复发性多发性硬化症的有限疗程ocrelizumab:两个前性开放标签试验的结果与匹配的对照
Andrea Salazar-Camelo1, Lauren Vega1, Yasser Fadlallah1
1Department of Neurology, Johns Hopkins University, Baltimore, MD, USA.
Multiple sclerosis (Houndmills, Basingstoke, England)
|September 19, 2025
概括
在大多数复发性多发性硬化症患者中,两次ocrelizumab疗程维持了超过三年的缓解. 这种有限过程的抗CD20疗法显示出作为降级策略的希望,尽管需要进一步的研究.
科学领域:
- 神经免疫学 神经免疫学
- 临床神经学 临床神经学
- 药理学 药理学是指药理学的学科.
背景情况:
- 在复发性多发性硬化症 (MS) 中,持续控制疾病的持续抗CD20治疗的必要性仍然不清楚.
- 研究有限疗程治疗选择可以为MS管理提供新的治疗策略.
研究的目的:
- 评估两个ocrelizumab疗程是否可以在复发性多发性硬化症患者中实现和维持临床和放射性缓解.
- 为了比较有限的ocrelizumab治疗疗程与标准间隔剂量 (SID) 的疗效.
主要方法:
- 两项前性,开放性试验 (NCT03853746,NCT04261790) 的综合分析,涉及19名患有活性复发性MS的成年人.
- 患者接受了两次ocrelizumab疗程,长达46个月的随访,并与52名倾向性得分匹配的SID接受者进行了比较.
- 限制平均存活时间 (RMST) 用于分析到疾病重新激活的时间.
主要成果:
- 在接受有限剂量治疗的患者中,32%的患者出现了疾病的重新激活,而在SID组中,这一比例为0%.
- 再激活后的RMST为有限剂量的40.5个月,而SID为46.0个月 (p=0.011).
- 周围B细胞的重新填充并不能预测疾病的重新激活.
结论:
- 在大多数复发性多发性硬化症患者中,两次ocrelizumab的有限疗程维持了超过三年的临床稳定性.
- 这些发现表明,有限疗程的抗CD20疗法可能是一个可行的降级策略.
- 需要更大的随机或前性协调研究来证实这些产生假设的结果.
相关概念视频
01:11Clinical Trials: Overview
4.6K
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...
4.6K
01:16Crossover Experiments
4.5K
Crossover experiments, also called the repeated-measurements design, is a study design in which all experimental units are exposed to all treatments in different periods. Crossover experiments are generally used in psychology, the pharmaceutical industry, agriculture, and medicine.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
4.5K
01:16Clinical Trials
10.2K
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...
10.2K
01:29Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
493
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...
493
01:11Bioavailability Study Design: Single Versus Multiple Dose Studies
216
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
216
01:21Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids
439
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...
439