TY -的T1 - 2剂的临床疗效和安全性Ponesimod(10和20毫克的外径):临时分析二期复发缓和多发性硬化的扩展试验(P3.398) JF -神经学乔-神经学六世- 90 - 15补充SP - P3.398 AU - Eva Havrdova盟阿娜特Achiron AU -帕特丽夏Coyle盟-丹尼尔·D 'Ambrosio盟Juha-Pekka Era首页linna AU -布莱恩轩尼诗盟Ewa Lindenstroem AU - Jan Lycke盟Guillermo Izquierdo AU -卡洛Pozzilli盟马克弗里德曼Y1 - 2018/04/10 UR - //www.ez-admanager.com/content/90/15_Supplement/P3.398.abstract N2 -目的:比较疗效和安全性Ponesimod 20毫克(P20)和10毫克(P10)患者的复发缓和多发性硬化(名RRMS)。背景:每天一次(外径)口服治疗ponesimod,小说选择性S1P1受体调节剂,显示临床效益和减少MRI活动第二阶段安慰剂对照试验中名RRMS[我]。患者持续扩展的审判目前收到10或20毫克的ponesimod的外径。设计/方法:临时集中数据的分析从病人随机P10或P20核心试验或其扩展。结果:6年,kaplan meier持续确认残疾的风险积累是P10及P20的29.6%和16.4%,分别(相对风险降低(存款准备金率):49%;95%置信区间:8 - 72%;p = 0.024)。年度确认的复发率是0.227和0.153 P10和P20的手臂,分别(存款准备金率:32.5%(95%置信区间CI:−3.6 - -56.1%;p = 0.07)。T1钆增强病变的平均数量/主题/扫描1.371和0.768的P10及P20 mg的手臂,分别(RR: 44%(95%置信区间CI: 14.7 - -63.2%;p = 0.007)。 The mean number of new or enlarging T2 lesions per subject per 24 weeks was 0.884 and 0.293 in the P10 and P20 arm, respectively (RRR: 66.9% [95% CI: 50.3–77.9%; p < 0.0001]). The proportion of patients (%) with all adverse events (AEs), serious AEs, and AEs leading to treatment discontinuation was 94.2 vs. 91.0, 15.1 vs. 13.8, and 12.2 vs. 10.3 in P10 and P20, respectively.Conclusions: Ponesimod 20 mg o.d. compared to 10 mg o.d. has better clinical and MRI outcomes with similar safety profile.Study Supported by: Actelion Pharmaceuticals Ltd.Disclosure: Dr. Havrdová has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion, Biogen, Celgene, Merck, Novartis, Sanofi Genzyme, Teva. Dr. Achiron has nothing to disclose. Dr. Coyle has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consulting fees (AbbVie, Accordant, Acorda, Bayer, Biogen Idec, Celgene, Genentech/Roche, Genzyme/Sanofi, Novartis, Serono, Teva). Dr. Coyle has received research support from Research support (Actelion, Alkermes, Genentech/Roche, MedDay, NINDS, Novartis, Opexa). Dr. D'Ambrosio has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion. Dr. D'Ambrosio holds stock and/or stock options in J&J and Idorsia. Dr. Eralinna has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merck, Novartis, Roche, Sanofi Genzyme, Teva. Dr. Hennessy has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion. Dr. Lindenstroem has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion. Dr. Lycke has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi Genzyme, Merck, Novartis, Teva. Dr. Lycke has received research support from Novartis, Teva. Dr. Izquierdo Ayuso has nothing to disclose. Dr. Pozzilli has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion, Biogen, Merck, Novartis, Sanofi, and Teva. Dr. Pozzilli has received research support from Actelion, Biogen, Merck, Novartis, Sanofi, and Teva. Dr. Freedman has received personal compensation for activities compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion, Bayer Healthcare, Biogen, Canada Innovation, Chugai, Clene Nanomedicine, EMD Canada, Hoffman-La Roche, Merck Serono, Novartis, Opexa, Sanofi Aventis, Sanofi Genzyme, and Teva. ER -