Immune-related adverse events in immunotherapy: Challenges in diagnosis, monitoring, and management

Mohd Aftab Siddiqui1, Afreen Usmani2, Mohd Nazam Ansari3

  • 1Faculty of Pharmacy, Integral University, Lucknow, U.P., India.

Toxicology Reports
|September 17, 2025
PubMed

This article provides a comprehensive overview of safety and monitoring guidelines in immunotherapy, a rapidly advancing field in cancer and autoimmune treatment. Immunotherapy, which harnesses the body's immune system to combat diseases, has shown remarkable promise but presents unique safety challenges requiring rigorous oversight. The article examines various immunotherapies, including immune checkpoint inhibitors, monoclonal antibodies, and cytokine therapies, highlighting potential adverse effects and the critical need for careful monitoring. It emphasizes pre-treatment assessments, risk stratification, and genetic and biomarker screening to identify high-risk patients. Detailed monitoring protocols, including laboratory tests, imaging, and clinical evaluations, are discussed to detect immune-related adverse events (irAEs) early. Strategies for managing both acute and chronic toxicities, such as dose adjustments and treatment interruptions, are outlined to ensure timely intervention and individualized care. The article also underscores the importance of patient education, compliance, and supportive care, emphasizing a multidisciplinary approach. Through this detailed review, healthcare professionals gain practical guidelines to optimize the safe and effective use of immunotherapies in clinical settings.

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