Lecanemab, Anti-amyloid monoclonal antibodies, Pharmacovigilance, Individual case safety reports, Disproportionality analysis, Case-by-case analysis, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571, Neurology. Diseases of the nervous system, RC346-429

Abstract The anti-amyloid monoclonal antibody lecanemab received the US accelerated approval for mild cognitive impairment or mild dementia stage of Alzheimer disease in January 2023, which was converted into traditional approval in June 2023. However, its regulatory assessment in Europe is still ongoing, and the European Commission has asked the Committee for Medicinal Products for Human Use of the European Medicines Agency to consider an update on the safety of lecanemab. Thus, timely post-marketing real-life studies are essential to clarify its long-term safety profile and to establish relevant place in therapy. In this regard, a recent study by Xing et al., analyzed individual case safety reports (ICSRs) collected in the Food and Drug Administration Adverse Event Reporting System (FAERS), a consolidated pharmacovigilance archive. In this Matters Arising article, we highlighted important methodological aspects that should not be overlooked by clinicians who are not fully familiar with this kind of study (the so-called disproportionality analysis through the case/non-case design), thus supporting enhanced awareness of stakeholders on interpretation, limitations and opportunities of FAERS data. To this end, we focused on the unexpected signal of pancreatic carcinoma raised by Xing et al., attempted to replicate the statistical findings and also provided a descriptive inspection of ICSRs: these are current rights and duties of modern pharmacovigilance to ensure evidence-based decision making.