| アブストラクト | 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. |
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| ジャーナル名 | BMJ open |
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| Pubmed追加日 | 2024/12/4 |
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| 投稿者 | L'Orphelin, Jean-Matthieu; Da Silva, Angelique; Cabon, Jean; Alexandre, Joachim; Dolladille, Charles |
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| 組織名 | Caen Normandy University Hospital, Caen, France;jean.matthieu.lorphelin@gmail.com.;University of Caen Normandy, Caen, France.;Departments of Pharmacology & Oncology, University of Caen Normandy, Caen,;France.;PICARO Cardio-Oncology Program, Department of Pharmacology, CHRU de Caen, Caen,;EA4650, Signalisation, Electrophysiologie et Imagerie des Lesions;d'Ischemie-reperfusion Myocardique, Universite de Caen Normandie, Caen, France.;Universite de Caen Normandie, Caen, France. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39627133/ |
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