Clinical trial yields fewer relapses in multiplesclerosis patients treated with off-label drug TheLancet
Patients with multiple sclerosis 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. 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 or standard dimethyl fumarate treatment. During the 24-month follow-up, the occurrence of relapses, i.e., a temporary deterioration of the disease state, was investigated..
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 3 clinical trials. However, the drug has been shown to have a good effect on relapsing-remitting MS and is therefore 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.
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