JEADV:布达鲁(brodalumab)单抗治疗中重度斑块型银屑病的远期疗效和安全性

2022-03-19 医路坦克 MedSci原创

银屑病是一种慢性的、免疫调节的疾病,影响着全世界大约1.25亿人。本文评估接受Brodalab单抗治疗的中重度银屑病患者在120周内的疗效、有效率和安全结果。

    银屑病是一种慢性的、免疫调节的疾病,影响着全世界大约1.25亿人。银屑病还与其他疾病有关,包括银屑病关节炎、心血管疾病和精神疾病,并已被证明对患者的生活质量(QOL)有负面影响。

    白介素-17致炎细胞因子家族成员在银屑病患者皮肤中相对健康皮肤表达上调,并被认为在银屑病的发病机制中发挥核心作用。Brodalab是一种单抗,通过与IL-17受体共有的A亚单位结合来阻断多种IL-17家族细胞因子。Brodalab治疗使银屑病皮损的基因表达正常化到非皮损水平。在三个AMAGINE 3期试验中,Brodalab为中到重度银屑病患者提供了长达52周的高水平皮肤清除。在最近对AMAGINE-2和-3数据的综合分析中,在52周内接受批准剂量的Brodalab(每2周210毫克)的患者迅速实现了高水平的完全和持续的皮肤清除,并显示出比接受Ustekinumab的患者更大的总体累积治疗益处。在一项长期的开放标签延伸研究中,其中包括完成为期12周的第二阶段剂量范围研究的中到重度银屑病患者,在5年的Brodalab治疗期间,保持了高水平的皮肤清除,并改善了生活质量。

    尽管生物制品通常表现出很高的短期疗效和良好的长期耐受性,但一些研究表明,随着时间的推移,许多生物制品会失去疗效。随着时间的推移,疗效损失率可能会因患者性别、体重指数(BMI)、以前的生物用途以及不同生物制剂之间的不同而不同,尽管原因尚不清楚。持续的治疗效果,特别是完全的皮肤清除,是重要的,可能对患者质量产生有意义的积极影响。一些研究表明,银屑病面积严重指数(PASI)的改善和与健康相关的生活质量之间存在正相关,包括与达到PASI 90的患者相比,PASI在基线(PASI 100)上100%改善的患者的生活质量评分有意义的改善

    随着时间的推移,需要具有持续高效的生物制品。在这里,我们使用来自3期AMAGINE-2和3期研究的汇集数据来评估中到重度银屑病患者在120周内的应答率和安全结果,这些患者每2周服用Brodalab 210 mg。

    来自AMAGINE-2和-3的患者的安全性和有效性数据被汇集在一起,这些患者每两周连续服用Brodalab 210毫克,或在服用Brodalab 140毫克或安慰剂后每两周服用Brodalab 210毫克,一直持续到第12周。疗效数据使用观察数据、无应答者归责(NRI)以及NRI和缺失的随机假设的组合来解释缺失数据。PASI的绝对分数是通过混合效应模型、重复测量模型和多重归因得到的。

    根据120周的观察数据,连续服用Brodalab 210 mg组86%的患者达到了PASI 90,74%的患者达到了PASI 100。在12周时,58%的患者达到PASI≤1的绝对值;在52周时,这一比例增加到约80%,并持续到120周。在持续接受Brodalab 210毫克的患者中,Brodalab 暴露的中位持续时间为747天,经暴露调整后的治疗事件发生率为每100人年329例。120周的安全性与AMAGINE-2和-3初步研究的结果相当

    在服用Brodalab140毫克或安慰剂12周后改用Brodalab210毫克的患者显示出类似的皮肤清除和安全概况。

     Brodalab治疗耐受性良好,导致高水平的皮肤清除,并迅速达到并维持到120周,支持其长期有效性和安全性。

文献来源:Reich K,  Iversen L,  Puig L, Long-term efficacy and safety of brodalumab in moderate-to-severe plaque psoriasis,J Eur Acad Dermatol Venereol 2022 Mar 13;

 

 

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    2022-03-21 zxl733
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