Adverse Event Reporting with Immune Checkpoint Inhibitors in Older Patients: Age Subgroup Disproportionality Analysis in VigiBase

Noseda, Roberta; Bonaldo, Giulia; Motola, Domenico; Stathis, Anastasios; Ceschi, Alessandro

doi:10.3390/cancers13051131

Cited by 10 publications

(5 citation statements)

References 27 publications

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“…Indeed, the effect of age difference on irAEs is controversial, 1) as some previous studies have reported that elderly patients showed slightly higher incidences of irAEs (Baldini et al, 2020), 2) some indicated that age distribution differed in different profiles of irAEs (Paderi et al, 2021), and 3) some found that age was not associated with irAEs (Gomes et al, 2021;Noseda et al, 2021). To some extent, our results are consistent with the second finding.…”

Section: Discussionsupporting

confidence: 85%

Pancreatic Adverse Events Associated With Immune Checkpoint Inhibitors: A Large-Scale Pharmacovigilance Analysis

Zhang

Fang

et al. 2022

Front. Pharmacol.

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Backgrounds: Immune checkpoint inhibitors (ICIs) are considered cornerstones of oncology treatment with durable anti-tumor efficacy, but the increasing use of ICIs is associated with the risk of developing immune-related adverse events (irAEs). Although ICI-associated pancreatic adverse events (AEs) have been reported in patients treated with ICIs, the clinical features and spectrum of pancreatic AEs are still not well-defined. Therefore, this study aimed to identify the association between pancreatic AEs and ICIs treatments and to characterize the main features of ICI-related pancreatic injury (ICIPI) based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods: Data from the first quarter of 2015 to the first quarter of 2021 in the database were extracted to conduct a disproportionality analysis. The selection of AEs related to the pancreas relied on previous studies and preferred terms from the Medical Dictionary for Regulatory Activities. Two main disproportionality analyses—the reporting odds ratio (ROR) and information component (IC)—were used to evaluate potential associations between ICIs and pancreatic AEs. Results: In total, 2,364 cases of pancreatic AEs in response to ICIs were extracted from the FAERS database, of which, 647 were identified as ICI-associated pancreatitis and 1,293 were identified as ICI-associated diabetes mellitus. Generally, significant signals can be detected between pancreatic AEs and all ICIs treatments (ROR025 = 3.30, IC025 = 1.71). For monotherapy, the strongest signal associated with pancreatitis was reported for anti-PD-L1 (ROR025 = 1.75, IC025 = 0.76), whereas that with diabetes mellitus was reported for anti-PD-1 (ROR025 = 6.39, IC025 = 2.66). Compared with monotherapy, combination therapy showed stronger associations with both ICI-associated pancreatitis (ROR025 = 2.35, IC025 = 1.20 vs. ROR025 = 1.52, IC025 = 0.59) and ICI-associated diabetes mellitus (ROR025 = 9.53, IC025 = 3.23 vs. ROR025 = 5.63, IC025 = 2.48), but lower fatality proportion. Conclusions: ICIs were significantly associated with the over-reporting frequency of pancreatic AEs, in which combination therapy posed a higher reporting frequency. Therefore, patients should be informed of these potential toxicities before ICIs medications are administered.

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Section: Discussionsupporting

confidence: 85%

Pancreatic Adverse Events Associated With Immune Checkpoint Inhibitors: A Large-Scale Pharmacovigilance Analysis

Zhang

Fang

et al. 2022

Front. Pharmacol.

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“…It is important to highlight that we performed a disproportionality analysis with RORs restricted to the ICI drug class for assessing the reporting frequency of cardiac ICSRs. It should be noted that this is an approach used in pharmacovigilance to assess the reporting frequency of ICSRs within a drug class [ 14 , 23 , 24 ]. However, this type of analysis is not useful to assess a class effect on toxicity but other studies with different methodologies are needed on this front.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2021

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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. adrre ports. 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.Annamaria Mascolo and Cristina Scavone share first authorship.Roberto Alfano and Annalisa Capuano share lead authorship.

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“…VigiBase has contained approximately 30 million Individual Case Safety Reports (ICSRs) from 153 member countries. [15] Postmarketing data were sent to VigiBase, suggesting that a certain drug may be linked to suspected adverse drug reactions. [16] Speci cally, VigiBase gathers all ICSRs relevant to drugs or vaccines, all of which have been spontaneously reported from various sources in a structured form.…”

Section: Data Sourcementioning

confidence: 99%

Autoimmune disorders reported following COVID-19 vaccination: A disproportionality analysis using the WHO database

Kim,

Bea,

Choe

et al. 2024

Eur J Clin Pharmacol

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Purpose: Owing to autoimmune disorders (AIDs) and coronavirus disease vaccines sharing common biological mechanisms, identifying the risk of AIDs associated with COVID-19 vaccines remains a critical unmet need. We aimed to assess the potential safety signals for 16 AIDs and explore coreported adverse events (AEs) and drugs using the global database of the World Health Organization, VigiBase.Methods: We assessed the occurrence of 16 AIDs following COVID-19 vaccination through the Standardised MedDRA Queries group "Immune-mediated/Autoimmune Disorders" from MedDRA and performed a disproportionality analysis using reporting odds ratio (ROR) and information component (IC) with 95% con dence intervals (CIs).Results: We identi ed 25,219 AIDs associated with COVID-19 vaccines in VigiBase and detected four autoimmune safety signals following COVID-19 vaccination, including ankylosing spondylitis or psoriatic

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Adverse Event Reporting with Immune Checkpoint Inhibitors in Older Patients: Age Subgroup Disproportionality Analysis in VigiBase

Cited by 10 publications

References 27 publications

Pancreatic Adverse Events Associated With Immune Checkpoint Inhibitors: A Large-Scale Pharmacovigilance Analysis

Pancreatic Adverse Events Associated With Immune Checkpoint Inhibitors: A Large-Scale Pharmacovigilance Analysis

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

Autoimmune disorders reported following COVID-19 vaccination: A disproportionality analysis using the WHO database

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