Observational studyBMJ open2024
Immune checkpoint inhibitor rechallenge after immune-related adverse events: a retrospective study from VigiBase update in 2024 looking for emergent safety signals.
Observational study in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04696250 (Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy), which is not on this map. Cited by 4 papers.
What it found
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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.
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.
Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR)
Who cites it
4 citing papers in PubMed.
- Critical complications in cancer patients admitted to the ICU in the era of immunotherapy: recognition, differential diagnosis, and management.Frontiers in medicine · 2026Review
- Pembrolizumab-induced type-1 diabetes mellitus: clinical characteristics, therapeutic strategies, and prognosis from a retrospective analysis of 43 published cases.Frontiers in endocrinology · 2026Article
- Complete response and HBsAg clearance of advanced hepatocellular carcinoma associated with hepatitis B by DEB-TACE combined systematic therapy: a case report.Frontiers in immunology · 2025Article
- Resumption of Immune Checkpoint Inhibitor Therapy Following Immune-related Adverse Events.In vivo (Athens, Greece)Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesLimited information is available on the safety of a rechallenge with an immune checkpoint inhibitor (ICI) after occurrence of an immune-related adverse event (irAE). We aim to identify potential emergent safety signals.
designThis is an update of our observational pharmacovigilance cohort study.
settingWe exanimated individual case safety reports from the WHO database VigiBase.
participantsWe included all individual case safety reports with ICI and rechallenged ICI.
interventionsWe identified that incident irAE cases using the Medical Dictionary for Regulatory Activities V.26.1 related with at least one ICI administration were systematically collected until 1 March 2024. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the recurrence rate (expressed as a percentage with its 95% CI) of the initial irAE postrechallenge with the same ICI.
resultsWe identified 1016 irAEs cases from ICI rechallenges. Of these, 323 irAEs recurrences occurred (31.8%, 95% CI 28.1 to 34.0). The most common postrechallenge irAEs were nephritis (recurrence rate: 50%, 95% CI 25 to 75), skin irAEs (44%, 95% CI 31 to 58) and colitis (39%, 95% CI 33 to 44).
conclusionsIn this updated, largest cohort study on rechallenge (NCT04696250), we observed a 31.8% recurrence rate of the same irAE postrechallenge with the same ICI, building on our previous findings. TRIAL REGISTRATION NUMBER: NCT04696250.
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Registered trials
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 Socratic graph.