@article{b4b8b3ae88474a4a88270039a5539d23,
title = "Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis",
abstract = "Background: The SPRINT-MS trial demonstrated benefit of ibudilast on brain atrophy over 96 weeks in progressive multiple sclerosis (MS). Optical coherence tomography (OCT) was performed in all trial participants. Objective: Report the OCT results of the SPRINT-MS trial. Methods: 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. Results: Change in pRNFL thickness was +0.0424 uM/year (95% confidence interval (CI): −0.3091 to 0.3939) for ibudilast versus −0.2630 uM (95% CI: −0.5973 to 0.0714) for placebo (n = 244, p = 0.22). Macular volume change was −0.00503 mm3/year (−0.02693 to 0.01688) with ibudilast versus −0.03659 mm3/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 −0.4893 uM/year (−0.9132, −0.0654) with ibudilast versus −0.9587 uM/year (−1.3677, −0.5498) with placebo (n = 183, p = 0.12). Conclusion: 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. Trial registration: NN102/SPRINT-MS ClinicalTrials.gov number, NCT01982942.",
keywords = "Optical coherence tomography, ibudilast, multiple sclerosis, neuroprotection",
author = "Bermel, {Robert A.} and Fedler, {Janel K.} and Peter Kaiser and Cindy Novalis and Jeff Schneebaum and Klingner, {Elizabeth A.} and Dawn Williams and Yankey, {Jon W.} and Ecklund, {Dixie J.} and Marianne Chase and Naismith, {Robert T.} and Klawiter, {Eric C.} and Goodman, {Andrew D.} and Coffey, {Christopher S.} and Fox, {Robert J.}",
note = "Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by grants from the National Institute of Neurological Disorders and Stroke (NINDS) (grant no. U01NS082329) and the National Multiple Sclerosis Society (grant no. RG 4778-A-6) and by MediciNova through a contract with the National Institutes of Health (NIH). The NeuroNEXT Network is supported by the NINDS (Central Coordinating Center, U01NS077179; Data Coordinating Center, U01NS077352; and individual grants to each trial site). Funding Information: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: R.B. has served as a consultant for Biogen, Genzyme, Genentech, EMD Serono, Viela Bio, and Novartis. He receives research support from Biogen, Genentech, and Novartis, and shares rights to intellectual property underlying the Multiple Sclerosis Performance Test, currently licensed to Qr8 Health and Biogen. P.K. has received personal compensation from Carl Zeiss Medtec. R.T.N. has consulted for Alexion, Alkermes, Bayer AG, Biogen, Celgene, EMD Serono, Genentech, Genzyme, Novartis, TG Therapeutics, and Viela Bio. E.C.K. has received consulting fees from Alexion, Atlas5D, Biogen, Celgene, EMD Serono, Genentech, and MedDay and research funding from AbbVie, Atlas5D, Biogen, EMD Serono, Genzyme, and Roche. A.D.G. has received personal compensation for consulting from Adamas, EMD Serono, MedDay, Greenwich Bioscience, Celgene, Teva, Sun Pharma, Novartis, Sanofi Genzyme, Genentech-Roche, Biogen, Atara, and Acorda Therapeutics and received research support from Teva, Sun Pharma, Novartis, Sanofi Genzyme, Genentech-Roche, Biogen, Atara, and Acorda Therapeutics. K.N. has received personal licensing fee from Biogen, consulting fee from NeuroRx, and speaking fee from Sanofi Genzyme and research grant funding from Biogen, Novartis, and Sanofi Genzyme. R.J.F. has received personal consulting fees from Actelion, Biogen, Celgene, EMD Serono, Genentech, Immunic, Novartis, Sanofi Genzyme, Teva, and TG therapeutics; served on advisory committees for Actelion, Biogen, Immunic, and Novartis; and received clinical trial contract and research grant funding from Novartis. Publisher Copyright: {\textcopyright} The Author(s), 2020.",
year = "2021",
month = aug,
doi = "10.1177/1352458520964409",
language = "English",
volume = "27",
pages = "1384--1390",
journal = "Multiple Sclerosis",
issn = "1352-4585",
number = "9",
}