Evidence map›Paper›PMID 34993569›Full record

ArticleEuropean journal of clinical pharmacology2022

Immune-mediated necrotizing myopathy with pembrolizumab: a specific neuromuscular entity.

Thierry Trenque, Elise Lepoix, Agathe Trenque, Aurore Morel, Brahim Azzouz

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In one paragraph

Article in European journal of clinical pharmacology, 2022. 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
0.8field-weighted citation impact, top 30% of its field
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, 6 citations in OpenAlex.

  1. Review
  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

5 authors at 1 institution in 1 country.

Thierry TrenqueDepartment of Pharmacovigilance and Pharmacoepidemiology, Reims University Hospital, Avenue du General Koenig, Reims, 51092, France. ttrenque@chu-reims.fr.ORCID http://orcid.org/0000-0002-5645-8366
Elise LepoixDepartment of Pharmacovigilance and Pharmacoepidemiology, Reims University Hospital, Avenue du General Koenig, Reims, 51092, France.
Agathe TrenqueDepartment of Pharmacovigilance and Pharmacoepidemiology, Reims University Hospital, Avenue du General Koenig, Reims, 51092, France.
Aurore MorelDepartment of Pharmacovigilance and Pharmacoepidemiology, Reims University Hospital, Avenue du General Koenig, Reims, 51092, France.
Brahim AzzouzDepartment of Pharmacovigilance and Pharmacoepidemiology, Reims University Hospital, Avenue du General Koenig, Reims, 51092, France.ORCID http://orcid.org/0000-0002-4395-2445
Centre Hospitalier Universitaire de Reims · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePembrolizumab is a humanized monoclonal antibody that binds to the programmed cell-death protein-1 (PD-1) on immune T-cells, thus blocking PD-1 activity. Pembrolizumab is indicated for the treatment of advanced melanoma, metastatic non-small-cell lung cancer, and head and neck squamous cell carcinoma. However, it is associated with immune-related adverse events.

methodsWe investigated the association between pembrolizumab and immune-mediated necrotizing myopathy (IMNM). We analyzed reports in the World Health Organization's global individual case safety report database, Vigibase, up to January 2020 with the MedDRA lower level term "IMNM." The association between exposure to pembrolizumab and occurrence of the adverse event was estimated by disproportionality analysis. The reporting odds ratio (ROR) was calculated with 95% confidence intervals (CIs). We analyzed the criteria of diagnosis of the adverse reaction.

resultsFive-hundred sixty-seven notifications were identified as IMNM of which 14 with pembrolizumab. The ROR was 17.59 (95% CI: 9.4-32.9).

conclusionThe diagnosis of IMNM does not always take into account recent criteria for the diagnosis of this pathology. This study highlights the existence of a signal, as well as the need for collaboration between oncologists and neurologists for these neurological pathologies.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsMuscular DiseasesAntibodies, Monoclonal, HumanizedHumansAntibodies, Monoclonal, HumanizedpembrolizumabDiagnosisImmune necrotizing myopathyPembrolizumabSafety

Identifiers

PMID34993569
OpenAlexW4205422679

What OpenQuestion holds

Textmetadata
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.