New Therapies and applications
Novel monoclonal antibody obexelimab demonstrates efficacy in phase 2 trial
Prof. Amit Bar-Or, University of Pennsylvania, PA, USA
Week 12 results from the phase 2 MoonStone trial provide the first clinical evidence supporting the efficacy of obexelimab, a novel humanised bifunctional monoclonal antibody, in patients with relapsing-remitting MS (RRMS). No new safety concerns arose from the study results.
GLP-1RAs are safe for MS patients but do not alter disease course
Dr Rachel Rodin, Harvard Medical School, MA, USA
In a small retrospective analysis, glucagon-like peptide-1 receptor agonists (GLP-1RAs) appeared to be safe for weight management in patients with MS, but no evidence was found for improvement in MS-related disability or biomarkers of disease activity and progression.
Remyelination
No remyelinating effects of bazedoxifene in postmenopausal MS patients
Dr Riley Bove, University of California San Francisco, CA, USA
In the placebo-controlled phase 2 ReWRap trial, bazedoxifene failed to demonstrate remyelinating effects in postmenopausal women with relapsing MS (RMS). The treatment was well tolerated, but no primary or secondary endpoints were met.
Nonetheless, the findings provide important insights for the design of future remyelinating trials.
Follow-up data and subgroup analyses
Dr Scott D. Newsome, Johns Hopkins University School of Medicine, Baltimore, MD
In approximately 9 of 10 treatment-naïve (TN) patients with relapsing MS (RMS) treated with ocrelizumab, either intravenous (IV) or subcutaneous (SC), no evidence of disease activity (NEDA-3) was maintained in any given year. Long-term safety data were reassuring, with infection rates decreasing over time and serious infection rates remaining low and stable.
New findings support ofatumumab as first-line therapy in early MS
Prof. Heinz Wiendl, University of Freiburg, Germany
A post-hoc analysis of the ASCLEPIOS I/II trials comparing ofatumumab with teriflunomide focused on newly diagnosed relapsing MS (RMS) patients with low disease activity. In this subgroup, ofatumumab was associated with >2-fold higher odds of remaining free of disease activity at 1 year and an 18-fold higher odds at 2 years.
Cladribine is associated with stable or improved cognition over 4 years in RMS
Prof. Bruno Brochet, University of Bordeaux, France
A pooled analysis of data from the extension of the CLARIFY-MS and MAGNIFY-MS studies assessed the long-term effects of cladribine on cognitive function in patients with relapsing MS (RMS). Results showed that most participants had stable or improved cognitive function, with clinically meaningful improvements or stability in cognitive processing speed (CPS) observed over 4 years.
Progressive MS
Tolebrutinib is not effective in PPMS in the PERSEUS trial
Dr Robert Fox, Cleveland Clinic, OH, USA
In the phase 3 PERSEUS trial, tolebrutinib did not meet the primary endpoint of time to onset of composite confirmed disability progression (cCDP) after 6 months. No significant differences compared with placebo were observed in any of the secondary disability endpoints. Safety findings were consistent with those from previous phase 3 trials of tolebrutinib.
Fenebrutinib is non-inferior to ocrelizumab in PPMS
Prof. Amit Bar-Or, University of Pennsylvania, PA, USA
In the randomised phase 3 FENtrepid trial, fenebrutinib was non-inferior to ocrelizumab at reducing the risk of disability progression in patients with primary progressive MS (PPMS). The oral Bruton tyrosine kinase inhibitor (BTKi) fenebrutinib significantly slowed disability progression.
NMOSD
Daratumumab is a promising novel treatment for NMOSD
Prof. Michael Levy, Massachusetts General Hospital, MA, USA
Daratumumab, a humanised monoclonal antibody targeting the CD38 glicoprotein, reduced the risk of relapse in patients with aquaporin-4 immunoglobulin G (AQP4-IgG) positive neuromyelitis optica spectrum disorder (NMOSD) in the phase 3 DAWN-trial.