临床研究可以告诉我们evobrutinib(一种治疗多发性硬化症的潜在药物)的安全性。

IF 2.3 Q3 CLINICAL NEUROLOGY Neurodegenerative disease management Pub Date : 2023-08-01 DOI:10.2217/nmt-2023-0003
Xavier Montalban, Daniel Wallace, Mark C Genovese, Davorka Tomic, Dana Parsons-Rich, Claire Le Bolay, Amy H Kao, Hans Guehring
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引用次数: 0

摘要

这个总结是关于什么的?本摘要解释了最近一项调查的结果,该调查结合了来自三个临床研究的1000多人的结果,以了解evobrutinib的安全性。Evobrutinib是一种口服药物(口服),正在研究作为多发性硬化症(MS)的潜在治疗方法。这种药物也被用于类风湿关节炎(RA)和系统性红斑狼疮(SLE)。超过1000人服用依沃鲁替尼作为三个独立的二期临床研究的一部分。这些研究着眼于应该服用多少药物,药物的安全性,以及它对治疗某种疾病的效果如何。结果如何?Evobrutinib在所有三项研究中的耐受性良好。服用这种药物的参与者报告的副作用数量与服用安慰剂(一种没有真正药物的“假”治疗)的参与者报告的副作用数量非常相似。临床研究中最常见的副作用是尿路感染、头痛、鼻子和喉咙肿胀、腹泻和潜在肝损伤的血液标志物(这些在治疗停止后恢复正常)。这些结果意味着什么?三项临床研究的安全性数据令人鼓舞,可用于进一步研究evobrutinib在ms中的应用。临床试验注册号:NCT02975349(多发性硬化症)、NCT03233230(类风湿性关节炎)、NCT02975336(系统性红斑狼疮)(ClinicalTrials.gov)。
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A plain language summary of what clinical studies can tell us about the safety of evobrutinib - a potential treatment for multiple sclerosis.

What is this summary about?: This summary explains the findings from a recent investigation that combined the results of over 1000 people from three clinical studies to understand the safety of evobrutinib. Evobrutinib is an oral medication (taken by mouth), being researched as a potential treatment for multiple sclerosis (MS). This medication was also investigated in rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Over 1000 people have taken evobrutinib as part of three separate phase 2 clinical studies. These studies looked at how much of the drug should be taken, how safe the drug is, and how well it might work for treating a certain medical condition.

What were the results?: Evobrutinib was well-tolerated by participants in all three studies. The number of side effects reported by participants taking the medication was very similar to those reported by participants taking the placebo (a 'dummy' treatment without a real drug). The most common side effects in clinical studies were urinary tract infections, headache, swelling of the nose and throat, diarrhoea and blood markers of potential liver damage (these returned to normal once the treatment was stopped).

What do the results mean?: The safety data from all three clinical studies are encouraging and can be used to inform further research into using evobrutinib in MS. Clinical Trial Registration: NCT02975349 (multiple sclerosis), NCT03233230 (rheumatoid arthritis), NCT02975336 (systemic lupus erythematosus) (ClinicalTrials.gov).

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