Expert opinion on drug safety · 2024
Fulminant type 1 diabetes mellitus: a neglected but high-risk adverse event associated with immune checkpoint inhibitors.
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Meng Kelin, Fu Shengling, Huang Yaochen, Chen Wei, Zou Wenbin
Аннотация
BACKGROUND: Immune checkpoint inhibitor (ICI) therapy has revolutionized cancer treatment but is associated with fulminant type 1 diabetes mellitus (FT1DM). Our study aims to investigate the association between ICI therapy and FT1DM using the FDA Adverse Event Reporting System (FAERS) database.
METHODS: We conducted a retrospective analysis from the first quarter of 2004 to the first quarter of 2023. The disproportionality analysis incorporating the reporting odds ratio (ROR) and information component (IC) was performed to assess the magnitude of the adverse event signal between ICIs and FT1DM.
RESULTS: A total of 520 cases of FT1DM were identified in association with ICI therapy, representing 75.9% of all FT1DM cases reported in the FAERS database. Descriptive analyses revealed a predominance in males (60.2%) and the elderly (70.6%). The median time to onset was 69 days and 337 patients (64.81%) were hospitalized while 35 (6.73%) cases resulted in death. Disproportionality analysis showed a strong signal for FT1DM with ICI treatment (ROR 438.84) versus other drugs.
CONCLUSION: These findings provide compelling evidence linking ICI therapy to the development of FT1DM, underscoring the need for clinical vigilance and early intervention strategies to optimize patient outcomes while leveraging the remarkable therapeutic potential of cancer immunotherapy.
METHODS: We conducted a retrospective analysis from the first quarter of 2004 to the first quarter of 2023. The disproportionality analysis incorporating the reporting odds ratio (ROR) and information component (IC) was performed to assess the magnitude of the adverse event signal between ICIs and FT1DM.
RESULTS: A total of 520 cases of FT1DM were identified in association with ICI therapy, representing 75.9% of all FT1DM cases reported in the FAERS database. Descriptive analyses revealed a predominance in males (60.2%) and the elderly (70.6%). The median time to onset was 69 days and 337 patients (64.81%) were hospitalized while 35 (6.73%) cases resulted in death. Disproportionality analysis showed a strong signal for FT1DM with ICI treatment (ROR 438.84) versus other drugs.
CONCLUSION: These findings provide compelling evidence linking ICI therapy to the development of FT1DM, underscoring the need for clinical vigilance and early intervention strategies to optimize patient outcomes while leveraging the remarkable therapeutic potential of cancer immunotherapy.