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Author: Anoma Ranaweera, Medical Writer, Auckland, New Zealand. DermNet New Zealand Editor in Chief: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, August 2016. Copy editors: Gus Mitchell/Maria McGivern. October 2017.
Brodalumab (Siliq™; Valeant Pharmaceuticals, New Jersey, USA) is a human monoclonal IgG2 antibody that selectively binds to human interleukin-17 (IL-17) receptor and inhibits its interactions with a number of cytokines of the IL–17 family. Brodalumab targets the receptor for IL–17, which is a cytokine or messenger protein involved in inflammation resulting in psoriasis.
In February 2017, brodalumab received US Food and Drug Administration (FDA) approval to treat psoriasis in adult patients who have not responded to other treatments. In May 2017, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the granting of a marketing authorisation for brodalumab for the treatment of moderate–to–severe plaque psoriasis in adults who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected) or phototherapy (ultraviolet radiation treatment).
Chronic plaque psoriasis
The approval of brodalumab was based on three phase 3 trials:
Table 1. Clinical response at Week 12 (AMAGINE–1)
The most frequent adverse events (≥ 5% in any group) at Week 12 were:
Table 2. Common adverse events at Week 12 (AMAGINE-1)
There were four fatal adverse events through Week 52: these included:
Tables 3 & 4. Clinical response at week 12 — AMAGINE–2 and AMAGINE–3
Tables 5 & 6. Maintenance of clinical response to brodalumab at Week 52 — AMAGINE–2 and AMAGINE–3
If you are not based in New Zealand, we suggest you refer to your national drug approval agency for further information about medicines (eg, the Australian Therapeutic Goods Administration and the US Food and Drug Administration) or a national or state-approved formulary (eg, the New Zealand Formulary and New Zealand Formulary for Children and the British National Formulary and British National Formulary for Children).
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