Key messages
- Brodalumab è approvato per il trattamento della psoriasi in placche moderata-severa.
- Il presente studio ha valutato il profilo di sicurezza di brodalumab analizzando i dati aggregati sulla sicurezza di 5 trial di fase II/III relativi a un dosaggio di 140 mg o 210 mg.
- Brodalumab non si è associato a un rischio aumentato di neoplasie, eventi avversi cardiaci maggiori, ideazione o comportamento suicidario o eventi fatali.
- Globalmente, brodalumab ha mostrato un profilo di sicurezza accettabile nel trattamento a breve e lungo termine.
Abstract
Brodalumab is approved for treatment of moderate-to-severe plaque psoriasis. Here, we assess the safety profile of brodalumab using pooled safety data from 5 phase II/III trials of brodalumab 140 mg or 210 mg. In total, 4,464 patients received brodalumab, representing 8,891.6 patient-years of exposure. During the placebo-controlled 12-week induction period, rates of serious adverse events per 100 patient-years were 10.8 and 9.6 (brodalumab 140 mg and 210 mg, respectively) vs 4.3 and 6.5 (ustekinumab and placebo, respectively); infections were the most frequent serious adverse event. Rates of serious adverse events during the comparator-controlled 52-week period were 14.4, 10.2 and 8.3 per 100 patient-years for brodalumab 210 mg, brodalumab 140 mg, and ustekinumab, respectively. Brodalumab was not associated with increased risks of malignancy, major adverse cardiac events, suicidal ideation and behaviour, or fatal events. Overall, brodalumab demonstrated an acceptable safety profile in short- and long-term treatment.