Jiwon哦% % 0期刊文章%阿娜特Achiron %克里斯蒂娜钱伯斯%爱德华狐狸%帕梅拉McCombe %苏珊娜Otero % Margolin大卫% % D阿拉斯泰尔•Compston %琳达Kasten T妊娠结果名RRMS患者接受阿仑单抗临床开发项目(S24.008) % D J神经病学2016% % P S24.008 X % V % 86% N 16补充目的:提供更新alemtuzumab-treated女性患者妊娠结局的临床发展项目。首页背景:评估疾病修饰治疗对妊娠的影响是很重要的,因为女士经常在育龄妇女诊断的。小鼠的研究并没有表明alemtuzumab-related致畸性尽管淋巴细胞计数的变化。迄今为止,尚无对照临床研究怀孕阿仑单抗的存在。妇女的生育潜力建议使用有效的避孕接受阿仑单抗后4个月。设计/方法:在第二阶段(CAMMS223 [NCT00050778])和第三阶段(CARE-MS我[NCT00530348], CARE-MS II [NCT00548405])的研究中,患者接受年度疗程的阿仑单抗。病人可能会进入一个扩展研究(NCT00930553),与需阿仑单抗再处理(≥1年除外)复发/放射活动。阿仑单抗低或血清中检测不到给药后30天内。怀孕或哺乳期患者不能接受治疗但仍为安全后续研究。结果:7月1日,2015年,193怀孕发生(136 972 alemtuzumab-treated女性患者; mean age at conception, 31.5 years) of which 167 were completed, 16 were ongoing, and 10 had unknown outcomes. Of completed pregnancies with known outcomes, 110 (66[percnt]) were live births with no congenital abnormalities or birth defects. There were 37 (22[percnt]) spontaneous abortions, 19 (11[percnt]) elective abortions, and 1 (0.6[percnt]) previously reported stillbirth. Elective abortions were due to personal choice (n=6), extrauterine pregnancy (n=3), anembryonic gestation (n=2), or fetal defect (n=1; previously reported cystic hygroma and hypoplastic heart); 7 had no information available. CONCLUSIONS: Based on cumulative experience in the alemtuzumab MS clinical studies, the most common outcome was full-term live birth. Delivered infants showed no birth defects. The rate of spontaneous abortion was comparable with rates observed in treatment-naive MS patients (up to 26[percnt]) and general populations (up to 22[percnt]), but needs further surveillance. STUDY SUPPORTED BY: Genzyme, a Sanofi company, and Bayer Healthcare Pharmaceuticals.Disclosure: Dr. Oh has received personal compensation for activities with EMD-Serono, Teva, Genzyme, Biogen-Idec, and Novartis as a consultant or speaker. Dr. Achiron has received personal compensation from Teva Pharmaceutical Industries, Sanofi-Genzyme and Novartis for serving on scientific advisory board and as a consultant. Dr. Christina Chambers has received personal compensation in an editorial capacity for Birth Defects Research Part A: Clinical and Molecular Teratology. Dr. Fox has received research support from Biogen, Chugai, Eli Lily, EMD Serono, Genzyme, Novartis, Opexa, Roche. Dr. McCombe has nothing to disclose. Dr. Otero has received personal compensation for activities with EMD Serono as a speaker. Dr. Margolin has received personal compensation for activities with Genzyme as an employee. Dr. Kasten has received personal compensation for activities with PROMETRIKA as an employee. Dr. Compston has received personal compensation for activities with Genzyme and Bayer Schering.Monday, April 18 2016, 3:30 pm-5:30 pm %U