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Cardiovascular Adverse Events Associated with Tumor Necrosis Factor-Alpha Inhibitors: A Real-World Pharmacovigilance
Junlong Ma1,2, Jiangfan Cai2, Heng Chen3
1Center of Clinical Pharmacology, Th ird Xiangya Hospital, Central South University.
Insights
Adalimumab, but not other tumor necrosis factor-α inhibitors, showed a risk for thrombotic cardiovascular adverse events in a pharmacovigilance study. Further research is needed to confirm these findings for TNF-α therapies.
Area of Science:
- Pharmacovigilance and Drug Safety
- Immunology and Rheumatology
- Cardiovascular Medicine
Background:
- Limited and conflicting evidence exists on the cardiovascular risks associated with tumor necrosis factor-α (TNF-α) inhibitors.
- Understanding these associations is crucial for patient safety in treating inflammatory conditions.
Purpose of the Study:
- To investigate the association between specific TNF-α inhibitors and cardiovascular adverse events (AEs).
- To identify if any particular TNF-α inhibitor poses a higher risk for thrombotic cardiovascular events.
Main Methods:
- A retrospective pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database.
- Disproportionality analysis (Reporting Odds Ratio - ROR) was applied to cardiovascular AEs linked to adalimumab, infliximab, etanercept, golimumab, and certolizumab.
- Adjusted ROR and subgroup analyses were performed to control for confounders.
Main Results:
- Out of 9,817 cardiovascular reports, only adalimumab showed a significant association with myocardial infarction (ROR=1.58) and arterial thrombosis (ROR=1.54).
- No significant risk association was found for the other four TNF-α inhibitors.
- Adalimumab remained significantly associated with cardiovascular events, particularly in psoriasis patients (adjusted ROR=2.16).
Conclusions:
- Adalimumab was identified as the sole TNF-α inhibitor linked to an increased risk of thrombotic cardiovascular AEs.
- The other evaluated TNF-α inhibitors did not demonstrate a similar risk.
- Prospective studies are recommended to validate these pharmacovigilance findings due to inherent study limitations.
Aim:
Evidence regarding the association between various tumor necrosis factor-α (TNF-α) inhibitors and cardiovascular adverse events (AEs) is both limited and contradictory.
Methods:
A retrospective pharmacovigilance study was conducted using the FDA Adverse Event Reporting System (FAERS) database. Cardiovascular AEs associated with TNF-α inhibitors (adalimumab, infliximab, etanercept, golimumab, and certolizumab) were evaluated using a disproportionality analysis. To reduce potential confounders, adjusted ROR and subgroup analyses were performed.
Results:
After excluding duplicates, 9,817 cardiovascular reports were associated with the five TNF-α inhibitors. Only adalimumab had positive signals for myocardial infarction (ROR=1.58, 95%CI=1.51-1.64) and arterial thrombosis (ROR=1.54, 95%CI=1.49-1.58). The remaining four TNF-α inhibitors did not show a risk association with any type of cardiovascular event. Further analyses of specific indication subgroups and after adjusting for any confounding factors demonstrated that adalimumab was still significantly associated with cardiovascular events, especially in patients with psoriasis (adjusted ROR=2.16, 95%CI=1.95-2.39).
Conclusions:
This study revealed that adalimumab was the only TNF-α inhibitor associated with an elevated risk of thrombotic cardiovascular AEs, whereas the other four TNF-α inhibitors did not show any risk effect. However, given the limitations of such pharmacovigilance studies, it is necessary to validate these findings in prospective studies in the future.
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