比美吉珠单抗完全清除皮肤和指甲银屑病：III期/IIIb期研究中的疗效对比
Bimekizumab Complete Clearance of Both Skin and Nail Psoriasis: Comparative Efficacy in Phase III/IIIb Studies.
作者信息
Merola Joseph F, Warren Richard B, Thaçi Diamant, Gordon Kenneth B, Nishida Emi, Strober Bruce, Conrad Curdin, Kavanagh Sarah, López Pinto José Manuel, Hoepken Bengt, Gisondi Paolo
机构信息
Division of Rheumatology, Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, USA.
Dermatology Centre, Northern Care Alliance NHS Foundation Trust, Manchester, UK.
出版信息
Am J Clin Dermatol. 2025 Aug 31. doi: 10.1007/s40257-025-00968-2.
BACKGROUND
Nail psoriasis can have a substantial negative impact on both the physical and emotional well-being of patients, and is a risk factor for psoriatic arthritis. Achieving complete clearance of nails in addition to skin is therefore an important treatment goal.
OBJECTIVES
We aimed to evaluate concurrent complete skin and nail clearance in patients with moderate-to-severe plaque psoriasis treated with bimekizumab or active comparators.
METHODS
Data were analyzed from the BE SURE and BE VIVID phase III trials, their open-label extension BE BRIGHT, and the BE RADIANT phase IIIb trial and its open-label extension. Included patients had baseline modified Nail Psoriasis Severity Index (mNAPSI) >0 and entered their respective open-label extension. Proportions of patients achieving complete skin (PASI 100; 100% improvement from baseline in Psoriasis Area and Severity Index) and nail (mNAPSI 0) clearance at the same time are reported for bimekizumab- and active comparator-treated patients during controlled trial periods, and in the long term for continuous bimekizumab-treated patients and those switching from comparators. Data are reported using modified non-responder imputation.
RESULTS
At the end of comparator-controlled periods, 45.8% of bimekizumab (N = 151) versus 18.3% of adalimumab (N = 91) patients (BE SURE week 24), 51.1% of bimekizumab (N = 169) versus 26.5% of ustekinumab (N = 92) patients (BE VIVID week 52), and 63.3% of bimekizumab (N = 182) versus 36.1% of secukinumab (N = 155) patients (BE RADIANT week 48) achieved PASI 100 and mNAPSI 0. Following long-term treatment, 57.7% of adalimumab switchers/49.1% of continuous bimekizumab patients (BE SURE/BE BRIGHT year 4), 52.2% of ustekinumab switchers/48.3% of continuous bimekizumab patients (BE VIVID/BE BRIGHT year 4), and 51.9% of secukinumab switchers/57.4% of continuous bimekizumab patients (BE RADIANT year 3) achieved PASI 100 and mNAPSI 0.
CONCLUSIONS
Numerically higher proportions of bimekizumab-treated patients achieved concurrent complete skin and nail clearance versus adalimumab, ustekinumab, and secukinumab. Clearance rates increased following switch to bimekizumab, and were sustained long-term in both switchers to bimekizumab and continuous bimekizumab-treated patients. [Graphical abstract available.] CLINICAL TRIAL REGISTRATION: NCT03412747, NCT03370133, NCT03598790, NCT03536884.
背景
甲银屑病会对患者的身心健康产生重大负面影响，并且是银屑病关节炎的一个风险因素。因此，除皮肤外实现指甲的完全清除是一个重要的治疗目标。
目的
我们旨在评估接受比美吉珠单抗或活性对照药物治疗的中度至重度斑块状银屑病患者皮肤和指甲同时完全清除的情况。
方法
分析了BE SURE和BE VIVID III期试验、它们的开放标签扩展试验BE BRIGHT以及BE RADIANT IIIb期试验及其开放标签扩展试验的数据。纳入的患者基线改良甲银屑病严重程度指数（mNAPSI）>0，并进入各自的开放标签扩展试验。报告了在对照试验期内接受比美吉珠单抗和活性对照药物治疗的患者同时实现皮肤完全清除（PASI 100；银屑病面积和严重程度指数较基线改善100%）和指甲（mNAPSI 0）清除的比例，以及长期接受比美吉珠单抗持续治疗的患者和从对照药物转换而来的患者的情况。数据采用改良无应答者插补法报告。
结果
在对照药物对照期结束时，比美吉珠单抗组（N = 151）45.8%的患者对比阿达木单抗组（N = 91）18.3%的患者（BE SURE第24周）、比美吉珠单抗组（N = 169）51.1%的患者对比优特克单抗组（N = 92）26.5%的患者（BE VIVID第52周）、比美吉珠单抗组（N = 182）63.3%的患者对比司库奇尤单抗组（N = 155）36.1%的患者（BE RADIANT第48周）实现了PASI 100和mNAPSI 0。长期治疗后，阿达木单抗转换者/比美吉珠单抗持续治疗患者中57.7%/49.1%（BE SURE/BE BRIGHT第年4）、优特克单抗转换者/比美吉珠单抗持续治疗患者中52.2%/48.3%（BE VIVID/BE BRIGHT第年4）、司库奇尤单抗转换者/比美吉珠单抗持续治疗患者中51.9%/57.4%（BE RADIANT第3年）实现了PASI 100和mNAPSI 0。
结论
与阿达木单抗、优特克单抗和司库奇尤单抗相比，接受比美吉珠单抗治疗的患者在数量上实现皮肤和指甲同时完全清除的比例更高。转换为比美吉珠单抗后清除率增加，并且在转换为比美吉珠单抗的患者和接受比美吉珠单抗持续治疗的患者中均长期维持。[可获取图形摘要。]临床试验注册编号：NCT03412747、NCT03370133、NCT03598790、NCT03536884。
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