Brodalumab
Brodalumab (Siliq, Lumicef, Kyntheum, AMG-827) is a human IgG2 antibody, targeting the interleukin-17 receptor (IL-17RA). It can block the inflammatory signal of IL-17A through IL-17RA, and promote the inflammatory cytokines IL-17F and IL-17C. Brodalumab was first approved in Japan on July 4, 2016 for Lumicef, which includes erythrodermic psoriasis, pustular psoriasis, psoriatic arthritis and psoriasis vulgaris. In February 2017 and July 2017, Brodalumab was approved in the United States and Europe, respectively, for the treatment of moderate to severe plaque psoriasis in adults who do not respond to systemic therapy or light therapy (UV therapy). Safety and efficacy of Brodalumab was studied in three placebo-controlled phase III clinical trials, amagine-1 (NCT01708590), Amagine-2 (NCT01708603) and Amagine-3 (NCT01708603), involving a total of 4,373 patients. The primary end point was the proportion of patients with psoriasis at week 12 who improved by more than 75% in area with severity (PASI75) and whose physician's static overall assessment (sPGA) score (0/1) decreased by at least 2 points from baseline. Amagine-1 results showed that 83 per cent of Brodalumab 210mg to PASI75, 60 per cent of the 140mg group and 3 per cent of the placebo group. The sPGA scores were also higher than the placebo group at 76%, 54% and 1%, respectively. Amagine-2 and Amagine-3 test data showed that the improvement of clinical symptoms of moderate and severe psoriasis was significantly better than that of placebo group. In amagine-2, the PASI compliance rate was 86% in 210mg group, 67% in 140mg group, and 8% in placebo group, 86% in Amagine-3, 69% and 6% in amagine-3, respectively. The sPGA compliance rate was also higher in the treatment group, 79% in 210mg amagine-2, 58% in 140mg group, and 4% in placebo group. In Amagine-3, 80%, 60% and 4%, respectively.
