Evidence map›Paper›PMID 41402606›Full record

Observational studyJournal of neurology2025

Guillain-Barré syndrome associated with immune checkpoint inhibitors exposure: a pharmacovigilance study.

Jean Cabon, Mathilde Ducloie, Basile Chretien, Charlotte Arnaud, Joachim Alexandre, Charles Dolladille, Angélique Da Silva

Abstract readObservational Study
In one paragraph

Observational study in Journal of neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Jean CabonDepartment of Pharmacology, Biology-Research Building, Caen-Normandy University Hospital, Avenue de La Côte de Nacre, 14000, Caen, France. cabon-je@chu-caen.fr.ORCID http://orcid.org/0009-0004-9933-7996
Mathilde DucloieNeurology Department, Caen-Normandy University Hospital, Avenue de La Côte de Nacre, 14000, Caen, France.
Basile ChretienDepartment of Pharmacology, Biology-Research Building, Caen-Normandy University Hospital, Avenue de La Côte de Nacre, 14000, Caen, France.
Charlotte ArnaudNeurology Department, Caen-Normandy University Hospital, Avenue de La Côte de Nacre, 14000, Caen, France.
Joachim AlexandreDepartment of Pharmacology, Biology-Research Building, Caen-Normandy University Hospital, Avenue de La Côte de Nacre, 14000, Caen, France.
Charles DolladilleDepartment of Pharmacology, Biology-Research Building, Caen-Normandy University Hospital, Avenue de La Côte de Nacre, 14000, Caen, France.
Angélique Da SilvaDepartment of Pharmacology, Biology-Research Building, Caen-Normandy University Hospital, Avenue de La Côte de Nacre, 14000, Caen, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGuillain-Barré syndrome (GBS) is a life-threatening condition that has been associated with exposure to immune checkpoint inhibitors (ICIs); however, available data remain limited.

methodsWe conducted a retrospective, worldwide, observational analysis of individual case safety reports in VigiBase, the World Health Organization's pharmacovigilance database. To minimize competition bias, we excluded reports of vaccines and infectious associated with a known or potential risk of GBS. Subsequently, we searched for reports of GBS linked to ICI regimens, whether as monotherapy or dual immunotherapy, from the Food and Drug Administration (FDA) approval date of each agent until 12 February 2024. The primary endpoint of this study was to assess the association between GBS reporting and exposure to ICI regimens (either monotherapy or dual immunotherapy) using disproportionality analysis. This analysis was performed utilizing the Information Component (IC) and its 95% credibility interval lower boundary (IC

resultsA total of 412 cases of GBS associated with ICIs were reported in VigiBase. The disproportionality analysis revealed a significant reporting signal between GBS and the anti-CTLA-4 and anti-PD-1 combination therapy (n = 102, IC

conclusionA significant reporting signal of GBS exists with the majority of ICI regimens employed in both monotherapy and dual immunotherapy.

Indexed as

Guillain-Barre SyndromeImmune Checkpoint InhibitorsPharmacovigilanceAdultAgedAntibodies, Monoclonal, HumanizedFemaleHumansMaleMiddle AgedNivolumabRetrospective StudiesAntibodies, Monoclonal, HumanizedImmune Checkpoint InhibitorsNivolumabGuillain–Barré SyndromeImmune Checkpoint InhibitorsNeurological immune-related adverse eventsPeripheral nervous systemPharmacogivilance database

Identifiers

PMID41402606
PMCPMC12708775

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.