TY - JOUR

T1 - New Insight on the Safety of Erenumab

T2 - An Analysis of Spontaneous Reports of Adverse Events Recorded in the US Food and Drug Administration Adverse Event Reporting System Database

AU - Sessa, Maurizio

AU - Andersen, Morten

PY - 2021

Y1 - 2021

N2 - Aim The aim of this article was to provide an overview of adverse events reported for erenumab in post-marketing through the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and perform a disproportionality analysis with other drugs used for acute or preventative treatment of migraine as controls. Methods FAERS was screened from the first quarter of 2018 to the second quarter of 2020 (latest data update 30 June 2020). Clinical and demographic characteristics of cases were described along with the seriousness and outcome of adverse events. Disproportionality analyses were performed using the reporting odds ratio (ROR). Results In total, 23,312 cases were reported during the study period, 67.0% by consumers. Cases in the age range 18-64 years (10,922 cases; 45.8%), in female sex (15,099 cases; 64.8%), and with adverse events that were classified as non-serious (19,626 cases; 84.2%) were the most prevalent in the database. After the exclusion of duplicates, 146 fatal cases were identified. A total of 1303 unlabeled adverse events were reported, of which 49 had statistically significant disproportionality of reporting in comparison with other drugs used for acute or preventative treatment of migraine. Identified disproportionality signals included alopecia, depression, anxiety, myocardial infarction, increased heart rate, pulmonary embolism, weight alteration, insomnia, tinnitus, and influenza-like symptoms. Injection-site reactions (labeled events) were co-reported with errors in administration procedures. Conclusion Adverse events reported during the first 2 years of post-marketing surveillance were mostly non-serious and with a favorable prognosis. However, new safety aspects emerged for which further studies are needed to confirm the associations, prioritizing unlabeled events with consistent disproportionality signals (e.g., emerging in at least 4 out of 6 analyses).

AB - Aim The aim of this article was to provide an overview of adverse events reported for erenumab in post-marketing through the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and perform a disproportionality analysis with other drugs used for acute or preventative treatment of migraine as controls. Methods FAERS was screened from the first quarter of 2018 to the second quarter of 2020 (latest data update 30 June 2020). Clinical and demographic characteristics of cases were described along with the seriousness and outcome of adverse events. Disproportionality analyses were performed using the reporting odds ratio (ROR). Results In total, 23,312 cases were reported during the study period, 67.0% by consumers. Cases in the age range 18-64 years (10,922 cases; 45.8%), in female sex (15,099 cases; 64.8%), and with adverse events that were classified as non-serious (19,626 cases; 84.2%) were the most prevalent in the database. After the exclusion of duplicates, 146 fatal cases were identified. A total of 1303 unlabeled adverse events were reported, of which 49 had statistically significant disproportionality of reporting in comparison with other drugs used for acute or preventative treatment of migraine. Identified disproportionality signals included alopecia, depression, anxiety, myocardial infarction, increased heart rate, pulmonary embolism, weight alteration, insomnia, tinnitus, and influenza-like symptoms. Injection-site reactions (labeled events) were co-reported with errors in administration procedures. Conclusion Adverse events reported during the first 2 years of post-marketing surveillance were mostly non-serious and with a favorable prognosis. However, new safety aspects emerged for which further studies are needed to confirm the associations, prioritizing unlabeled events with consistent disproportionality signals (e.g., emerging in at least 4 out of 6 analyses).

U2 - 10.1007/s40259-021-00469-8

DO - 10.1007/s40259-021-00469-8

M3 - Journal article

C2 - 33609278

VL - 35

SP - 215

EP - 227

JO - BioDrugs

JF - BioDrugs

SN - 1173-8804

IS - 2

ER -