RT期刊文章SR电子T1的功效Cladribine平板电脑作为附加IFN-beta治疗患者积极复发:女士最终结果从第二阶段开始研究(P3.029)摩根富林明神经病学神经学乔FD Lippincott Williams &威尔金斯SP P3.029 VO 86是16补充A1 Xavier好吃的A1 Bruce Cohen A1托马斯Leist A1哈罗德·摩西A1 Christine首页乡下人A1费尔南多Dangond年2016 UL //www.ez-admanager.com/content/86/16_Supplement/P3.029.abstract AB目的:评估的有效性Cladribine平板电脑(3.5毫克/公斤)作为附加IFN-β活跃复发患者背景:女士Cladribine平板电脑每年给予2年的短期课程名RRMS患者显著提高临床和MRI结果(清晰)。在清晰的扩展,中国开放cladribine治疗的临床效益(3.5毫克/公斤体重)保持在学习了4年以上没有进一步积极治疗。开始评估的安全/耐受性cladribine平板电脑(3.5毫克/公斤)作为附加IFN-β疗法。这里报道效果。方法:开始是2年,随机、双盲IIb阶段研究18 - 65岁的病人,≥1复发前48周期间在IFN-β疗法,与eds得分1.0 - -5.5和正常血细胞计数的28天内基线。结果:14.5 (percnt) (N = 172)的患者在基线spm。排位赛复发的平均数量在研究低(0.23)患者cladribine 3.5毫克/公斤+ IFN-β(N = 124)与病人安慰剂加IFN-β(0.56;N = 48)。各自的arr 0.12 (95 [percnt]可信区间0.08,0.17)和0.32 (95 [percnt]可信区间0.20,0.45)。Cladribine-treated患者63 (percnt)不太可能有资格复发(P < 0.001)。 The proportion of patients with confirmed EDSS progression over 2 years was not significantly different for cladribine 3.5mg/kg plus IFN-β vs. placebo plus IFN-β; however, the study was not powered for this endpoint. The mean numbers of new T1-Gd+, active T2 and CUA lesions/patient/scan were reduced in the combined treatment arm vs. placebo plus IFN-β. Conclusions: In patients with active relapsing MS with breakthrough disease while on IFN-β therapy (including SPMS with ongoing relapses), treatment with cladribine tablets added on to IFN-β demonstrated significant efficacy benefits. These results support the demonstrated efficacy of cladribine tablets in RRMS shown in CLARITY. Study supported by: Merck KGaA Darmstadt, Germany.Disclosure: Dr. Montalban has received personal compensation for activities with Bayer Schering Pharma, Biogen Idec, EMD Serono ,Genentech, Genzyme, Novartis, Sanofi Aventis, Teva Pharmaceutical, and Almirall. Dr. Cohen has received personal compensation for activities with Accorda, Astellis, Biogen-Idec, EMD Serono, Inc., and Genzyme. Dr. Leist has received research support from EMD Serono, Teva Neuroscience, Bayer Healthcare, ONO Pharmaceutical, Novartis, Daiichi, and Acorda Pharmaceuticals. Dr. Moses has received personal compensation for activities with EMD Serono, Teva Neuroscience, Biogen Idec, Bayer Pharmaceuticals, Novartis, Questcor, Actelion, Genzyme, and Acorda Therapeutics. Dr. Hicking has received personal compensation for activities with Merck KGaA, Darmstadt, Germany as an employee. Dr. Dangond has received personal compensation for activities with EMD Serono, Inc. as an employee.Monday, April 18 2016, 8:30 am-7:00 pm
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