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Clinical trial yields fewer relapses in multiple sclerosis patients treated with off-label drug (1/5th the relapses with Rituximab)
Medical Xpress / Karolinska Institutet / The Lancet Neurology ^ | July 13, 2022 | Anders Svenningsson et al

Posted on 07/14/2022 10:17:47 AM PDT by ConservativeMind

Patients with multiple sclerosis (MS) treated with the drug rituximab had a significantly lower risk of relapse compared with MS patients receiving standard treatment. 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 trial is a study involving patients 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 that those who received rituximab had fewer new MS plaques, i.e., 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 make it an attractive first choice," says Anders Svenningsson.

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 marketing rights to apply for a new indication. But now, in addition to accumulated clinical experience, we also have the documentation usually required to apply for an indication," says Anders.

(Excerpt) Read more at medicalxpress.com ...


TOPICS: Health/Medicine
KEYWORDS: rituximab
This simple additional drug could make a big difference for MS sufferers.
1 posted on 07/14/2022 10:17:47 AM PDT by ConservativeMind
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To: Pete from Shawnee Mission; Mazey; ckilmer; goodnesswins; Jane Long; BusterDog; jy8z; ...

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2 posted on 07/14/2022 10:18:12 AM PDT by ConservativeMind (Trump: Befuddling Democrats, Republicans, and the Media for the benefit of the US and all mankind.)
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To: ConservativeMind

Rituximab is used for cancer chemo.


3 posted on 07/14/2022 10:26:41 AM PDT by BenLurkin (The above is not a statement of fact. It is either opinion, or satire, or both.)
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To: ConservativeMind

Abstract of the paper here:

https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(22)00209-5/fulltext

Upside is that it is cheap and effective, downside is it need to be administered via IV.


4 posted on 07/14/2022 10:30:46 AM PDT by Wayne07
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To: ConservativeMind

Rituxan is expensive and it requires a one on one IV administration, such are the severity of possible side effects.....


5 posted on 07/14/2022 10:38:33 AM PDT by cherry (;)
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