在复发性多发性硬化症患者中的克拉迪片:来自东南欧洲多发性硬化中心的现实世界多中心研究
Ivan Adamec1, Gregor Brecl Jakob2, Cecilia Rajda3
1Department of Neurology, University Hospital Center Zagreb, Zagreb, Croatia; School of Medicine, University of Zagreb, Zagreb, Croatia.
Journal of neuroimmunology
|August 3, 2023
概括
现实世界的数据显示,克拉德里宾片对治疗复发性多发性硬化症 (MS) 有效. 这种口服治疗证明了持续的疗效和与临床试验一致的安全性,没有发现新的安全性问题.
科学领域:
- 神经学 神经学
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 克拉迪宾是一种口服疾病修饰疗法,已批准用于高度活跃的复发性多发性硬化症 (MS).
- 现实世界的数据对于了解不同患者群体的治疗结果至关重要.
研究的目的:
- 评估在患有多发性硬化症 (pwMS) 的人群中克拉德里宾片的实际有效性和安全性.
- 提供支持在常规临床实践中使用克拉迪宾的证据.
主要方法:
- 追溯性,观察性,多中心,多国家研究.
- 包括5个欧洲国家的320 pwMS开始在克拉德里宾片上.
- 对临床结果的分析,包括扩展残疾状态量表 (EDSS) 的恶化,复发率和MRI活动.
主要成果:
- 观察到高率没有疾病活性证据 (NEDA-3):第一年为58.0%,第二年为54.2%.
- 显著的pwMS百分比仍然没有复发 (86.9%年1,86.5%年2) 和没有EDSS恶化 (91.6%年1,90.2%年2).
- 常见的不良事件包括感染和皮肤反应;最初超过50%的人注意到淋巴衰竭,随着时间的推移而减少. 报告了两个新的恶性瘤.
结论:
- 在pwMS中,克拉德里宾片的实际有效性与关键临床试验数据相比较.
- 在这项现实研究中观察到的安全概况与已知的发现保持一致,表明没有新的安全问题.
- 克拉迪布林片是一种有价值的口服治疗选择,用于高度活跃的复发性MS.
相关概念视频
01:11Clinical Trials: Overview
3.0K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.0K
01:16Clinical Trials
6.9K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
6.9K
01:21Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids
153
Glucocorticoids, a class of anti-inflammatory drugs, are pivotal in treating moderate to severe Crohn's disease by inducing remission. They exhibit their anti-inflammatory action by inhibiting the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α, interleukin (IL)-1, and chemokines like IL-8. In addition, they reduce the expression of inflammatory cell adhesion molecules and inhibit gene transcription of nitric oxide synthase, phospholipase A2, cyclooxygenase-2...
153
01:19Pharmacovigilance
891
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
891
01:24Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
173
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...
173
01:29Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
195
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...
195