1, 2011, and December 31, 2019, for Moga and other drugs. The reporting odds ratio (ROR) was calculated, which was considered significant when the lower limit of 95% confidence interval (CI) >1.

findingsThree hundred and thirty-eight total adverse cases were reported for Moga during the study period, with 261 cases reported indication for use, including cutaneous T cell lymphoma (47.04%), and adult T cell leukemia/lymphoma (30.18%). Eight cases were reported for hepatitis B reactivation with Moga use, compared to 2290 cases with other medications. The ROR is 143.67 (

interpretationA signal has been identified between Moga exposure and hepatitis B reactivation as well as CMV related infection. A consideration in future studies should be placed on determining the relationship and investigating the need for pre-treatment screening, close monitoring, and utilization of prophylaxis in this population-based on pre-treatment risks.

fundingNone.

Indexed as

Adult T cell leukemia/LymphomaCutaneous T cell lymphomaCytomegalovirusHepatitis BMogamulizumabMycosis FungoidesSézary Syndrome

Identifiers

PMID33294815
PMCPMC7700953

What OpenQuestion holds

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Registered trials

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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.