口腔复发缓和多发性硬化的ponesimod:随机二期试验。

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奥尔森T,博士德,费尔南德斯O,弗里德曼女士,Pozzilli C, D巴赫,Berkani O,米勒女士,Sidorenko T, Radue电子战,Melanson博士M

口腔复发缓和多发性硬化的ponesimod:随机二期试验。

J神经精神病学Neurosurg。2014年11月,85 (11):1198 - 208。doi: 10.1136 / jnnp - 2013 - 307282。Epub 2014年3月21日。

PubMed ID

24659797 (在PubMed

]

文摘

IIb阶段目标:这双盲,安慰剂对照,研究研究评估ponesimod的疗效和安全性,口服选择性S1P1受体调节剂,用于治疗复发缓和多发性硬化患者(名RRMS)。方法:随机抽取464名患者接受每日一次口腔ponesimod 10、20或40毫克或安慰剂24周。主要终点是累计数量的新T1 gadolinium-enhanced (T1 Gd +)病变每个病人记录每4周后从12到24周的研究药物的起始。二次端点是折合成年率证实复发率(ARR)和时间先确诊复发。安全性和耐受性也被评估。结果:平均累积许多新T1 Gd +病变在周12 - 24是显著降低ponesimod 10毫克(3.5;率比(RR) 0.57;p = 0.0318), 20毫克(1.1;RR 0.17;p < 0.0001)和40毫克(1.4; RR 0.23; p<0.0001) groups compared with placebo (6.2). The mean ARR was lower with 40 mg ponesimod versus placebo, with a maximum reduction of 52% (0.25 vs 0.53; p=0.0363). The time to first confirmed relapse was increased with ponesimod compared with placebo. The proportion of patients with >/= 1 treatment-emergent adverse events (AEs) was similar across ponesimod groups and the placebo group. Frequently reported AEs with higher incidence in the three ponesimod groups compared with placebo were anxiety, dizziness, dyspnoea, increased alanine aminotransferase, influenza, insomnia and peripheral oedema. CONCLUSIONS: Once-daily treatment with ponesimod 10, 20 or 40 mg significantly reduced the number of new T1 Gd+ lesions and showed a beneficial effect on clinical endpoints. Ponesimod was generally well tolerated, and further investigation of ponesimod for the treatment of RRMS is under consideration. TRIAL REGISTRATION NUMBER: NCT01006265.

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药物靶点

药物	目标	类	生物	药理作用	行动
Ponesimod	鞘氨醇1-phosphate受体1	蛋白质	人类	是的	受体激动剂 调制器 监管机构	细节