TY - T1的患者的妊娠结局Teriflunomide对待女士:临床试验和上市后数据(P4.361) JF -神经学乔-神经学六世- 90 - 15补充SP - P4.361 AU -桑德拉Vukusic AU -帕特里夏·k·科伊尔非盟-斯蒂芬妮Jurgensen首页盟- Philippe Truffinet盟Myriam Benamor AU -伊丽莎白·普尔AU -杰弗里Chavin盟克里斯蒂娜·钱伯斯Y1 - 2018/04/10 UR - //www.ez-admanager.com/content/90/15_Supplement/P4.361.abstract N2 -目的:报告怀孕的结果发生在Teriflunomide上市后临床研究(CS)和(PM)设置。背景:Teriflunomide被批准用于治疗复发形式的女士在80个国家,162000 ~(自批准的接触。对人类致畸性teriflunomide CS显示无信号。此外,没有产生畸形的信号监测母体化合物的报道点,leflunomide(自1998年以来批准用于风湿性关节炎)。然而,teriflunomide孕期禁忌的基于embryo-fetal毒性在老鼠和兔子。尽管要求可靠的避孕、怀孕发生在teriflunomide-treated病人。设计/方法:总结了女性患者妊娠结局teriflunomide在单一治疗CS或点设置(不包括怀孕登记情况下)。数据截止5月17日,2016年。结果:总体而言,62怀孕被报道在CS和169年点设置。在129年怀孕与已知的结果,报告了99(包括所有CS病例)前瞻性:出生(n = 42),选择性堕胎(n = 38),自发流产(n = 17)、异位妊娠(n = 2)。回顾性报告结果(n = 30)是:出生(n = 10),选择性堕胎(n = 9),自然流产(n = 10),胎儿死亡(n = 1; ≥20 gestation weeks). No malformations/abnormalities were reported with elective abortions. An accelerated elimination procedure for teriflunomide was used in 82% of CS and 60% of PM cases with live births. Last dose of teriflunomide was administered at pre-conception or in the first trimester for all but 4 cases; all were PM cases, 3 exposed in the second and 1 in the third trimester. Three structural abnormalities were reported: ureteropyeloectasia in a newborn CS case (pre-term infant), congenital hydrocephalus (full-term), and cystic hygroma (on antenatal ultrasound; outcome unknown) in separate PM cases.Conclusions: Current data from teriflunomide-exposed pregnancies show no teratogenic signal, consistent with the 20-year PM experience with leflunomide. These data provide valuable information to healthcare providers and female patients of child-bearing potential.Study Supported by: Sanofi.Disclosure: Dr. Vukusic 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. Jurgensen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi, with ownership interest. Dr. Jurgensen has received compensation for serving on the Board of Directors of Employee of Sanofi, with ownership interest. Dr. Truffinet has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi, with ownership interest. Dr. Truffinet has received compensation for serving on the Board of Directors of Employee of Sanofi, with ownership interest. Dr. Benamor has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi. Dr. Poole has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi. Dr. Chavin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi. Dr. Chambers has received personal compensation in an editorial capacity for Compensation for serving as Editor, Associate Editor, or member of an editorial advisory board (Birth Defects Research Part A: Clinical and Molecular Teratology). Dr. Chambers has received research support from Research support unrelated to this study (AAAAI/VAMPS, AbbVie Laboratories, Amgen Inc., Bristol-Myers/Squibb, Celgene, Genzyme Sanofi-Aventis, GlaxoSmithKline, Hoffman-La Roche-Genentech, Janssen Pharmaceuticals, Pfizer, Inc., Seqirus, Takeda, UCB USA). ER -