Recent News and Study Updates in MS Research
By Tom Garry
Reviewed by Dr. Barry A. Hendin, MSAA Chief Medical Officer
Ublituximab shows reductions in disease progression in relapsing MS
Ublituximab is an investigational medication being evaluated by the Food and Drug Administration (FDA) for the treatment of relapsing forms of MS. The medication is a monoclonal antibody that targets CD20, a protein found on the surface of B cells, which are white blood cells shown to play a role in MS. Ublituximab is given by infusion, with two initial doses administered 14 days apart, followed by infusions every 24 weeks.
In the Phase III ULTIMATE I and ULTIMATE II studies, people with relapsing MS who received ublituximab had a lower average annualized relapse rate (ARR) than others with relapsing MS who received an FDA-approved medication, Aubagio® (teriflunomide). Study measures indicating less disability progression also favored ublituximab.
The FDA is evaluating data from the ULTIMATE I and II trials. The agency is scheduled to make a decision on the approval of ublituximab in relapsing forms of MS by December 28, 2022.
Assessing the efficacy and safety of evobrutinib over 2.5 years
Following up on a 48-week trial that yielded encouraging findings on evobrutinib, an investigational medicine being developed to treat relapsing forms of MS, a 2.5-year study found that the therapy showed continued efficacy, with no new safety risks.
Evobrutinib inhibits Bruton tyrosine kinase, an enzyme that plays a crucial role in the development of B cells, which, in turn, play a role in MS. In the 48-week study, 267 people with relapsing forms of MS received either placebo, one of three doses of evobrutinib, or dimethyl fumarate, an FDA-approved disease-modifying therapy.
At the end of the 48-week study, 213 participants, or 80% of the total, opted to enter the longer-term extension study. All patients in that study received 75 mg of evobrutinib once daily before progressing to 75 mg twice a day. Of those who completed at least 132 weeks of treatment in the open-label extension (OLE), data showed that the annualized relapse rate was 0.12, reflecting one relapse over the course of roughly eight years. Fifty-nine people, or 27.7% of the group, had an adverse event that study investigators believed was related to treatment. Six of those treatment-related adverse events were considered serious.
Two studies highlight the beneficial role of diet in managing MS
Two studies presented at the 2022 Annual Meeting of the American Academy of Neurology (AAN) meeting add to the growing body of evidence indicating that diet can have a significant, positive impact on the course of MS.
The first study involved 500 people with MS, 70% of whom were women. Those study participants completed the Mediterranean Diet Adherence Screener (MEDAS), which measures the extent to which people follow a diet consisting predominantly of plant-based foods, with fish, poultry, and dairy eaten in moderation, and red meat and sweets eaten only occasionally.
Researchers found that greater adherence to a Mediterranean diet was associated with better functioning as measured on the Multiple Sclerosis Functional Composite (MSFC) and less cerebral atrophy on MRI. Study authors said that their findings suggest the possibility of a neuroprotective mechanism with the Mediterranean diet, but added that long-term studies and interventional clinical trials are needed to further explore that possibility.
The second study assessed the safety and tolerability of a ketogenic diet (KD) in 65 people with relapsing MS, and also evaluated how the diet affected several measures of clinical status. A ketogenic diet is a low-carbohydrate, high-fat diet similar in some ways to the Atkins diet. Research has shown that the diet mimics the fasting state and plays a role in immune system regulation. Study participants were asked to follow this eating plan for six months.
Eighty-three percent of the study subjects adhered to the ketogenic diet for the full six months. At the end of that period, they showed – on average – less fatigue and depression, improved physical and mental quality of life, reduced fat mass, an ability to walk further over the course of six minutes, and reduced MS-related disability as measured by the Expanded Disability Status Scale (EDSS). Laboratory tests conducted as part of the study found that the diet also reduced pro-inflammatory peptides in the body while increasing levels of anti-inflammatory peptides.
Can intravaginal estrogen help improve bladder dysfunction symptoms?
A small study suggests that intravaginal application of estriol, a form of estrogen, can significantly reduce the symptoms of bladder dysfunction, which are experienced by most people with multiple sclerosis (MS).
The pilot study involved 12 women with relapsing-remitting MS. All of the women had reached menopause or had undergone hysterectomy. None had a history of breast, uterine, or ovarian cancer. The women were prescribed 1 mg of estriol applied intravaginally by an applicator. They used the estriol in addition to any other medications they might be taking to improve their symptoms, such as prescription medicines to reduce urinary frequency.
Participant questionnaire responses showed statistically significant improvements in mental and physical aspects of quality of life, and improvements related to urinary urgency, urinary frequency, and frequency of urinary tract infections. While this treatment approach will need to be further evaluated, these findings suggest that women with RRMS may have a new option for dealing with urinary issues.
For More Information
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