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Myocarditis Associated with Immune Checkpoint Inhibitors: An Expert Consensus on Data Gaps and a Call to Action.

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Immune checkpoint inhibitors (ICIs) can cause myocarditis, a serious side effect. This report details a workshop focused on increasing awareness, risk identification, and early diagnosis of ICI-associated myocarditis.

Keywords:
Immune checkpoint inhibitorImmune‐related adverse eventsMyocarditisPD‐1/PD‐L1 inhibitorProject Data Sphere

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Area of Science:

  • Oncology
  • Immunology
  • Cardiology

Background:

  • Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment.
  • Immune-related adverse events (irAEs) are known side effects of ICIs.
  • Myocarditis is an uncommon but severe irAE associated with ICIs.

Purpose of the Study:

  • To evaluate current knowledge on ICI-associated myocarditis.
  • To determine methods for data collection and sharing on ICI-associated myocarditis.
  • To establish task forces to address knowledge gaps regarding ICI-associated myocarditis.

Main Methods:

  • A workshop convened by the "Checkpoint Inhibitor Safety Working Group" on December 15, 2017.
  • Multidisciplinary collaboration involving academic, industry, and regulatory partners.
  • Review and synthesis of existing information on ICI-associated myocarditis.

Main Results:

  • ICI-associated myocarditis is a serious, potentially life-threatening adverse event.
  • Challenges in assessment and characterization due to low incidence and varied presentations.
  • The need for coordinated efforts to improve awareness, risk identification, diagnosis, and treatment.

Conclusions:

  • Increased awareness and early diagnosis of ICI-associated myocarditis are crucial.
  • Standardized data collection and sharing are necessary to close knowledge gaps.
  • Multidisciplinary collaboration is essential for managing this adverse event in cancer patients.