Journal article
Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis
Multiple sclerosis, Vol.27(9), pp.1352458520964409-1390
10/15/2020
DOI: 10.1177/1352458520964409
PMCID: PMC8046841
PMID: 33054533
Abstract
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.
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 +0.0424 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 (
= 244,
= 0.22). Macular volume change was -0.00503 mm
/year (-0.02693 to 0.01688) with ibudilast versus -0.03659 mm
/year (-0.05824 to -0.01494) for placebo in the Spectralis cohort (
= 61,
= 0.044). For the Cirrus cohort, macular volume change was -0.00040 mm
/year (-0.02167, 0.020866) with ibudilast compared to -0.02083 mm
/year (-0.04134 to -0.00033) for placebo (
= 183,
= 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 (
= 183,
= 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.
Details
- Title: Subtitle
- Optical coherence tomography outcomes from SPRINT-MS, a multicenter, randomized, double-blind trial of ibudilast in progressive multiple sclerosis
- Creators
- Robert A Bermel - Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USAJanel K Fedler - University of Iowa, BiostatisticsPeter Kaiser - Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USACindy Novalis - Digital Angiography Reading Center, Great Neck, NY, USAJeff Schneebaum - Digital Angiography Reading Center, Great Neck, NY, USAElizabeth A Klingner - Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USADawn Williams - University of Iowa, Physical Therapy and Rehabilitation ScienceJon W Yankey - Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City, IA, USADixie J Ecklund - University of IowaMarianne Chase - Clinical Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), Massachusetts General Hospital, Harvard Medical School, Boston, MA, USARobert T Naismith - Department of Neurology, Washington University, St. Louis, MI, USAEric C Klawiter - Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USAAndrew D Goodman - Department of Neurology, University of Rochester Medical Center, Rochester, NY, USAChristopher S Coffey - University of Iowa, BiostatisticsRobert J Fox - Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA
- Resource Type
- Journal article
- Publication Details
- Multiple sclerosis, Vol.27(9), pp.1352458520964409-1390
- DOI
- 10.1177/1352458520964409
- PMID
- 33054533
- PMCID
- PMC8046841
- NLM abbreviation
- Mult Scler
- ISSN
- 1352-4585
- eISSN
- 1477-0970
- Grant note
- U01 NS082329 / NINDS NIH HHS U24 NS107156 / NINDS NIH HHS U01 NS077352 / NINDS NIH HHS U01 NS077179 / NINDS NIH HHS U24 NS107205 / NINDS NIH HHS
- Language
- English
- Date published
- 10/15/2020
- Academic Unit
- Biostatistics
- Record Identifier
- 9984131868602771
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