在MS中需要对新药进行更密切的监测:西波尼莫德回顾性队列研究 (Realhes研究)
Arantxa Sancho-López1, Belén Ruiz-Antorán1, Teresa Iglesias Hernangómez2
1Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, 28222 Majadahonda, Spain.
多发性硬化症 (MS) 的西波尼莫德治疗导致淋巴缺血的发病率高于之前报告的. 由于临床实践中观察到的发病率和严重程度增加,对患者进行更密切的监测至关重要.
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:
- 在siponimod的临床试验中观察到淋巴细胞数量的减少,即淋巴细胞减少.
- 这种不良影响可能会影响西波尼莫德在多发性硬化症 (MS) 治疗中的整体益处/风险概况.
研究的目的:
- 在临床实践中评估siponimod启动后淋巴缺血的真实发病率.
- 分析与西波尼莫德治疗相关的淋巴缺血事件的诱导因素和临床意义.
主要方法:
- 一项多中心的回顾性队列研究,涉及15家西班牙三级医院的129名多发性硬化症患者.
- 患者开始接受西波尼莫德治疗,并被跟踪至少3个月,定期监测淋巴细胞数量.
主要成果:
- 在121名 (93.6%) 患者中观察到淋巴衰竭的高发病率,其中11名 (8.5%) 患有4级淋巴衰竭.
- 这些比率明显超过了在关键的siponimod临床试验中报告的比率 (73.3%等级≤3,3.3%等级4).
- 意外高比例的男性患者 (72.9%) 可能影响了观察到的风险大小.
结论:
- 在临床实践中,西波尼莫德启动后淋巴缺血的发生率和严重程度高于此前记录的.
- 强化了在现实环境中加强对新型多发性硬化疗法的监测的必要性.
- 较大,较长的随访研究对于全面了解西波尼莫德相关的淋巴缺血风险至关重要.
更多相关视频
08:40Positron Emission Tomography Imaging for In Vivo Measuring of Myelin Content in the Lysolecithin Rat Model of Multiple Sclerosis
Published on: February 28, 2021
12:27A Pipeline to Investigate the Structures and Signaling Pathways of Sphingosine 1-Phosphate Receptors
Published on: June 8, 2022
相关概念视频
Pharmacovigilance
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...
Clinical Trials: Overview
Clinical Trials
There are four phases in a clinical trial. A phase one...
Observational Studies
There are three types of observational studies – Prospective, retrospective, and cross-sectional.
Prospective Study
Prospective studies, also known as longitudinal or cohort studies, are carried out by collecting future data from groups sharing similar characteristics. One...
Chronic Obstructive Pulmonary Disease-IV: Assessement and Diagnostic Studies
Medical History
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
