There is no approved disease-modifying therapy for naSPMS, said Nadine Ehrhardt (University of Augsburg, Germany). Rituximab is sometimes prescribed off-label. Studies addressing the efficacy of this B-cell depleting therapy in naSPMS are lacking. Therefore, Ehrhardt and colleagues conducted a retrospective multicentre study to evaluate the efficacy and safety of rituximab in participants with naSPMS [1]. They included 46 naSPMS participants who received rituximab for at least 6 months. The total observational period was up to 5 years, starting 24 months before rituximab treatment, and including up to 36 months after the start of treatment.
The 46 participants had a mean age of 49.5 years at the start of treatment and were predominantly male (59%). Mean age at MS manifestation was 29.5 years; mean time since naSPMS onset was 4.72 years. The Expanded Disability Status Scale (EDSS) score at the start of rituximab treatment was 5.45. There was a significant increase in EDSS to 6 (IQR 4.38-6.5; p=0.046; n=34) after 18 months, and also after 36 months (IQR 4.5-6.5; p=0.029; n=24) compared to baseline. Maximum walking distance was significantly reduced (by 24 meters) already 24 months before rituximab treatment (p=0.018), and remained reduced 36 months after the start of treatment (p=0.233). After between 6 and 30 months of treatment, 6 participants showed MRI disease activity.
The most common side-effects were infusion-related reactions (15%), urinary tract infections (11%) and respiratory tract infections (6.5%). There was 1 malignancy. Of the participants who withdrew from treatment, 33% did so because of inefficacy and 22% due to comorbidities.
- Ehrhardt N, et al. Effect of rituximab on non-active secondary progressive multiple sclerosis – a retrospective multicenter analysis. OPR-080, EAN Congress 2025, 21-24 June 2025, Helsinki, Finland.
Medical writing support was provided by Michiel Tent.
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