Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis.
Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis.
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DOI：
10.1177/1352458520964409
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发表时间：
2021-08
期刊：
影响因子：
--
通讯作者：
Fox RJ
中科院分区：
文献类型：
--
作者：
Bermel RA;Fedler JK;Kaiser P;Novalis C;Schneebaum J;Klingner EA;Williams D;Yankey JW;Ecklund DJ;Chase M;Naismith RT;Klawiter EC;Goodman AD;Coffey CS;Fox RJ
SPRINT-MS试验证明了异丁司特在进行性MS中对脑萎缩的益处超过96周。在所有试验参与者中进行光学相干断层扫描（OCT）。报告SPRINT-MS试验的OCT结果。在基线和每6个月使用光谱域OCT获得OCT，并由OCT阅读中心进行分析。使用线性混合模型估计各治疗组OCT结局指标的变化。异丁司特组pRNFL厚度的变化为+0.0424uM/年（95%CI：-0.3091至0.3939），安慰剂组为-0.2630uM（95%CI：-0.5973至0.0714）（n=244，p=0.22）。在Spectralis队列中，异丁司特组的黄斑体积变化为− 0.00503 mm 3/年（−0.02693至0.01688），安慰剂组为− 0.03659 mm 3/年（−0.05824至−0.01494）（n=61，p=0.044）。对于Cirrus队列，异丁司特组黄斑体积变化为-0.00040 mm 3/年（-0.02167，0.020866），而安慰剂组为-0.02083 mm 3/年（-0.04134至-0.00033）（n=183，p=0.1734）。从Cirrus获得的神经节细胞内丛状层厚度变化为-0.4893uM/年（-0.9132，-0.0654），使用异丁司特与安慰剂（n=183，p=0.12）的-0.9587uM/年（-1.3677，-0.5498）。样本量估计表明，如果治疗具有较大的治疗效果，OCT可能是进展性MS试验中可行的结局指标。NN 102/SPRINT-MS ClinicalTrials.gov编号，NCT 01982942
The SPRINT-MS trial demonstrated benefit of ibudilast on brain atrophy over 96 weeks in progressive MS. Optical coherence tomography (OCT) was performed in all trial participants. Report the OCT results of the SPRINT-MS trial. OCT was obtained at baseline and every 6 months using spectral domain OCT and analyzed by an OCT reading center. Change in each OCT outcome measure by treatment group was estimated using linear mixed models. Change in pRNFL thickness was +0.0424uM/year (95% CI: −0.3091 to 0.3939) for ibudilast vs. − 0.2630uM (95%CI −0.5973 to 0.0714) for placebo (n=244, p=0.22). Macular volume change was − 0.00503mm3/year (−0.02693 to 0.01688) with ibudilast vs. −0.03659mm3/year (−0.05824 to −0.01494) for placebo in the Spectralis cohort (n=61, p=0.044). For the Cirrus cohort, macular volume change was −0.00040 mm3/year (−0.02167, 0.020866) with ibudilast compared to −0.02083 mm3/year (−0.04134 to −0.00033) for placebo (n=183, p=0.1734). Ganglion cell-inner plexiform layer thickness change, available from Cirrus, was −0.4893uM/year (−0.9132, −0.0654) with ibudilast vs. −0.9587uM/year (−1.3677, −0.5498) with placebo (n=183, p=0.12) Retinal thinning in MS may be attenuated by ibudilast. Sample size estimates suggest OCT can be a viable outcome measure in progressive MS trials if a therapy has a large treatment effect. NN102/SPRINT-MS ClinicalTrials.gov number, NCT01982942
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影响因子：
11.2
作者：
Sotirchos ES;Gonzalez Caldito N;Filippatou A;Fitzgerald KC;Murphy OC;Lambe J;Nguyen J;Button J;Ogbuokiri E;Crainiceanu CM;Prince JL;Calabresi PA;Saidha S;International Multiple Sclerosis Visual System (IMSVISUAL) Consortium
通讯作者：
International Multiple Sclerosis Visual System (IMSVISUAL) Consortium
影响因子：
11.2
作者：
Saidha S;Al-Louzi O;Ratchford JN;Bhargava P;Oh J;Newsome SD;Prince JL;Pham D;Roy S;van Zijl P;Balcer LJ;Frohman EM;Reich DS;Crainiceanu C;Calabresi PA
通讯作者：
Calabresi PA
影响因子：
5.7
作者：
Ruiz-Perez, Daniel;Benito, Javier;Gomez de Segura, Ignacio A.
通讯作者：
Gomez de Segura, Ignacio A.
影响因子：
5.8
作者：
Syc, Stephanie B.;Warner, Christina V.;Calabresi, Peter A.
通讯作者：
Calabresi, Peter A.
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