The 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis – 24-26 September 2025
The following summarizes some of the highlights from Day 2 of ECTRIMS 2025.
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Ofatumumab – efficacy and safety at 7 years
Effect of tolebrutinib on PIRA
Canadian data on drug discontinuation
Breastfeeding reduces risk of pediatric MS
Neurofilament-light chain (NfL) predicts NEDA in RIS
Satralizumab real-world efficacy and safety in NMOSD
New treatments in development: Vidofludimus calcium
Clinical tip of the day
CONGRESS HIGHLIGHTS – FRIDAY EDITION
Ofatumumab – efficacy and safety at 7 years
Over 90% of MS patients achieve no evidence of disease activity (NEDA) in year 7 of treatment with ofatumumab, according to updated data from the ALITHIOS long-term extension study (n=1043) (Hauser et al. ECTRIMS 2025;P804). Participants were enrolled from the phase III ASCLEPIOS I/II trials of ofatumumab vs. teriflunomide (Hauser et al. N Engl J Med 2020;383:546-557). The annualized relapse rate remained low (0.128-0.023) for the continuous ofatumumab group in years 1-7; ARR in the teriflunomide group was low (0.065-0.048) in years 3-7 after switching to ofatumumab. Gadolinium-enhancing T1 lesions showed near-complete suppression in years 1-7 for the continuous ofatumumab group and from years 3-7 in the switch group. Almost complete suppression of new/enlarging T2 lesions was also seen in the continuous ofatumumab group in years 2-7 and in the switch group in years 4-7. IgG levels remained above the lower limit of normal in 96.8% of patients. The rate of infections or malignancies was stable during chronic ofatumumab exposure. Similar efficacy and safety results were reported for the subgroup (n=355) of recently-diagnosed and treatment-naïve patients (Bittner et al. ECTRIMS 2025;P805).
The rate of serious infections during long-term ofatumumab exposure (9258.2 patient-years) was reported separately (Ziemssen et al. ECTRIMS 2025;P812). The most common serious infections were COVID-19 (2.59%), urinary tract infection (1.02%), non-COVID respiratory tract infection (0.96%), and appendicitis (0.76%). The annualized rate of serious infections was stable throughout the exposure period (0.013 in year 1, 0.023 in year 7).
Effect of tolebrutinib on PIRA
The recently-published GEMINI I/II trials of tolebrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, found no significant difference in annualized relapse rate in RMS patients treated with tolebrutinib 60 mg/day or teriflunomide 14 mg/day (Oh et al. N Engl J Med 2025;392:1893-1904). However, the pooled rate of 6-month confirmed disability progression was lower with tolebrutinib (8.3% vs. 11.3%). Almost 80% of CDP events were progression independent of relapse activity (PIRA), according to a new analysis of the GEMINI trials (Oh et al. ECTRIMS 2025;P794). Fewer patients in the tolebrutinib vs. teriflunomide group experienced a PIRA event (6.4% vs. 8.5%); PIRA risk reduction was 27%.
Canadian data on drug discontinuation
The Calgary MS clinic conducted a follow-up analysis of patients aged ≥60 years who discontinued treatment with a DMT during the period 2015-2020 (n=71) (Gutierrez et al. ECTRIMS 2025;P817). Mean age was 65 years; mean duration of treatment was 10.32 years; mean follow-up was 4.6 years. Patients were receiving interferon-beta (n=25), glatiramer acetate (n=28), dimethyl fumarate (n=5), fingolimod (n=5), minocycline (n=2) and teriflunomide (n=6). Patients on anti-CD20 agents were excluded from the analysis. Overall, 55% had no disease activity in the five years prior to discontinuation, 21% had a relapse and/or new MRI lesion, and 24% had suspected SPMS. The most common reasons for discontinuation were disease stability or transition to SPMS. At the end of the five-year follow-up, 48% had no new disease activity and 39% had SPMS. There were five deaths from non-MS-related causes.
Breastfeeding reduces risk of pediatric MS
Breastfeeding appears to significantly reduce the risk of pediatric-onset MS, according to results from the Pediatric Italian Genetic and Environment Exposure (PEDIGREE) Study (Pilotto et al. ECTRIMS 2025;P656). A total of 96 pediatric MS cases and 96 controls completed questionnaires to provide perinatal and environmental data. Breastfeeding was categorized as ‘reference’ if was maintained ≥4 months, ‘reduced’ if ≤3 months, or absent. Patients with absent or reduced breastfeeding had a higher risk of developing MS compared to patients in the reference group (odds ratio 2.04). The risk with absent/reduced breastfeeding was higher if the reference used was exclusive breastfeeding (OR 2.54). The authors concluded that prolonged breastfeeding may have a protective role in early immune development.
Neurofilament-light chain (NfL) predicts NEDA in RIS
Baseline levels of serum neurofilament-light chain (sNfL) are significant predictors of no evidence of disease activity (NEDA) in individuals with radiologically isolated syndrome (RIS), according to a new study at the BARLO MS Centre (Schneider et al. ECTRIMS 2025;P1532). The study involved 48 treatment-naïve RIS patients. In contrast, baseline glial fibrillary acidic protein (GFAP) levels were not predictive of NEDA and did not add prognostic value when combined with sNfL values.
Satralizumab real-world efficacy and safety in NMOSD
A single-centre study in Germany examined the real-world effectiveness of satralizumab, an anti-IL6 receptor inhibitor, in 54 patients with neuromyelitis optica spectrum disorders (NMOSD) (Mehl et al. ECTRIMS 2025;P869). Median age was 52 years; median time from diagnosis to satralizumab initiation was 5.9 years. After treatment start, the annualized attack rate significantly decreased from 1.168 to 0.121. Adverse effects included mild-to-moderate elevations in liver enzymes (31%), elevated serum lipids (38%) and cytopenia (18%). The continuation rate at one year was 85%.
New treatments in development: Vidofludimus calcium
Vidofludimus calcium is an inhibitor of the mitochondrial enzyme dihydroorotate dehydrogenase (DHODH) and activator of the neuroprotective transcription factor nuclear receptor-related 1 (Nurr1). In the phase II EMPHASIS study, vidofludimus calcium was superior to placebo in reducing the cumulative number of combined unique lesions (CUA) at 24 weeks (rate ratio vs. placebo 0.38 with 45 mg/day, 0.30 with 30 mg/day) (Fox et al. Ann Clin Transl Neurol 2022l;9:977-987). Serum NfL was reduced in a dose-dependent manner (Fox et al. Neurol Neuroimmunol Neuroinflamm 2024;11:e200208).
For the open-label extension, patients received vidofludimus calcium 30 mg or 45 mg/day; the higher-dose group was subsequently switched to 30 mg/day (Fox et al. ECTRIMS 2025;P814). At week 144, 92.7% had no 24-week confirmed disability worsening; 13.8% of CDW events were PIRA. The most common adverse effects were COVID-19 (9.4%), nasopharyngitis (5.9%), backpain (5.1%), and headache (4.7%) (Fox et al. ECTRIMS 2025;P834). Renal and hepatic adverse events occurred in 3.5%/year and 3.1%/year of patients, respectively. The phase III ENSURE-1 and ENSURE-2 trials are ongoing.
Clinical tip of the day
Routine monitoring with spinal-cord MRI is not required even in patients with spinal cord lesions, according to five-year retrospective study (Hong et al. ECTRIMS 2025;O143). New cord lesions occurred in only 2% of patients without relapses or new brain lesions. The time to disability progression was similar in patients with new cord lesions vs. new brain lesions.
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