MS Research Spotlight: Young Donor Blood Scam, MS Dementia, & More

MS Research Spotlight covers key research news from the last month.

Questionable science alert

Back in February, the US Food & Drug Administration (FDA) offered an advisory calling out questionable claims made by unnamed clinics offering treatments of “young donor” plasma which promised to remedy a wide range of concerns, from simple aging to PTSD to—you guessed it—MS.^1,2

In Jann Bellamy’s commentary at Science-Based Medicine, Bellamy named Ambrosia Health as the company at the center of this controversy. Apparently, it sold plasma from donors between the ages of 16 and 25 up until the FDA issued its advisory. Prices ran from $8,000 for one liter to $12,000 for two liters).

Ambrosia conducted previous clinical trials which ended in January 2018. They have since been the subject of ethics inquiries and claims of unprofessional conduct. Safety concerns among trial subjects, several who experienced significant side effects, have also been reported.¹

MS “dementia” isn’t something to worry about, researchers say

Many people diagnosed with MS worry about loss of cognitive function, and for good reason. Cognitive impairment is one of many symptoms of the disease.

However, this paper’s authors—Katsari, et al.—question a trend referencing something called “MS dementia.” They share that scientific literature provides no conclusive evidence that any such symptom occurs as a part of MS's progressive decline.³

Instead, Katsari et al. points to the many different factors that influence the course of cognitive decline in MS. These include disability severity, type of MS, depression as a comorbid concern, fatigue severity, and other factors.³

Katsari, et al. conclude: “There is no robust evidence allowing us to corroborate the idea of MS resulting in inevitable cognitive decline with advancing age. Therefore, we must remain skeptical against the emerging trend of ‘MS Dementia.’”³

Clinical trial looking for people with MS who do not use DMTs

People with MS and their healthcare specialists have long wanted to know whether starting an intense disease-modifying therapy (DMT) treatment upon diagnosis of MS improves its prognosis.

Not every person with MS wishes to start using DMTs right out of the gate. For this reason, the researchers behind the DELIVER-MS study plan to perform a three-year analysis. It will include 800 patients from two dozen MS centers in both the UK and the US to settle this open debate.⁴

Researchers seek subjects under the age of 55 who have experienced symptoms within the last five years and have not used any DMTs.

The clinicians hope that “data from DELIVER-MS study will help weigh up the potential benefits and risks of starting treatment with highly effective DMTs. The data will help develop guidance for patients and neurologists on the use of existing and new treatments.”⁴

Another oral treatment for MS on the horizon?

A new drug application will be reviewed by both the US FDA and the European Medicines Agency as a potential new oral treatment for people with RRMS. Ozanimod is a drug currently undergoing testing in two current late-stage studies (SUNBEAM and RADIANCE).

If approved, the drug, manufactured by Celgene, could be available as soon as March 2020 in the US or by June of next year in Europe.⁵

The drug is also being developed for use in Crohn’s disease and ulcerative colitis.

Stay tuned!

Global cohort of African subjects finds positive gains with ongoing Tecfidera study

At Seattle’s Consortium of Multiple Sclerosis Centers (CMSC) meeting in May, reports from a new study (ESTEEM) determined Tecfidera (dimethyl fumarate) to be safe and effective for use by African-American and black patients with RRMS.⁶

The research findings are significant: many clinical trials do not focus on subjects who are primarily African American, said Dr. Mitzi Williams at the meeting.

The ESTEEM clinical trial continues as a five-year-long prospective study collecting real-world long-term data from 5,000 patients from all over the world. Its current data reflect the findings of both the phase III DEFINE and CONFIRM studies.⁶