Effects of Ibudilast on MRI Measures in the Phase 2 SPRINT-MS Study
| Autor: | Sprint-Ms investigators, Sridar Narayanan, Christopher Goebel, Marianne Kearney, Robert J. Fox, Christopher S. Coffey, Elizabeth A. Klingner, Andrew D Goodman, Robert T Naismith, Kunio Nakamura, Jon Yankey, Eric C. Klawiter, Janel Fedler, Robert A. Bermel |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Multiple Sclerosis Phosphodiesterase Inhibitors Pyridines Clinical Trials and Supportive Activities Clinical Sciences Ibudilast Neurodegenerative Placebo Gastroenterology 03 medical and health sciences 0302 clinical medicine Atrophy Clinical Research Internal medicine Secondary analysis medicine Humans 030212 general & internal medicine Secondary progressive SPRINT-MS investigators Aged Neurology & Neurosurgery business.industry Multiple sclerosis Neurosciences Evaluation of treatments and therapeutic interventions Middle Aged medicine.disease Magnetic Resonance Imaging Brain Disorders Treatment Outcome 6.1 Pharmaceuticals Brain size Neurological T2 lesions Biomedical Imaging Cognitive Sciences Female Neurology (clinical) business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Neurology, vol 96, iss 4 |
| ISSN: | 1526-632X |
| Popis: | ObjectiveTo determine whether ibudilast has an effect on brain volume and new lesions in progressive forms of multiple sclerosis (MS).MethodsA 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.ResultsA 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).ConclusionIbudilast 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 EvidenceThis study provides Class II evidence that for people with MS, ibudilast does not significantly reduce new or enlarging T2 lesions or new T1 lesions. |
| Databáze: | OpenAIRE |
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