The clinical spectrum and causal relationship assessment of checkpoint inhibitor‐associated autoimmune diabetes mellitus (CIADM): A retrospective observational study
Authors' conclusion
CIADM is a severe immune-related adverse event (irAE) characterized by abrupt onset, a high rate of DKA, and profound insulin deficiency, often in the absence of conventional islet autoantibodies. A definitive causal link exists between PD-1/PD-L1 inhibitors and CIADM. Our findings underscore the necessity for proactive glycemic monitoring in patients undergoing ICI therapy, especially in populations such as middle-aged males with cancers known to have specific demographic profiles (e.g., hepatocellular carcinoma). Importantly, the resumption of immunotherapy is feasible with careful management, highlighting the critical role of a multidisciplinary approach to optimize oncological and metabolic outcomes.
Study context
- Population
- Hospitalized patients receiving PD-1/PD-L1 inhibitor therapy, 2020–20247 with CIADM
- Participants
- 4,382 patients
- Outcome
- CIADM incidence and clinical spectrum
Main finding
As reported in the abstract
- Diagnosed with CIADM
- seven (0.16%)
- Median age of CIADM patients (range 44-62)
- 52 years
- Hepatocellular carcinoma as primary malignancy
- 3/7
- Median ICI cycles before CIADM (range 5-23)
- 8
- Diabetic ketoacidosis (DKA) at onset
- 86% (6/7)
- Undetectable fasting and postprandial C-peptide (severe β-cell dysfunction)
- all patients
- Islet autoantibody positive
- one patient
- Naranjo 'probable' to 'highly probable' causality
- all cases
- Lifelong insulin required
- all patients
Observational data: associations, not effects.
Further findings
Immunotherapy reinitiation after glycemic stabilization
- Successfully reinitiated without exacerbating hyperglycemia
- six patients
Original publication
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