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Correction: Jiménez-Sánchez et al. Antioxidant Enzymes Genetic Variants Associated with Urticaria/Angioedema Induced by Cross-Reactive Hypersensitivity to Nonsteroidal Anti-Inflammatory Drugs. <i>Pharmaceuticals</i> 2026, <i>19</i>, 522.

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Correction: Zhao et al. Multifunctional Gel Films of Marine Polysaccharides Cross-Linked with Poly-Metal Ions for Wound Healing. <i>Pharmaceuticals</i> 2022, <i>15</i>, 750.

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Immune-Related Adverse Events Associated with Immune Checkpoint Inhibitors: A Scoping Review.

Costanza Tacchi1, Irma Convertino2,3, Guido Bocci1

  • 1Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, 56126 Pisa, Italy.

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Summary
This summary is machine-generated.

Immune checkpoint inhibitors (ICIs) can cause various immune-related adverse events (irAEs) across different cancers. This review identifies patterns and knowledge gaps in irAE management using real-world data.

Keywords:
European Medicines AgencyFood and Drug Administrationadministrative healthcare databasesimmune checkpoint inhibitorsimmune-related adverse eventsspontaneous reporting systems

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Area of Science:

  • Oncology
  • Immunology
  • Pharmacovigilance
  • Real-world evidence

Background:

  • Immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICIs) exhibit significant heterogeneity in real-world data.
  • Identifying patterns, knowledge gaps, and research priorities for irAEs is crucial for improving patient outcomes.

Purpose of the Study:

  • To assess labeled irAEs for ICIs in lung cancer, melanoma, breast cancer, and colon cancer.
  • To evaluate the incidence, clinical characteristics, management, and outcomes of irAEs in real-world studies.

Main Methods:

  • Assessed regulatory agency data (FDA, EMA) for labeled irAEs associated with ICIs.
  • Conducted a PRISMA-guided scoping review of observational studies and target trial emulation studies from PubMed.
  • Included studies using administrative healthcare databases (AHDs) and spontaneous reporting systems (SRSs) for irAE data retrieval.

Main Results:

  • ICI combination therapy was associated with increased irAE occurrence and revealed inter-agency differences.
  • 49 observational studies were included; pembrolizumab and nivolumab were most evaluated.
  • Most reported irAEs included lower respiratory tract disorders (SRSs) and epidermal/dermal conditions (AHDs).
  • Significant data gaps were identified regarding survival analysis, dechallenge/rechallenge, concomitant therapies, comorbidities, onset time, and duration of irAEs.

Conclusions:

  • This scoping review underscores the complex, multi-organ nature of irAEs induced by ICIs.
  • There is a critical need for tailored monitoring and management strategies for irAEs, integrating both regulatory and real-world evidence.