July 2022 
- An off-label drug may be an effective alternative to approved treatments for multiple sclerosis (MS).
- Federal approval is unlikely, but off-label use will probably remain a viable option.
- The cost of MS treatment is generally high and this drug could be more affordable.
It’s understandable to have a lot on your mind when you’re diagnosed with multiple sclerosis (MS).
The cost of treatment shouldn’t be one of those things. However, drugs used to treat MS are notoriously expensive.
According to new research from Sweden, pricing relief might be found by treating MS with an off-label drug called rituximab.
Researchers add that rituximab might even be more effective than some MS treatments already approved by the Food and Drug Administration (FDA).
Where does rituximab fit in?
There’s no shortage of options for treating RRMS.
“There are currently almost two dozen disease-modifying therapies that are approved for use in the U.S. that are indicated for treatment of RRMS,” said Giesser.
One of these drugs is dimethyl fumarate.
What’s not on the list of FDA-approved RRMS treatments? Rituximab.
Researchers wanted to know how well rituximab prevented relapses compared to dimethyl fumarate. Their study included 195 people who had been newly diagnosed with RRMS. These participants were randomly assigned to receive either rituximab or dimethyl fumarate for 24 months.
The researchers said they found rituximab to be the superior treatment. In fact, those receiving rituximab had a 5-fold lower risk of relapse than those receiving dimethyl fumarate. Further, MRI scans showed fewer MS plaques in people who took rituximab. There also wasn’t an increased risk of side effects when rituximab was used.
The researchers also noted that rituximab is more affordable.
The research was funded by the Swedish Research Council, but some of the study authors reported potential conflicts of interest with pharmaceutical companies involved with rituximab.
Nonetheless, the outside experts interviewed by Healthline agreed with the study’s conclusions.
“There are a lot of different versions of dimethyl fumarate now. They’re very expensive and it’s a very simple compound, so it defies logic that it’s so expensive,” said Sicotte.
“In some circumstances, rituximab is the preferred treatment over the FDA-approved versions because it is so much cheaper to use,” she added.
Rituximab was originally developed for lymphoma and has since been used for other autoimmune diseases.
“It was tested in RRMS 10 years ago and it was a paradigm breaker. It worked to decrease relapses effectively, and that really opened the door to a new class of medications for MS, including ocrelizumab and ofatumumab,” Sicotte said.
The future of RRMS treatment
If rituximab is indeed more effective and less costly than some other RRMS treatments, why doesn’t it have FDA approval for RRMS?
“The cost for doing the large study required to formally prove that rituximab is effective wouldn’t be cost-effective for the pharmaceutical companies. Biosimilar generic versions of rituximab are available now, so it’s very unlikely that anyone will pursue FDA approval,” Sicotte explained.
This doesn’t mean that you can’t use rituximab to treat RRMS. It just means that coverage will vary from one insurance policy to another.
There are also other available options.