The effect of ibudilast on thalamic volume in progressive multiple sclerosis

• Published in: Multiple sclerosis 2023-12, Vol.29 (14), p.1819-1830
• Main Authors: Nicholson, Showly, Russo, Andrew W, Brewer, Kristina, Bien, Heidi, Tobyne, Sean M, Eloyan, Ani, Klawiter, Eric C
• Format: Article
• Language: English
• Subjects: Anisotropy; Atrophy; Atrophy - drug therapy; Bayes Theorem; Bayesian analysis; Cognitive ability; Humans; Multiple sclerosis; Multiple Sclerosis - diagnostic imaging; Multiple Sclerosis - drug therapy; Multiple Sclerosis, Chronic Progressive - diagnostic imaging; Multiple Sclerosis, Chronic Progressive - drug therapy; Placebos; Thalamus
• ISSN: 1352-4585; 1477-0970; 1477-0970
• DOI: 10.1177/13524585231204710

Background: Thalamic volume loss is known to be associated with clinical and cognitive disability in progressive multiple sclerosis (PMS). Objective: To investigate the treatment effect of ibudilast on thalamic atrophy more than 96 weeks in the phase 2 trial in progressive(MS Secondary and Primary Progressive Ibudilast NeuroNEXT Trial in Multiple Sclerosis [SPRINT-MS]). Methods: A total of 231 participants were randomized to either ibudilast (n = 114) or placebo (n = 117). Thalamic volume change was computed using Bayesian Sequence Adaptive Multimodal Segmentation tool (SAMseg) incorporating T1, fluid-attenuated inversion recovery (FLAIR), and fractional anisotropy maps and analyzed with a mixed-effects repeated-measures model. Results: There was no significant difference in thalamic volumes between treatment groups. On exploratory analysis, participants with primary progressive multiple sclerosis (PPMS) on placebo had a 0.004% greater rate of thalamic atrophy than PPMS participants on ibudilast (p = 0.058, 95% confidence interval (CI) = −0.008 to