Journal article
Effects of Ibudilast on MRI Measures in the Phase 2 SPRINT-MS Study
Neurology, Vol.96(4), pp.e491-e500
01/26/2021
DOI: 10.1212/WNL.0000000000011314
PMCID: PMC7905793
PMID: 33268562
Abstract
To determine whether ibudilast has an effect on brain volume and new lesions in progressive forms of multiple sclerosis (MS).
A randomized, placebo-controlled, blinded study evaluated ibudilast at a dose of up to 100 mg over 96 weeks in primary and secondary progressive MS. In this secondary analysis of a previously reported trial, secondary and tertiary endpoints included gray matter atrophy, new or enlarging T2 lesions as measured every 24 weeks, and new T1 hypointensities at 96 weeks. Whole brain atrophy measured by structural image evaluation, using normalization, of atrophy (SIENA) was a sensitivity analysis.
A total of 129 participants were assigned to ibudilast and 126 to placebo. New or enlarging T2 lesions were observed in 37.2% on ibudilast and 29.0% on placebo (
= 0.82). New T1 hypointense lesions at 96 weeks were observed in 33.3% on ibudilast and 23.5% on placebo (
= 0.11). Gray matter atrophy was reduced by 35% for those on ibudilast vs placebo (
= 0.038). Progression of whole brain atrophy by SIENA was slowed by 20% in the ibudilast group compared with placebo (
= 0.08).
Ibudilast treatment was associated with a reduction in gray matter atrophy. Ibudilast treatment was not associated with a reduction in new or enlarging T2 lesions or new T1 lesions. An effect on brain volume contributes to prior data that ibudilast appears to affect markers associated with neurodegenerative processes, but not inflammatory processes.
This study provides Class II evidence that for people with MS, ibudilast does not significantly reduce new or enlarging T2 lesions or new T1 lesions.
Details
- Title: Subtitle
- Effects of Ibudilast on MRI Measures in the Phase 2 SPRINT-MS Study
- Creators
- Robert T Naismith - Washington University in St. LouisRobert A Bermel - Cleveland ClinicChristopher S Coffey - University of IowaAndrew D Goodman - University of RochesterJanel Fedler - University of IowaMarianne Kearney - Massachusetts General HospitalEric C Klawiter - Massachusetts General HospitalKunio Nakamura - Cleveland ClinicSridar Narayanan - McGill UniversityChristopher Goebel - Cleveland ClinicJon Yankey - University of IowaElizabeth Klingner - University of IowaRobert J Fox - Cleveland ClinicSPRINT-MS investigators
- Resource Type
- Journal article
- Publication Details
- Neurology, Vol.96(4), pp.e491-e500
- DOI
- 10.1212/WNL.0000000000011314
- PMID
- 33268562
- PMCID
- PMC7905793
- NLM abbreviation
- Neurology
- ISSN
- 0028-3878
- eISSN
- 1526-632X
- Grant note
- U01 NS082329 / NINDS NIH HHS U01 NS077352 / NINDS NIH HHS U24 NS107182 / NINDS NIH HHS U01 NS077179 / NINDS NIH HHS U24 NS107205 / NINDS NIH HHS
- Language
- English
- Date published
- 01/26/2021
- Academic Unit
- Biostatistics
- Record Identifier
- 9984214696302771
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