Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance

Annamaria Mascolo (), Cristina Scavone, Carmen Ferrajolo, Concetta Rafaniello, Romano Danesi, Marzia Re, Antonio Russo, Enrico Coscioni, Francesco Rossi, Roberto Alfano and Annalisa Capuano
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Annamaria Mascolo: Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology
Cristina Scavone: Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology
Carmen Ferrajolo: Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology
Concetta Rafaniello: Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology
Romano Danesi: University Hospital of Pisa
Marzia Re: University Hospital of Pisa
Antonio Russo: A.O.U.P. “P. Giaccone”, University Hospital Palermo
Enrico Coscioni: AGENAS-Agenzia Nazionale per i Servizi Sanitari Regionali
Francesco Rossi: Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology
Roberto Alfano: Azienda Ospedaliera Universitaria, University of Campania “Luigi Vanvitelli”
Annalisa Capuano: Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology

Drug Safety, 2021, vol. 44, issue 9, No 5, 957-971

Abstract: Abstract Introduction Immune checkpoint inhibitors (ICIs) are widely used in the treatment of many cancers as they improve clinical outcomes. However, ICIs have also been associated with the development of immune-related adverse drug reactions (ADRs). Among immune-related ADRs, cardiac immune-related ADRs are rare, but also associated with high mortality rates. Objective The objective of this study was to evaluate the occurrence of cardiac ADRs reported with ICIs in the European spontaneous reporting system. Methods We retrieved individual case safety reports on ICI-induced cardiac ADRs from the website of suspected ADR ( www.adrreports.eu ) of the European pharmacovigilance database (Eudravigilance). Data were retrieved from the date of marketing authorization of each ICI (ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, and cemiplimab) to 14 March, 2020. The reporting odds ratio and its 95% confidence interval were computed to assess the reporting frequency of cardiac ADRs for each ICI compared to all other ICIs. Results A total of 2478 individual case safety reports with at least one ICI as the suspected drug were retrieved from Eudravigilance, of which 249 (10%) reported more than one ICI. The three most reported ICIs were nivolumab (43.2%), pembrolizumab (32.5%), and the association of nivolumab/ipilimumab (9.4%). A total of 3388 cardiac ADRs were identified. Cardiac ADRs were serious (99.4%) and had a fatal outcome (30.1%). The most reported cardiac events were myocarditis, cardiac failure, atrial fibrillation, pericardial effusion, and myocardial infarction. Nivolumab was reported with a small increased reporting frequency of individual case safety reports with cardiac ADRs compared to all other ICIs (reporting odds ratio 1.09, 95% confidence interval 1.01–1.18). Conclusions Immune checkpoint inhibitor-induced cardiac ADRs were serious and had unfavorable outcomes. In our study, nivolumab was the only ICI with a small increased reporting frequency of individual case safety reports with cardiac ADRs compared to all other ICIs. In this regard, further head-to-head studies are needed.

Date: 2021
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DOI: 10.1007/s40264-021-01086-8

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