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Thrombotic microangiopathy associated with anticancer and immune system targeting drugs: New insights from real-world

Bérenger Largeau1, Benjamin Thoreau2, Steven Grangé3,4

  • 1Service de Pharmacosurveillance, Centre Régional de Pharmacovigilance, Hôpital Bretonneau, CHU Tours, Tours, France.

Journal of Internal Medicine
|August 4, 2023
PubMed
Abstract

Insights

Immuno-oncology drugs are increasingly linked to thrombotic microangiopathy syndromes (TMA). This study analyzed global safety reports, identifying new drug risks and an evolving pattern of TMA cases associated with these advanced cancer therapies.

Area of Science:

  • Pharmacovigilance
  • Oncology
  • Hematology

Background:

  • Immuno-oncology and anticancer drugs are vital but may cause thrombotic microangiopathy syndromes (TMA).
  • Real-world data is crucial for understanding drug-associated TMA risks.
  • The study focuses on identifying specific drugs linked to TMA and tracking reporting trends.

Purpose of the Study:

  • To identify immune system targeting/anticancer drugs associated with TMA reporting.
  • To analyze the temporal evolution of TMA reporting concerning these drugs.
  • To detect potential new safety concerns for TMA among these drug classes.

Main Methods:

  • A global disproportionality analysis of individual case safety reports (ICSRs) from VigiBase (1968-2022).
  • Inclusion of 6946 suspected drug-induced TMA cases from 55 countries.
  • Assessment of drug overreporting and trends in TMA case reporting.

Main Results:

  • 72 immune system targeting/anticancer drugs showed significant overreporting for TMA; 17 are potential new safety concerns.
  • While TMA reporting rates per million ICSRs remained stable, absolute case numbers increased in the last decade.
  • The proportion of TMA cases involving these drugs rose from 47.3% (1992-2001) to 80.7% (2012-2021).

Conclusions:

  • Newer immune system targeting/anticancer drugs are increasingly associated with TMA.
  • Confirmatory studies are needed to validate these potential new drug-TMA associations.
  • The rise in drug-associated TMA is primarily driven by innovative anticancer therapies.
Keywords:
hemolytic uremic syndromemonoclonal antibodypharmacovigilancethrombotic microangiopathy syndromethrombotic thrombocytopenic purpura

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