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Abstract
Objectives Limited 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.
Design This is an update of our observational pharmacovigilance cohort study.
Setting We exanimated individual case safety reports from the WHO database VigiBase.
Participants We included all individual case safety reports with ICI and rechallenged ICI.
Interventions We 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.
Results We 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).
Conclusions In 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.
- Adult oncology
- IMMUNOLOGY
- Adverse events
Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. Data are available on request to CD, corresponding author.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. Data are available on request to CD, corresponding author.
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Footnotes
J-ML and ADS contributed equally.
Contributors JMLO: writing, data curation, revision. ADS: writing, data curation. JC: writing. JA: writing, design of the study. CD: guarantor, statistics, writing, design of the study.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests JA reports honoraria for presentations and consulting fees from Biotronik, Bioserenity, Amgen, BMS, Pfizer, Boerhinger, Bayer, Astra Zeneca, Janssen, Servier and Novartis, outside of the submitted work. CD reports honoraria for presentations and consulting fees from Bioserenity and Pfizer, outside of the submitted work. JMLO reports honoraria for presentations and consulting fees from BMS, MSD, Novartis, Laboratoires Gilbert and Pierre Fabre oncology, outside of the submitted work. ADS reports honoraria for presentations and consulting fees from Leopharma, outside of the submitted work. The remaining authors have nothing to disclose.
Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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