Neurofilament light chain in a phase 2 clinical trial of ibudilast in progressive multiple sclerosis.
Neurofilament light chain in a phase 2 clinical trial of ibudilast in progressive multiple sclerosis.
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DOI：
10.1177/1352458520986956
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发表时间：
2021-11
期刊：
影响因子：
--
通讯作者：
Kuhle J
中科院分区：
文献类型：
--
作者：
Fox RJ;Raska P;Barro C;Karafa M;Konig V;Bermel RA;Chase M;Coffey CS;Goodman AD;Klawiter EC;Naismith RT;Kuhle J
用于进行性多发性硬化症(MS)的敏感和特异的生物标志物尚未建立。我们研究了神经细丝光(NFL)作为进展性MS治疗反应生物标志物的作用，以评估伊布司特100 mg/d是否改变进展性MS患者的血清和脑脊液中NFL的水平。这是一项为期2年的伊布司特治疗进展性MS临床试验(NCT01982942)的探索性分析，采集了239名受试者的血清样本，并用SiMoA免疫测定法对其进行了检测。重复测量的混合模型将LOG(NFL)作为响应变量。安慰剂组和异丁司特组的几何平均基线血清NFL分别为31.9和28.8pg/ml。安慰剂组和异丁司特组的几何平均基线脑脊液NFL分别为1150.8和1290.3 pg/ml。血清和脑脊液NFL在48周和96周的相关系数分别为0.52和0.78。96周以上，无论是血清(P=0.76)还是脑脊液(P=0.46)，两组间NFL差异均无统计学意义。在控制了可能影响NFL的因素后，未观察到异丁司特对血清或脑脊液中NFL的影响。异丁司特治疗与血清或脑脊液NFL的变化无关。
Sensitive and specific biomarkers for use in progressive multiple sclerosis (MS) have not been established. We investigate neurofilament light (NfL) as a treatment response biomarker in progressive MS. To evaluate whether ibudilast 100 mg/d alters serum and CSF levels of NfL in progressive MS In a protocol-defined exploratory analysis from a 2-year, phase 2 clinical trial of ibudilast in progressive MS (NCT01982942), serum samples were collected from 239 subjects and a subset contributed CSF and assayed using SIMOA immunoassay. A mixed model for repeated measurements yielded log(NfL) as the response variable. The geometric mean baseline serum NfL was 31.9 and 28.8 pg/ml in placebo and ibudilast groups, respectively. The geometric mean baseline CSF NfL was 1150.8 and 1290.3 pg/ml in placebo and ibudilast groups, respectively. Serum and CSF NfL correlations were r = 0.52 and 0.78 at week 48 and 96, respectively. Over 96 weeks, there was no between-group difference in NfL in either serum (P=0.76) or CSF (P=0.46). After controlling for factors that may affect NfL, no effect of ibudilast on NfL in either serum or CSF was observed. Ibudilast treatment was not associated with a change in either serum or CSF NfL.
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影响因子：
9.9
作者：
Barkhof, F.;Hulst, H. E.;Landin, R.
通讯作者：
Landin, R.
影响因子：
168.9
作者：
Lublin, Fred;Miller, David H.;Kappos, Ludwig
通讯作者：
Kappos, Ludwig
影响因子：
48
作者：
Sormani, Maria Pia;Bruzzi, Paolo
通讯作者：
Bruzzi, Paolo
影响因子：
9.9
作者：
Kapoor R;Smith KE;Allegretta M;Arnold DL;Carroll W;Comabella M;Furlan R;Harp C;Kuhle J;Leppert D;Plavina T;Sellebjerg F;Sincock C;Teunissen CE;Topalli I;von Raison F;Walker E;Fox RJ
通讯作者：
Fox RJ
DOI：
10.1056/nejmoa1803583
发表时间：
2018-08-30
期刊：
The New England journal of medicine
影响因子：
--
作者：
Fox RJ;Coffey CS;Conwit R;Cudkowicz ME;Gleason T;Goodman A;Klawiter EC;Matsuda K;McGovern M;Naismith RT;Ashokkumar A;Barnes J;Ecklund D;Klingner E;Koepp M;Long JD;Natarajan S;Thornell B;Yankey J;Bermel RA;Debbins JP;Huang X;Jagodnik P;Lowe MJ;Nakamura K;Narayanan S;Sakaie KE;Thoomukuntla B;Zhou X;Krieger S;Alvarez E;Apperson M;Bashir K;Cohen BA;Coyle PK;Delgado S;Dewitt LD;Flores A;Giesser BS;Goldman MD;Jubelt B;Lava N;Lynch SG;Moses H;Ontaneda D;Perumal JS;Racke M;Repovic P;Riley CS;Severson C;Shinnar S;Suski V;Weinstock-Guttman B;Yadav V;Zabeti A;NN102/SPRINT-MS Trial Investigators
通讯作者：
NN102/SPRINT-MS Trial Investigators