PT -期刊文章盟Xavier好吃的非盟-布鲁斯·科恩AU -托马斯Leist盟-哈罗德·摩西AU -安东尼Hamlett AU -马修Scaramozza盟娜塔莉Lachenal TI -口服Cladribine当添加干扰素β在多发性硬化症患者积极治疗:从第二阶段开始研究结果(P07.099) DP - 2013年2月12日TA -神经病学PG - P07.099 P07.099 VI - 80 IP - 7补充4099 - //www.ez-admanager.com/content/80/7_Supplement/P07.099.short 4100 - //www.ez-admanager.com/content/80/7_Supplem首页ent/P07.099.full所以Neurology2013 2月12;80 AB -目的:从开始研究报告发现,评估口服cladribine作为附加的安全性和耐受性interferonbeta女士(IFN-ß)活动性疾病患者。背景:本研究是第一个评价cladribine作为潜在的安全性和耐受性附加疗法治疗MS患者经历活动性疾病尽管IFN-β治疗。96周的双盲期完成cladribine发展项目时停止;安全性和探索有效性结果从这个审判的核心部分。设计/方法:患者18 - 65岁活跃女士被随机分配接受3.5毫克/公斤cladribine或安慰剂,添加在干扰素β治疗96周的双盲期间(菲律宾)。安全端点包括不良事件(AEs)和实验室参数。复发也提出了。结果:172名患者被随机分配在菲律宾和接收3.5毫克/公斤cladribine (n = 124)或安慰剂(n = 48),在干扰素β。AEs和节约的总体发生率治疗组之间比较,除淋巴细胞减少。 A greater proportion of cladribine add-on patients (63.7%) experienced CTCAE Grade 3-4 lymphopenia, as compared to placebo add-on patients (2.1%). There was a slightly higher incidence of infections in cladribine-treated group vs. placebo (61.3% vs. 54.2%). Four infections were SAEs (all in cladribine-treated patients), and no unexpected opportunistic infections were reported. One patient developed a malignancy during the study: squamous cell carcinoma, 2.35 years after first cladribine exposure. The patient's risk factor included a 25-year smoking history. Patients receiving cladribine add-on were 62% less likely to have a qualifying relapse, as compared to patients receiving placebo add-on.CONCLUSIONS: No new or unexpected safety issues were found. The combination therapy appeared effective; however efficacy analyses were not powered. An excess of grade 3 lymphopenia, compared with that reported in previous cladribine studies was observed which may be partly attributable to the concomitant administration of IFN-β.Supported by: Merck Serono S.A., Geneva, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany.Disclosure: Dr. Montalban has received personal compensation for activities with Bayer Schering Pharma, Biogen Idec, EMD Serono, Genentech, Genzyme, Novartis, and Sanofi-Aventis. Dr. Cohen has received personal compensation for activities with Astellis, Biogen Idec, EMD Serono, Genzyme Corporation, Sanofi-Aventis Pharmaceuticals, Inc., and Teva Neurscience. Dr. Cohen has received research support from Teva Neuroscience, the National Institutes of Health, Biogen Idec, EMD Serono, Novartis, and Roche. Dr. Leist has received personal compensation for activities with EMD Serono, Teva Neuroscience, Biogen, Bayer, and Pfizer as a consultant. Dr. Leist has received research support from EMD Serono, Teva Neuroscience, Bayer, ONO, Novartis Daishi, Acorda. Dr. Moses has received personal compensation for activities with EMD Serono, Teva, Biogen Idec, Bayer, Novartis, Questcor, Actelion, Genzyme Corporation, and Acorda Therapeutics. Dr. Hamlett has received personal compensation for activities with EMD Serono as an employee. Dr. Scaramozza has received personal compensation for activities with Pfizer research, employed by inVentiv Clinical Solutions, Inc. as an onsite consultant. Dr. Lachenal is an employee of Merck Serono.Thursday, March 21 2013, 2:00 pm-7:00 pm