Asahina Akihiko, Okubo Yukari, Morita Akimichi, Tada Yayoi, Igarashi Atsuyuki, Langley Richard G, Deherder Delphine, Matano Mizuho, Vanvoorden Veerle, Wang Maggie, Ohtsuki Mamitaro, Nakagawa Hidemi
Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
Dermatol Ther (Heidelb). 2023 Mar;13(3):751-768. doi: 10.1007/s13555-022-00883-y. Epub 2023 Jan 17.
INTRODUCTION: Bimekizumab treatment resulted in improved clinical outcomes in patients with moderate-to-severe plaque psoriasis in BE VIVID, a 52-week, phase 3, randomized, ustekinumab and placebo-controlled study. We present data from the BE VIVID Japan patient subpopulation. METHODS: Globally, patients were randomized to receive bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16, then bimekizumab 320 mg Q4W). Efficacy endpoints included week 16 Psoriasis Area and Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) 0/1, and other outcomes [PASI 100, PASI 75, IGA 0, Dermatology Life Quality Index (DLQI) 0/1, absolute PASI, scalp IGA, Psoriasis Symptoms and Impacts Measure (P-SIM) responses]. Safety analyses were conducted. RESULTS: There were 108 Japanese randomized patients (bimekizumab: 62; ustekinumab: 29; placebo: 17). At week 16, bimekizumab-treated patients had a higher clinical response versus ustekinumab and placebo (PASI 90: 85.5% versus 51.7% and 5.9%; IGA 0/1: 82.3% versus 48.3% and 0.0%). Over 52 weeks, improved clinical response was maintained with bimekizumab, including patients switching from placebo at week 16. Overall, the safety profile in Japanese patients was consistent with that observed in the global population. CONCLUSION: Bimekizumab resulted in improved clinical response versus ustekinumab and placebo, and was well-tolerated in Japanese patients. TRIAL REGISTRATION: NCT03370133.
简介:在一项为期52周的3期随机、优特克单抗和安慰剂对照研究BE VIVID中,比美吉珠单抗治疗使中度至重度斑块状银屑病患者的临床结局得到改善。我们展示了BE VIVID日本患者亚组的数据。 方法:在全球范围内,患者被随机分配接受每4周一次的320 mg比美吉珠单抗(Q4W)、优特克单抗(基线和第4周时根据体重给予45/90 mg,然后每12周一次)或安慰剂(第16周前每4周一次,然后每4周一次给予320 mg比美吉珠单抗)。疗效终点包括第16周的银屑病面积和严重程度指数(PASI)90以及研究者整体评估(IGA)0/1,以及其他结局指标[PASI 100、PASI 75、IGA 0、皮肤病生活质量指数(DLQI)0/1、绝对PASI、头皮IGA、银屑病症状和影响测量(P-SIM)反应]。进行了安全性分析。 结果:有108名日本随机分组患者(比美吉珠单抗组:62名;优特克单抗组:29名;安慰剂组:17名)。在第16周时,接受比美吉珠单抗治疗的患者与接受优特克单抗和安慰剂治疗的患者相比,临床反应更高(PASI 90:85.5%对51.7%和5.9%;IGA 0/1:82.3%对48.3%和0.0%)。在52周内,比美吉珠单抗维持了改善的临床反应,包括在第16周从安慰剂组转换过来的患者。总体而言,日本患者的安全性特征与全球人群中观察到的一致。 结论:与优特克单抗和安慰剂相比,比美吉珠单抗使临床反应得到改善,并且在日本患者中耐受性良好。 试验注册:NCT03370133
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