瑞桑基祖马布:作用机制,临床和转化科学
Yinuo Pang1, Ronilda D'Cunha1, Insa Winzenborg2
1Clinical Pharmacology, AbbVie, Inc., North Chicago, Illinois, USA.
Clinical and translational science
|January 24, 2024
概括
瑞桑基祖马布是一种抗联素-23抗体,有效治疗炎症性疾病,如斑块性牛皮,牛皮关节炎和克罗恩病. 临床数据证实了该药物在这些适应症中具有良好的疗效和安全性.
科学领域:
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
- 胃肠病学 胃肠病学
背景情况:
- 瑞桑基祖马布是一种单克隆抗体,向互白素-23 (IL-23).
- 它已获得全球批准用于治疗斑块性牛皮,牛皮关节炎和克罗恩病.
研究的目的:
- 审查监管批准,作用机制,药理动力学,药理动力学,免疫性和risankizumab的临床数据.
- 专注于治疗斑块性牛皮,牛皮性关节炎和克罗恩病的疗效和安全性.
主要方法:
- 审查监管提交和关键临床试验数据.
- 对药理动力学/药理动力学,免疫性和生物标志物数据的分析.
- 在开放式扩展研究中评估长期安全性.
主要成果:
- 瑞桑基祖马布通过与其p19亚单元结合来中和IL-23,从而抑制下游信号传输.
- 药理动力学是线性的和时间独立的,是IgG1抗体的典型特征.
- 积极的暴露-反应疗效,没有与暴露相关的安全问题.
- 免疫性没有显著影响疗效或安全性.
- 关键试验表明,与安慰剂/活性比较剂相比,益处风险优越.
- 长期研究显示稳定和有利的安全性.
结论:
- 瑞桑基祖马布证明了对斑块性牛皮,牛皮性关节炎和克罗恩病的有效性和安全性.
- 它的作用机制得到了生物标志物数据的证实.
- 该药物为管理这些炎症性疾病提供了有利的益处/风险概况.
相关概念视频
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
137
Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
137
The JAK-STAT Signaling Pathway
8.9K
Several cytokine receptors have tightly bound Janus kinase or JAK proteins attached at their cytosolic tail. Small signaling molecules such as cytokines, growth hormones, or prolactins bind to the cytokine receptors and initiate their dimerization. The dimerization brings the cytosolic JAKs together that trans-phosphorylate and activates each other. The activated JAKs now phosphorylate cytosolic tails of the cytokine receptors, which serve as binding sites for adaptor proteins such as SH2...
8.9K


