Laboratory Medicine in Immune Checkpoint Inhibitor-Induced Autoimmune Disorders: Baseline Assessment, Diagnostic Algorithms, Monitoring, and Predictive Biomarkers

Immune checkpoint inhibitors (ICIs) have substantially improved clinical outcomes across multiple malignancies, but they can disrupt self-tolerance and induce immune-related adverse events resembling autoimmune disorders. In many cases, laboratory abnormalities precede overt clinical manifestations, placing laboratory medicine at the center of baseline evaluation, early recognition, diagnostic confirmation, longitudinal monitoring, and treatment follow-up. This review provides a laboratory-focused overview of ICI-induced autoimmune disorders, focusing on baseline laboratory assessment, monitoring strategies during therapy, organ-specific diagnostic algorithms, ICI-specific toxicity patterns, and candidate predictive biomarkers. Particular attention is paid to endocrine, hepatic, metabolic, cardiac, rheumatologic, and neurologic toxicities and to pre-analytical and analytical issues that can confound interpretation. The potential contribution of digital tools and artificial intelligence to accelerating laboratory-based detection is also discussed. Standardized laboratory pathways integrating baseline testing, reflex and confirmatory algorithms, trend-based surveillance, and multidisciplinary interpretation can improve safety and support personalized decisions regarding immunotherapy continuation and management.

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Publication Details

Journal
Annals of Laboratory Medicine
Published
2026-08-18
DOI
https://doi.org/10.3343/alm.2025.0733
Primary Topic
Cancer Immunotherapy and Biomarkers
Type
article
Field-Weighted Citation Impact
0.00
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article

Laboratory Medicine in Immune Checkpoint Inhibitor-Induced Autoimmune Disorders: Baseline Assessment, Diagnostic Algorithms, Monitoring, and Predictive Biomarkers

Roberto Verna, Antonino Mazzone, Cecilia Matteoli
Annals of Laboratory Medicine
Cancer Immunotherapy and Biomarkers
article

Laboratory Medicine in Immune Checkpoint Inhibitor-Induced Autoimmune Disorders: Baseline Assessment, Diagnostic Algorithms, Monitoring, and Predictive Biomarkers

Roberto Verna, Antonino Mazzone, Cecilia Matteoli
article en

Abstract

Immune checkpoint inhibitors (ICIs) have substantially improved clinical outcomes across multiple malignancies, but they can disrupt self-tolerance and induce immune-related adverse events resembling autoimmune disorders. In many cases, laboratory abnormalities precede overt clinical manifestations, placing laboratory medicine at the center of baseline evaluation, early recognition, diagnostic confirmation, longitudinal monitoring, and treatment follow-up. This review provides a laboratory-focused overview of ICI-induced autoimmune disorders, focusing on baseline laboratory assessment, monitoring strategies during therapy, organ-specific diagnostic algorithms, ICI-specific toxicity patterns, and candidate predictive biomarkers. Particular attention is paid to endocrine, hepatic, metabolic, cardiac, rheumatologic, and neurologic toxicities and to pre-analytical and analytical issues that can confound interpretation. The potential contribution of digital tools and artificial intelligence to accelerating laboratory-based detection is also discussed. Standardized laboratory pathways integrating baseline testing, reflex and confirmatory algorithms, trend-based surveillance, and multidisciplinary interpretation can improve safety and support personalized decisions regarding immunotherapy continuation and management.

Annals of Laboratory Medicine
Marconi University (IT), World Health Organization - Italy (IT), Azienda Ospedaliera Ospedale Civile di Legnano (IT), University of Florence (IT)
Good health and well-being
Openalex Percentile: Top 12%
Cancer Immunotherapy and Biomarkers
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