Faculty Collaboration Database

Effects of Ibudilast on MRI Measures in the Phase 2 SPRINT-MS Study. Neurology 2021 Jan 26;96(4):e491-e500

Date

12/04/2020

Pubmed ID

33268562

Pubmed Central ID

PMC7905793

DOI

10.1212/WNL.0000000000011314

Scopus ID

2-s2.0-85100445479 (requires institutional sign-in at Scopus site)   27 Citations

Abstract

OBJECTIVE: To determine whether ibudilast has an effect on brain volume and new lesions in progressive forms of multiple sclerosis (MS).

METHODS: 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.

RESULTS: 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 (p = 0.82). New T1 hypointense lesions at 96 weeks were observed in 33.3% on ibudilast and 23.5% on placebo (p = 0.11). Gray matter atrophy was reduced by 35% for those on ibudilast vs placebo (p = 0.038). Progression of whole brain atrophy by SIENA was slowed by 20% in the ibudilast group compared with placebo (p = 0.08).

CONCLUSION: 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.

CLASSIFICATION OF EVIDENCE: 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.

Author List

Naismith RT, Bermel RA, Coffey CS, Goodman AD, Fedler J, Kearney M, Klawiter EC, Nakamura K, Narayanan S, Goebel C, Yankey J, Klingner E, Fox RJ, SPRINT-MS investigators

Author

Ahmed Zayed Obeidat MD, PhD Associate Professor in the Neurology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Aged
Female
Humans
Magnetic Resonance Imaging
Male
Middle Aged
Multiple Sclerosis
Phosphodiesterase Inhibitors
Pyridines
Treatment Outcome