Evidence map›Paper›PMID 40083393›Full record

ArticleNeurology. Clinical practice2025

Herpes Zoster Infections With Multiple Sclerosis Disease-Modifying Therapies: A Real-World Pharmacovigilance Study.

Alexandra Balshi, Grace Leuenberger, John Dempsey, Nova Manning, Ursela Baber, Jacob A Sloane

Erratum issuedAbstract read
In one paragraph

Article in Neurology. Clinical practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
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  3. Review
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  7. T lymphopenia in multiple sclerosis patients treated with ofatumumab: Even with consideration for CD3Multiple sclerosis journal - experimental, translational and clinical
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Alexandra BalshiDepartment of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; and.ORCID https://orcid.org/0000-0002-3202-6921
Grace LeuenbergerDepartment of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; and.ORCID https://orcid.org/0009-0008-2231-1826
John DempseyDepartment of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; and.ORCID https://orcid.org/0009-0006-7465-5749
Nova ManningDepartment of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; and.ORCID https://orcid.org/0009-0009-0814-6462
Ursela BaberDepartment of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; and.ORCID https://orcid.org/0009-0006-6595-240X
Jacob A SloaneDepartment of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; and.ORCID https://orcid.org/0000-0003-0028-3031

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and Objectives: Immunosuppressive multiple sclerosis (MS) disease-modifying therapies (DMTs) may increase the risk of opportunistic infections such as herpes zoster (HZ). We sought to evaluate the risk of HZ across various MS DMTs using publicly available pharmacovigilance reporting data. Methods: We queried the Food and Drug Administration Adverse Event Reporting System (FAERS) and OpenVigil 2.1 for reports of HZ involving immunosuppressive MS DMTs (ocrelizumab [OCR], ofatumumab [OFT], rituximab [RTX], natalizumab [NTZ], alemtuzumab, dimethyl fumarate and diroximel fumarate [DRF], fingolimod [FING], siponimod [SIP], ozanimod [OZ], mitoxantrone [MITO], cladribine [CLAD], and teriflunomide [TERF]) and calculated reporting odds ratios and their 95% CIs. Results: We identified 4,210 total reports of HZ across these MS DMTs. All had disproportionally higher RORs compared with all other FAERS medications. Alemtuzumab had the greatest reporting risk (ROR; 95% CI) (11.1; 9.7-12.6), followed by OCR (9.3; 8.6-10.0), FING (5.6; 5.2-6.0), CLAD (5.3; 3.7-4.2), NTZ (4.0; 3.7-4.2), RTX (3.8; 3.5-4.1), SIP (3.2; 2.4-4.2), DRF (3.1; 2.4-4.1), OFT (3.0; 2.6-3.6), dimethyl fumarate (2.5; 2.3-2.8), OZ (2.5; 1.8-3.6), MITO (2.4; 1.6-3.6), and TERF (1.6; 1.3-1.9). Discussion: Immunosuppressive MS DMTs are associated with greater HZ reporting in the FAERS. These findings emphasize the importance of pre-DMT HZ vaccination because of avoidable HZ infections.

Identifiers

PMID40083393
PMCPMC11902899

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.