Molecular Profile of Interleukin-17RA Blockade by Brodalumab in Japanese Patients with Psoriasis: Results from the ESPRTI study

Brodalumab, an anti-interleukin-17 receptor antibody, is presumed to be effective in psoriasis due to its action on the IL-17 pathway. This study is an analysis of an exploratory intervention study (ESPRIT) conducted in Japanese patients with moderate to severe plaque psoriasis. The efficacy of brodalumab was analyzed by clinical changes and modulation of skin inflammation by changes in gene expression in the skin and protein expression in blood samples. Overall design: The study was conducted at five sites in Japan from March 2020 to March 2022. Eligible patients were at least 18 years of age at the time of consent and had moderate to severe plaque psoriasis, psoriasis skin severity (PASI) score >10 or body surface area (BSA) >10%. Healthy volunteers are selected whose age and sex were similar to those of psoriasis patients. Brodalumab dosing was consistent with the label: 210 mg subcutaneously at Week 0, 1, and 2, and every 2 weeks thereafter until 12 weeks. The primary efficacy endpoints were: (i) clinical changes in terms of PASI score and PASI score 0 achievement rate at Week 12, (ii) molecular profile changes from Week 0 (baseline) to Week 12, and (iii) changes in inflammation-related and cardiovascular risk factors at Week12.