TY -的T1 -咪唑硫嘌呤和β干扰素疗效的直接比较多发性硬化症(P01.200) JF -神经学乔-神经病学SP - P01.200 LP - P01.200六世- 80 - 7补充AU -卢卡Massacesi盟-艾琳Tram首页acere AU -玛丽亚毕讷德提Donata盟-格拉Filippini AU - Loredana Lamantia AU -亚历山德拉·索拉里盟萨尔瓦多Amoroso AU -马里奥•巴塔利亚盟Gioacchino泰德斯盟-克拉拉米兰Y1 - 2013/02/12 UR - //www.ez-admanager.com/content/80/7_Supplement/P01.200.abstract N2 -目的:比较疗效和安全性的硫唑嘌呤(AZA)目前干扰素的临床和MRI结果复发缓和多发性硬化症(MS)的措施,通过多中心随机对照试验(RCT)。背景:批准后β干扰素(IFN)多发性硬化症(MS)、硫唑嘌呤(AZA)主要被用来作为二线治疗,尽管这些药物的直接比较从未执行。设计/方法:符合条件的患者(n = 150;复发缓和多发性硬化症;> 2 relapses in the last 2 years) were randomly assigned to AZA or to an IFN and followed for 2 years. Primary outcome was efficacy on relapse rate. Key secondary outcome was number of new brain lesion, measured by MRI via T2 weighted sequences. For MRI evaluation 122 patients were included. The efficacy of these treatments was compared by applying a non-inferiority design according to published guidelines.RESULTS: As for baseline characteristics, the randomization generated comparable groups (n= 77 and 73). Clinical evaluation indicates that annualized relapse rate was lower in the AZA than in the IFN group and non-inferiority analysis showed that AZA exerts on this outcome measure at least the same effect of IFNs (0.67%, one sided 95% C.I.= 0.96; p= 0.03). New T2 lesion number analyzed in 97 patients, was similar in both groups indicating that AZA maintains also on this outcome at least 73% of the IFN efficacy (p= 0.05). Number of patients with adverse events (AE) and patients who discontinued treatment for AEs were similar in both the treatment groups although total AE number was higher in the AZA treated group.CONCLUSIONS: These data indicate for the first time, that in relapsing remitting MS AZA is at least as effective as IFNs on clinical outcome measures and that its efficacy on suppressing new brain lesions is equivalent to that of the IFNs.Supported by: Italian Medicines Agency(Agenzia Italiana del Farmaco; AIFA).Disclosure: Dr. Massacesi has received personal compensation for activities with Biogen Idec, Merk-Serono, Sanofi-Aventis, Novartis, and the European Medicine Agency. Dr. Tramacere has nothing to disclose. Dr. Benedetti has nothing to disclose. Dr. Filippini has nothing to disclose. Dr. Lamantia has nothing to disclose. Dr. Solari was a board member for Novartis, Biogenidec and Merck Serono, and has received speaker honoraria from Sanofi-Aventis. Dr. Amoroso has nothing to disclose. Dr. Battaglia has nothing to disclose. Dr. Tedeschi has received research support from Biogen-Idec, Merk-Serono, Sanofi-Aventis and Novartis. Dr. Milanese has nothing to disclose.Monday, March 18 2013, 2:00 pm-6:30 pm ER -