Continuous long-term immunomodulatory therapy in relapsing multiple sclerosis: results from the 15-year analysis of the US prospective open-label study of glatiramer acetate.
Continuous long-term immunomodulatory therapy in relapsing multiple sclerosis: results from the 15-year analysis of the US prospective open-label study of glatiramer acetate.
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DOI：
10.1177/1352458509358088
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发表时间：
2010-03
期刊：
影响因子：
--
通讯作者：
Wolinsky J
中科院分区：
文献类型：
--
作者：
Ford C;Goodman AD;Johnson K;Kachuck N;Lindsey JW;Lisak R;Luzzio C;Myers L;Panitch H;Preiningerova J;Pruitt A;Rose J;Rus H;Wolinsky J
正在进行的美国醋酸格拉替雷（GA）试验是对 复发缓解型多发性硬化的持续免疫调节治疗 （RRMS）。本研究的目的是评估长达15年的GA作为一种 唯一的疾病缓解疗法共收治232名患者 自1991年研究开始以来至少一次GA剂量（mITT队列），100例（43%， 正在进行的队列）持续至2008年2月。每6个月对患者进行一次评估 使用扩展残疾状态量表（EDSS）。平均GA暴露量为 8.6±5.2、4.81 ±3.69和13.6 ± 1.3年， mITT、退出和正在进行的平均疾病持续时间分别为17、13和22年 各支球队，分别。对于正在进行的患者，年复发率（ARR） 维持从基线时的1.12±0.82下降至0.25 ± 0.82。 0.34 57%的患者EDSS评分稳定/改善（变化± 0.5 分）; 65%未转变为继发进行性多发性硬化症 （SPMS）; 38%，18%和3%达到EDSS 4，6和8。对于所有GA患者 治疗（mITT队列），ARR从1.18 ± 0.82降至0.43 ± 0.58/年; 54%的EDSS评分稳定/改善; 75%的EDSS评分无变化 过渡到SPMS; 39%、23%和5%达到EDSS 4、6和8。最后，我谨指出， 平均病程22年的多发性硬化患者， GA长达15年的复发率降低，残疾减少 升级和过渡到SPMS。无长期安全性问题。
The ongoing US Glatiramer Acetate (GA) Trial is the longest evaluation of continuous immunomodulatory therapy in relapsing-remitting multiple sclerosis (RRMS). The objective of this study was to evaluate up to 15 years of GA as a sole disease-modifying therapy. Two hundred and thirty-two patients received at least one GA dose since study initiation in 1991 (mITT cohort), and 100 (43%, Ongoing cohort) continued as of February 2008. Patients were evaluated every 6 months using the Expanded Disability Status Scale (EDSS). Mean GA exposures were 8.6 ±5.2, 4.81 ±3.69, and 13.6 ± 1.3 years and mean disease durations were 17, 13, and 22 years for mITT, Withdrawn and Ongoing cohorts, respectively. For Ongoing patients, annual relapse rates (ARRs) maintained a decline from 1.12±0.82 at baseline to 0.25 ± 0.34 per year; 57% had stable/improved EDSS scores (change ± 0.5 points); 65% had not transitioned to secondary progressive multiple sclerosis (SPMS); 38%, 18%, and 3% reached EDSS 4, 6, and 8. For all patients on GA therapy (the mITT cohort), ARRs declined from 1.18 ± 0.82 to 0.43 ± 0.58 per year; 54% had stable/improved EDSS scores; 75% had not transitioned to SPMS; 39%, 23%, and 5% reached EDSS 4, 6, and 8. In conclusion, multiple sclerosis patients with mean disease duration of 22 years administering GA for up to 15 years had reduced relapse rates, and decreased disability progression and transition to SPMS. There were no long-term safety issues.
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影响因子：
3.5
作者：
Johnson, KP;Ford, CC;Wolinsky, JS
通讯作者：
Wolinsky, JS
影响因子：
9.9
作者：
Fisher, E;Rudick, RA;Simonian, NA
通讯作者：
Simonian, NA
影响因子：
168.9
作者：
Kappos, L;Polman, C;Toyka, K
通讯作者：
Toyka, K
影响因子：
11.2
作者：
Wolinsky, Jerry S.;Narayana, Pormada A.;Laclkani, David
通讯作者：
Laclkani, David
影响因子：
9.9
作者：
Brown, M. G.;Kirby, S.;Sketris, I. S.
通讯作者：
Sketris, I. S.