英弗利克西马布生物类似剂GP1111:对5年后批准经验的回顾
Thomas W J Huizinga1, Valeria Dipasquale2, Markus Zabransky3
1Department of Rheumatology, Leiden University Medical Center, Leiden University, Leiden, The Netherlands.
Expert opinion on biological therapy
|July 8, 2024
概括
简介:GP1111 (Zessly®) 是一种与因弗力西马布生物相似的药物,在类风湿性关节炎和炎症性肠病中表现出可比的疗效和安全性. 批准后的数据证实了其有效性和成本效益,支持其继续使用.
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.
- 类风湿病学 类风湿病学
背景情况:
- 恩弗利西马布是治疗自身免疫性疾病的关键生物疗法.
- GP1111是最近在欧洲获得批准的因弗利西马布的生物类似药.
- 审查重点关注类风湿性关节炎 (RA) 和炎症性肠病 (IBD) 迹象.
研究的目的:
- 审查GP1111.11的批准程序和证据.
- 评估GP1111.11的临床前,临床和现实世界的数据.
- 评估GP1111在RA和IBD中的安全性和有效性.
主要方法:
- 对临床前,临床 (REFLECTIONS 第三阶段试验) 和现实世界的数据进行审查.
- 从参考因弗利克西马布和其他生物类似药物转换研究的分析.
- 包括对RA治疗的预算影响分析.
主要成果:
- 第三阶段试验证实GP1111的疗效和安全性与RA中的参考因弗力西马布相似.
- 切换到GP1111没有对疗效或安全产生不良影响.
- 现实数据和预算影响分析支持GP1111的成本效益和持续使用.
结论:
- 经过五年的批准后经验支持GP1111的安全性和有效性.
- 临床和现实世界的证据验证了GP1111在所有已批准的适应症中的使用.
- GP1111是一种安全,有效和具有成本效益的治疗选择,用于RA和IBD.
相关概念视频
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
128
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...
128
Inflammatory Bowel Disease IV: Pharmacological Management
125
Upon diagnosis, managing Inflammatory Bowel Disease (IBD) involves addressing several crucial aspects. The primary goals include resting the bowel, correcting malnutrition, and providing symptomatic relief. Resting the bowel may consist of medications to reduce inflammation and promote healing. Correcting malnutrition is essential, often requiring dietary adjustments and nutritional supplements. Symptomatic relief aims to ease pain, diarrhea, and other discomforts in IBD.
Pharmacologic...
Pharmacologic...
125
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
156
Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel...
156


