Ethics approval and informed consent were not necessary, as the postmarketing data presented here were noninterventional and were not collected as part of a clinical study.
RESULTS
PYs is the number of events per 45.63 PYs of exposure). Within the 4-year period, 22% of AEs were reported by HCPs and 78% were reported by patients.
Among the common AEs listed in the brodalumab package insert, arthralgia was reported the most during the 4-year pharmacovigilance monitoring (Table 1). Of 115 cases of arthralgia (2.52 events/100 PYs), 53 patients continued and 25 discontinued brodalumab; 37 actions were unknown. Of the 4 new cases of arthralgia since the 3-year report, 3 patients were temporarily off brodalumab when their joint pain recurred.
