Iñigo Les Bujanda
Specialist physician in the Internal Medicine Department at the Autoimmune Diseases Unit of the Internal Medicine Service at the University Hospital of Navarra and principal investigator of the Inflammatory and Immune-Mediated Diseases Group at the Navarrabiomed-Public University of Navarra research centre, Institute of Health Research of Navarra
This recent study published in PNAS analyzed severe adverse effects related to immune checkpoint inhibitors (ICIs), which are therapies with great promise for cancer treatment. With data from over 290,000 cases of patients treated with ICIs from global pharmacovigilance databases, the researchers applied advanced statistical methods to identify 73 types of organ-specific adverse events with significantly high mortality rates, termed “ICI-related high-mortality AEs”. The most significant ones include liver failure, respiratory failure, and septic shock. This approach, based on robust data and validated methods, also identified emergent complications not reported previously, such as gastrointestinal necrosis and portal vein thrombosis, which represents an important advance in the knowledge about the safety of these drugs.
The study aligns with previous research that explored the adverse effects of ICIs, but it provides a novel perspective through the analysis of the relationship between these events and mortality rates. However, the authors of the article point out significant limitations in their own work, such as the lack of information about the severity and medical management of the adverse events, the treatment doses, and the specific causes of the reported deaths. Furthermore, the data lack information about patient ethnicity, which could limit the generalization of the results to different populations and clinical scenarios.
In the context of Spain, where ICIs experience increased use in cancer treatment, this study underlines the importance of proactive surveillance strategies to identify and manage severe adverse events. The recommendation for healthcare professionals is to perform a more exhaustive follow-up of patients treated with ICIs, especially those with a higher risk of severe complications, like liver or respiratory failure. Additionally, the results could serve as a basis to establish formal contraindications for patients with a high risk of fatal adverse events, which would optimize the safety and efficacy of these therapies in clinical practice.