A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for lecanemab DOI Creative Commons
Linlin Yan, Linhai Zhang, Zucai Xu

и другие.

Frontiers in Pharmacology, Год журнала: 2025, Номер 16

Опубликована: Апрель 2, 2025

Lecanemab is a humanized murine IgG1 antibody. Recent Phase 3 clinical trials have demonstrated its ability to reduce brain amyloid-β (Aβ) load and slow cognitive decline in patients with early Alzheimer's disease (AD). However, since approval, reports on adverse effects (AEs) associated lecanemab been limited. To better understand the AEs related provide guidance for future use, we analyzed lecanemab-associated using data from United States Food Drug Administration (FDA) Adverse Event Reporting System (FAERS). We extracted all FAERS database period first quarter of 2023 third 2024. Using Odds Ratio (ROR), Proportional (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), Multi-item Gamma Poisson Shrinker (MGPS) algorithms, conducted comprehensive analysis lecanemab-related AEs, restricting role code primary suspect (PS). A total 811 used AD 506 Non-AD were included. The preferred terms (PTs) identified as positive across four algorithms included headache, Amyloid Related Imaging Abnormalities-oedema/effusion (ARIA-E), chills, Abnormalities-haemosiderosis/microhaemorrhage (ARIA-H), fatigue, infusion-related reaction, nausea, pyrexia, pain, influenza like illness, so on. Among these, ARIA-E, ARIA-H, oedema status epilepticus Important Medical Events (IMEs) patients, oedema, cerebral haemorrhage, microhaemorrhage, subdural haematoma, ischaemic stroke, infarction IMEs patients. At system organ class (SOC) level, highest signal detection was observed nervous disorders among [ROR AD: 2.42 (2.2-2.65); ROR Non-AD: 6.97 (6.12-7.95)]. median time occurrence these 44 days after administration 30 This study utilized evaluate non-AD along their temporal patterns post-marketing authorization, thereby establishing foundation subsequent pharmacovigilance. biweekly 10 mg/kg optimal therapeutic dosage. ARIA emerged frequent treatment-related APOEɛ4 carriers demonstrating heightened susceptibility. necessitates serial MRI surveillance during treatment, aimed not only at but also vigilant monitoring including microhaemorrhages, edema, infarction. While predominantly exhibited non-specific manifestations, cohorts showed elevated risks stroke-related complications. Consequently, dynamic neurological deficit indispensable populations receiving mitigate outcomes. Finally, reassessment anticoagulant or antiplatelet therapy indications warranted both hemorrhagic risks.

Язык: Английский

A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for lecanemab DOI Creative Commons
Linlin Yan, Linhai Zhang, Zucai Xu

и другие.

Frontiers in Pharmacology, Год журнала: 2025, Номер 16

Опубликована: Апрель 2, 2025

Lecanemab is a humanized murine IgG1 antibody. Recent Phase 3 clinical trials have demonstrated its ability to reduce brain amyloid-β (Aβ) load and slow cognitive decline in patients with early Alzheimer's disease (AD). However, since approval, reports on adverse effects (AEs) associated lecanemab been limited. To better understand the AEs related provide guidance for future use, we analyzed lecanemab-associated using data from United States Food Drug Administration (FDA) Adverse Event Reporting System (FAERS). We extracted all FAERS database period first quarter of 2023 third 2024. Using Odds Ratio (ROR), Proportional (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), Multi-item Gamma Poisson Shrinker (MGPS) algorithms, conducted comprehensive analysis lecanemab-related AEs, restricting role code primary suspect (PS). A total 811 used AD 506 Non-AD were included. The preferred terms (PTs) identified as positive across four algorithms included headache, Amyloid Related Imaging Abnormalities-oedema/effusion (ARIA-E), chills, Abnormalities-haemosiderosis/microhaemorrhage (ARIA-H), fatigue, infusion-related reaction, nausea, pyrexia, pain, influenza like illness, so on. Among these, ARIA-E, ARIA-H, oedema status epilepticus Important Medical Events (IMEs) patients, oedema, cerebral haemorrhage, microhaemorrhage, subdural haematoma, ischaemic stroke, infarction IMEs patients. At system organ class (SOC) level, highest signal detection was observed nervous disorders among [ROR AD: 2.42 (2.2-2.65); ROR Non-AD: 6.97 (6.12-7.95)]. median time occurrence these 44 days after administration 30 This study utilized evaluate non-AD along their temporal patterns post-marketing authorization, thereby establishing foundation subsequent pharmacovigilance. biweekly 10 mg/kg optimal therapeutic dosage. ARIA emerged frequent treatment-related APOEɛ4 carriers demonstrating heightened susceptibility. necessitates serial MRI surveillance during treatment, aimed not only at but also vigilant monitoring including microhaemorrhages, edema, infarction. While predominantly exhibited non-specific manifestations, cohorts showed elevated risks stroke-related complications. Consequently, dynamic neurological deficit indispensable populations receiving mitigate outcomes. Finally, reassessment anticoagulant or antiplatelet therapy indications warranted both hemorrhagic risks.

Язык: Английский

Процитировано

0