Rituximab does not halt progression in non-active secondary progressive MS

In an observational study, treatment with rituximab could not fully prevent the progression of non-active secondary progressive multiple sclerosis (naSPMS). There was a slight but significant increase in disability. The treatment was generally well-tolerated and considered safe.

naSPMS is characterised by a steady increase in disability without relapses or MRI activity. “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. Baseline characteristics, disability progression before and during treatment, MRI activity and safety were analysed.

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). Patients with MRI activity within 6 months before treatment start were excluded from the study to meet the naSPMS definition. 6 participants showed MRI disease activity between 6 and 30 months from treatment start, 3 between 18 and 6 months prior to treatment start.

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, the other because of AEs, patient decision or other causes.

1. 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, Helsinki, Finland.

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Posted on 3 September 2025