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The Real-World Safety Profile of Immune Checkpoint Inhibitors in Melanoma: FAERS Pharmacovigilance Analysis
Yiwei Chen1, Xueyan Liang2, Xiaoyu Chen3
1Department of Pharmacy Guangxi Academy of Medical Sciences and the People's Hospital of Guangxi Zhuang Autonomous Region Nanning People's Republic of China.
Background And Aims:
Melanoma can be effectively treated with immune checkpoint inhibitors (ICIs), but information regarding the risks of treatment-related adverse events (trAEs), immune-related adverse events (irAEs), and real-world adverse events (AEs) is scarce.
Methods:
We searched PubMed, Embase, Medline, and Cochrane CENTRAL databases for randomized controlled trials (RCTs) comparing ICIs for melanoma therapy up to February 16, 2025. Bayesian network meta-analysis (NMA) was conducted, and odds ratios (ORs) with 95% credible intervals (95%CrI) were calculated. A pharmacovigilance analysis was performed using the Food and Drug Administration Adverse Event Reporting System (FAERS) database. ICI-associated AEs in patients with melanoma were obtained for the period from the first quarter (Q1) of 2004 to Q1 of 2023.
Results:
The NMA included 31 RCTs, comprising 11,937 patients with melanoma. Ipilimumab (Ipi), nivolumab (Nivo), and pembrolizumab (Pem) were ranked as having the lowest risk of any grade as well as grade 3-5 trAEs. Chemotherapy (Chemo) was associated with the lowest risk of any grade or grade 3-5 irAEs. Compared to other ICIs, Chemo, Ipi, and Ipi-Chemo were associated with the lowest risk of any irAEs. Based on the results of the FAERS pharmacovigilance analysis, we identified 5974 AEs in 4599 melanoma patients treated with ICIs. ICIs were associated with statistically significant indications involving 236 preferred terms (PTs). Thoroughly examined and pinpointed AEs were strongly correlated with ICIs. Pem treatment was associated with 166 significant PTs. Apart from malignant neoplasm progression and death, the most common PT was an immune-mediated adverse reaction.
Conclusion:
The results of this study indicated that ICI safety profiles vary. These findings provide comparative safety signals that may help inform AE monitoring and risk assessment in patients with melanoma receiving ICIs, but they should not be interpreted as definitive prescribing guidance.
Insights
Immune checkpoint inhibitors (ICIs) for melanoma have varying safety profiles. This study compared treatment-related adverse events (trAEs) and immune-related adverse events (irAEs) to guide monitoring and risk assessment in melanoma patients undergoing ICI therapy.
Area of Science:
- Oncology
- Immunology
- Pharmacovigilance
Background:
- Melanoma treatment effectively utilizes immune checkpoint inhibitors (ICIs).
- Limited data exists on treatment-related adverse events (trAEs), immune-related adverse events (irAEs), and real-world adverse events (AEs) associated with ICIs.
- Understanding ICI safety profiles is crucial for managing melanoma patients.
Purpose of the Study:
- To compare the safety profiles of different ICIs used in melanoma treatment.
- To identify specific adverse events (AEs) associated with various ICIs.
- To provide comparative safety signals for AE monitoring and risk assessment in melanoma patients receiving ICIs.
Main Methods:
- A Bayesian network meta-analysis (NMA) of 31 randomized controlled trials (RCTs) involving 11,937 melanoma patients.
- Pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS) database from 2004 to 2023.
- Calculation of odds ratios (ORs) with 95% credible intervals (95%CrI) for AE risk comparison.
Main Results:
- Ipilimumab (Ipi), nivolumab (Nivo), and pembrolizumab (Pem) showed the lowest risk for any grade and grade 3-5 trAEs.
- Chemotherapy (Chemo) demonstrated the lowest risk for any grade or grade 3-5 irAEs.
- FAERS analysis identified 5974 AEs in 4599 melanoma patients, with immune-mediated reactions being common, particularly with Pem.
Conclusions:
- ICI safety profiles differ significantly, impacting AE risk and monitoring strategies.
- Findings offer comparative safety insights for clinicians managing melanoma patients on ICIs.
- These results aid in risk assessment but should not replace clinical judgment for prescribing decisions.
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This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...