Abstract
Brodalumab is approved for treatment of moderateto-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.
| Original language | English |
|---|---|
| Article number | adv00683 |
| Journal | Acta Dermato-Venereologica |
| Volume | 102 |
| ISSN | 0001-5555 |
| DOIs | |
| Publication status | Published - 2022 |
Funding
The phase II, phase II open-label extension, AMAGINE-1, AMAGINE-2 and AMAGINE-3 trials were sponsored by Amgen and AstraZeneca. This analysis was performed by LEO Pharma. Medical writing support provided by Siz Madsen of Larix A/S (Herlev, Denmark), Johanna Barry, PhD, of Adelphi Communications Ltd (Bollington, UK), and Clair Geary, PhD, of Alphabet Health (New York, NY, USA), was funded by LEO Pharma A/S in accordance with Good Publication Practice (GPP3) guidelines. All authors participated in interpreting the results and writing the manuscript and approved the final version for submission. AstraZeneca was not involved in the decision to publish these analyses and did not participate in the preparation of this manuscript. The phase II, phase II open-label extension, AMAGINE-1, AMAGINE-2, and AMAGINE-3 trials were sponsored by Amgen and AstraZeneca.
Research Areas and Centers
- Academic Focus: Center for Infection and Inflammation Research (ZIEL)
- Centers: Center for Research on Inflammation of the Skin (CRIS)
DFG Research Classification Scheme
- 2.22-19 Dermatology
