MS News Notes: Briumvi, vitamin D, CNM-Au8
Columnist Ed Tobias comments on the week's top MS news
Welcome to “MS News Notes,” a Monday morning column in which I comment on multiple sclerosis (MS) news stories that caught my eye last week. In this column, I’ll be highlighting more MS News Today articles from the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) forum, held Feb. 23-25 virtually and in San Diego. Here’s a look at what’s been happening:
The Briumvi buzz is encouraging
Briumvi (ublituximab-xiiy) is the newest of the disease-modifying therapies (DMTs) approved by the U.S. Food and Drug Administration (FDA) to reduce relapses and slow the development of brain lesions in people with relapsing forms of MS. It’s a B-cell-depleting treatment that’s similar to Ocrevus (ocrelizumab), but at a lower dose, so the infusion time is one hour, every six months.
An analysis presented at ACTRIMS and reported by Marisa Wexler in “ACTRIMS 2023: Most on Briumvi show no MS activity after 6 months” shows that the medication is holding MS in check for most people being treated with it. In the first six months after starting Briumvi in the ULTIMATE clinical trials, more than half (53.4%) of patients had no evidence of disease activity (NEDA-3). Most of the patients who achieved NEDA-3 in the first six months continued to have no evidence of disease activity over the duration of the two-year studies.
Briumvi was approved by the FDA late last year. It became available on the market in January.
Briumvi expected to cost less than other DMTs
Here’s some exciting news: TG Therapeutics, the developer of Briumvi, has priced the treatment at $59,000 a year, which the company says is the lowest price for any branded MS therapy on the market. That’s about 25% below the cost of most of those medications, which two years ago were reported to be about $80,000 a year.
In the MS News Today article “ACTRIMS 2023: TG aims to make Briumvi accessible to patients,” Wexler quotes TG’s CEO, Michael Weiss, as giving two reasons for this pricing: “One is just benefiting society generally, and two, permitting as quick access as possible to patients.” If TG can set a price at this level, why can’t other big pharmaceutical companies do the same?
High-dose vitamin D may not alter MS course
There’s been a lot of talk over the years about the possible benefits of vitamin D, both to prevent MS and to reduce its progression. But a study presented at ACTRIMS 2023 casts doubt on its ability to curb progression.
“ACTRIMS 2023: High-dose vitamin D doesn’t reduce MS activity: Trial” reports on a Johns Hopkins University clinical trial that followed 139 people with relapsing-remitting MS, ages 18 to 50, who were being treated with glatiramer acetate (sold as Copaxone and its generics).
Some had 600 International Units (IU)/day of vitamin D added to their DMT, and others had 5,000 IU/day. After two years, researchers found no statistically significant difference between the high- and low-dose groups regarding new or enlarging lesions, active inflammatory lesions, or rates of brain atrophy. There were also no significant differences in relapse activity or disability progression.
The researchers say they expect the results would be the same if vitamin D were used to supplement other DMTs. It makes me wonder if I should toss out the 5,000 IUs of vitamin D that I’ve been taking for many years.
CNM-Au8, aimed at progressive MS, to enroll study participants
CNM-Au8 is an experimental oral liquid that uses a suspension of gold nanoparticles that are designed to boost energy production in cells. By doing that, it’s believed the cells can be made to better withstand diseases.
Earlier studies have reported that the use of CNM-Au8 led to improvements in vision, cognitive and motor function, and brain health of people with MS. Now, as Wexler reports in “ACTRIMS 2023: CNM-Au8 bound for Phase 3 testing after positive data,” Clene Nanomedicine is getting ready to launch a global Phase 3 clinical trial of that medication.
While most studies of MS treatments are designed for people with relapsing-remitting MS, this study will most likely enroll people with primary progressive or secondary progressive (SPMS) disease who haven’t had a relapse in at least a year. That’s exciting news for people like me, with nonactive SPMS, as we’re often overlooked when new DMTs are being created.
Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to multiple sclerosis.
Like you, I also have spms, although I have recently progressed to ppms. Love to be in this trial for cam-Au8. Sounds exciting and promising. Very few clinical trials for us old timers. Another good one Ed. Thanks from West by God Virginia
I hope you give it a shot and are accepted. If you are, may the treatment work well for you. BTW, I don't know what part of WV you're in but my wife and I spend about half of the year in Maryland and we love to drive up to Shepardstown to visit the restaurants and shops.
Ronald T Crooker
5,000 IU's of vitamin D3 is not a very high dose. Look at the levels the Coimbra Protocol recommends 50,000 to 1000,000 IU's then you may have a true perspective on what a high dose of vitamin D3 can or cannot do. 5,000 IU's I consider a regular daily dose.
Thanks for your comment. You're right, 5,000 IUs is not a very high dose. It's interesting that this study didn't use a higher dose and I wonder why they didn't choose one that was much higher.
Mon médecin n'arrête pas de me dire que les fortes doses de vitamine D faisait monter la créatinine et qu'un fort taux de créatinine était dommageable pour les reins. Après 2 épisodes intense de pierres aux reins, je ne sais plus trop quoi en penser.
My doctor keeps telling me that high doses of vitamin D raise creatinine and that high creatinine is damaging to the kidneys. After 2 intense episodes of kidney stones, I don't know what to think anymore.
Bonjour Marc - Je pense que la question est de savoir ce que votre médecin considère comme un niveau "élevé" de vitamine D. J'en discuterais avec lui et je verrais si une dose plus faible pourrait vous être utile.
Hello Marc - I think the question is what your doctor considers to be a "high" level of vitamin-D. I would discuss that with him or her and see if a lower dose might be useful to you.
The conclusion regarding the uselessness of high dose Vitamin D supplementation may lead people to infer that no Vitamin D supplementation would be helpful. It's important to remember that in the study even the control group received 600 IU of Vitamin D so while high doses may not make a difference ensuring minimal levels may still be helpful.
Thanks for pointing that out.