People with multiple sclerosis (MS) treated with the drug rituximab during a clinical trial showed a five-fold lower risk of relapse, results show.
The phase three trial involved 195 patients from 17 hospitals in Sweden, newly diagnosed with relapsing remitting MS.
Patients were given either rituximab – also known as Rituxan or Mabthera – or standard dimethyl fumarate treatment.
During the 24-month follow-up, the occurrence of relapses was investigated.
The results showed that those treated with rituximab had a five-fold lower risk of relapse, with only three out of 98 patients who received rituximab having relapses, compared to 16 out of 97 patients who received dimethyl fumarate.
MRI scans also showed that those who received rituximab had fewer new MS plaques showing areas of damage or scarring in the central nervous system. No increased risk of adverse 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, not least in resource-poor areas,” says study first author Anders Svenningsson, adjunct professor at the Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet and chief physician at the neurology clinic at Danderyd Hospital.
“But more and larger studies are needed to confirm the drug’s efficacy, long-term safety and cost-effectiveness for MS.”
Rituximab is used for a variety of medical conditions but is not approved for the treatment of MS because there has been a lack of data from phase three clinical trials.
However, the drug has been shown to have a good effect on relapsing remitting MS and is often prescribed ‘off label’, which means that the treating doctor alone assumes responsibility for the treatment.
“Since the patent has expired, there is no incentive from the pharmaceutical company holding the marketing rights to apply for a new indication. But now, in addition to accumulated clinical experience, we also have the documentation that is usually required to apply for an indication,” says Anders Svenningsson.
“Our study is an important step on the way for rituximab to become an approved MS drug.”
