Clinical trial yields fewer relapses in multiple sclerosis patients treated with off-label drug

Patients with multiple sclerosis (MS) treated with the drug rituximab had a significantly lower risk of relapse compared with MS patients receiving standard treatment. This has been shown in a phase 3 clinical trial by researchers at Karolinska Institutet and Danderyd Hospital in Sweden published in The Lancet Neurology. Rituximab is not approved as an MS drug, but has proven to be effective in smaller studies and is therefore largely prescribed “off label.”

The Phase 3 clinical trial is a multi-center study involving 195 patients from 17 hospitals in Sweden who were newly diagnosed with the most common form of MS, relapsing-remitting MS. Patients were randomly given either rituximab (Mabthera) or standard dimethyl fumarate (Tecfidera) treatment. During the 24-month follow-up, the occurrence of relapses, i.e., a temporary deterioration of the disease state, was investigated.

The results showed that those treated with rituximab had a five-fold lower risk of relapse. Only three out of 98 patients who received rituximab suffered relapses, compared to 16 out of 97 patients who received dimethyl fumarate. Magnetic resonance imaging (MRI) also showed…

Medical Xpress. (2022, July 13). Clinical trial yields fewer relapses in multiple sclerosis patients treated with off-label drug

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