The phase 3 clinical trial was a multicenter study including 195 patients from 17 hospitals in Sweden newly diagnosed with the most common form of MS, relapsing-remitting MS. Patients were randomized to standard rituximab (Mabthera) or dimethyl fumarate (Tecfidera). During 24 months of follow-up, the occurrence of relapses, i.e. transient worsening of the disease, was investigated.
5 times lower risk of relapse
Results showed that those treated with rituximab had a 5-fold lower risk of relapse. Only 3 of 98 patients who received rituximab experienced a relapse, compared with 16 of 97 patients who received dimethyl fumarate. Magnetic resonance imaging (MRI) also showed that people who received rituximab had fewer new MS plaques, which are areas of damage or scarring in the central nervous system. No increased risk of side effects with rituximab was observed.
“The excellent efficacy and low cost of rituximab could make it an attractive first choice for newly diagnosed MS patients, especially in resource-poor areas. But more large studies are needed to confirm the drug’s effectiveness, long-term safety, and cost-effectiveness for MS,” said the study’s first author. Anders Svenningssonadjunct professor at Department of Clinical Sciences, Danderyd . HospitalKarolinska Institutet and chief physician at the neurology clinic at Danderyd Hospital.
Rituximab is used for various medical conditions but is not approved to treat MS because of the lack of data from phase 3 clinical trials. However, the drug has been shown to work well for MS. recurrent MS. As a result, this medication is often prescribed off-label, meaning that only the treating physician is responsible for the treatment.
A necessary step to get approved
“Since the patent has expired, there is no incentive from the pharmaceutical company that holds the marketing rights to apply for a new designation. But now, in addition to our accumulated clinical experience, we also have the documents that are usually required to register the indication. Our study is an important step towards rituximab becoming an approved MS drug,” said Anders Svenningsson.
Source: Karolinska Institutet
