We look forward to reporting more news to patients, family members, and caregivers dealing with MS during 2019.
Here are the top 10 most-read articles of 2018, with a brief description of what made them relevant for the MS community.
A 27-month follow-up study of the MS-SPI Phase 3 trial (NCT02220933) showed that treatment with MedDay Pharmaceuticals’ therapy MD1003 — a highly concentrated oral formulation of biotin — led to sustained lessening of disability in patients with progressive MS who received the treatment over 36 months. The results showed that the benefits in disability and exercise capacity were sustained throughout the three year-period. Patients who took MD1003 over the initial placebo-controlled nine months had better results than those who switched to the treatment candidate after receiving placebo, suggesting that “earlier treatment leads to a lower disability,” the researchers wrote. Treatment with MD1003 was well-tolerated.
The National MS Society issued a press release covering studies it is supporting to improve gait and balance, as well as to remind MS patients of the importance of exercise and diet. This news resulted from the 7th International Symposium on Gait and Balance in MS, which was held September 2017 and brought together, among others, researchers, clinicians, and engineers. Research presented at the meeting and highlighted by the MS Society reported an impaired ability of MS patients to correct themselves after a disturbance in walking, their reduced daily step count over one year, their increased tendency to lose balance and to have a sedentary behavior. According to the MS Society, effective rehabilitation strategies to improve balance and gait in MS patients are essential.
Off-label use of the lymphoma and rheumatoid arthritis treatment rituximab — marketed as Rituxan by Genentech — was effective and safe in patients with either MS, myasthenia gravis or neuromyelitis optica, who received the treatment over three to seven years. Rituximab targets a protein called CD20 in immune B-cells. The findings revealed complete depletion of circulating B-cells in most patients, and a marked depletion in some throughout the treatment period. Rituximab was well-tolerated, with a low rate of adverse side effects.
In April we reported a study showing that infection with the common Epstein-Barr virus (EBV) may increase the risk for MS, as well as systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, celiac disease, inflammatory bowel disease, and type 1 diabetes. EBV, which causes mononucleosis, invades and takes control of immune B-cells. Specifically, the team found that the virus-derived EBNA2 transcription factor (a tiny protein that regulates gene expression) binds to several spots in the human genome that are associated with these seven diseases.
A Phase 1 trial (NCT01933802) showed that a stem cell approach eased neurological symptoms in 15 of 20 progressive MS patients. These mesenchymal stem cell-derived nerve cell progenitors, which were injected into the spinal canal, also improved muscle strength and bladder function in some patients. The treatment consisted of three injections of patient-derived stem cells, administered three months apart within 30 minutes of cell harvesting. Half the patients were unable to walk at the beginning of the study and eight required assistance to walk. Two of the patients unable to walk were able to complete a walking test with assistance after the stem cell treatment. No serious side effects were reported. A Phase 2 trial (NCT03355365) is recruiting participants to further test the approach in progressive MS patients.
Matthew Makelky, PharmD, a researcher at the University of Colorado, addressed the status and advances in cannabinoids use for MS at the 2018 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC). Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the most thoroughly studied cannabinoids in MS. Although oral cannabis extract and synthetic THC were reported to ease spasticity-related symptoms and pain in MS patients, no form of cannabinoids is effective for MS-related urinary symptoms and tremor. Makelky also noted that finding suitable dosage regimens and methods of administration for the various cannabinoid compounds may be challenging, and cautioned that cannabinoids may interact with other prescribed drugs.
Results of a Phase 1/2 clinical trial (NCT02034188) showed that treatment with mesenchymal stem cells (MSCs) collected from the umbilical cord led to sustained lessening of disability in MS patients. The team at the Stem Cell Institute, in Panama, recruited 20 MS patients, 15 of whom had relapsing-remitting MS. All received seven intravenous infusions of 20×106 cells over one week. Besides easing disability — particularly at one month of treatment — the stem cells improved hand function and average walk time, while lessening bladder, bowel, and sexual dysfunction. No serious adverse side effects were found. The patients also reported improved quality of life. Fifteen of 18 patients showed inactive brain lesions one year after the treatment; one had almost complete elimination of lesions. At the same one-year evaluation, the team found that the reduced disability was sustained.
Having been approved by the U.S. Food and Drug Administration (FDA) in 2017, articles on Ocrevus (ocrelizumab, by Genentech) generated significant interest from our readers over 2018. One year after its approval Robert Lisak, a neurologist involved in the Phase 3 clinical trials testing Ocrevus, said it was still too early to predict if the therapy will be the game-changer its developers believed it could be, as well as to assess its side effects. “To say before two years what’s going on is impossible,” he said. However, “quite a few patients” who were doing poorly and switched from other medications to Ocrevus “seem to be doing well,” Lisak added. Lori Mayer, the director of medical research at Central Texas Neurology Consultants and also involved in Ocrevus’ clinical trials, said patients on this therapy showed more stability compared to those on other therapies. She also said that Ocrevus is tolerated “really well,” and that “progressive patients that are on Ocrevus are really excited” for having the first disease-modifying treatment.
Our February interview with Hideki Garren, MD, PhD, Global Head of Multiple Sclerosis and Neuroimmunology at Genentech, was the second-most read MS article of the year. By the end of 2017, more than 30,000 patients had been treated with Ocrevus, which already had been approved in 50 countries, he noted. “We have been very pleased by the overwhelmingly positive reception that Ocrevus has had,” Garren said. Available data showed that, compared to Rebif (interferon beta-1a), the treatment increased the proportion of patients with no signs of relapses or disease progression, including preserved hand/arm function and walking ability, while also improving visual acuity. Ocrevus also reduced the risk of more severe disability in the hands or arms of patients with primary progressive MS. Infusion-related reactions were the most common adverse side effects in both clinical trials and real-world data.
Our most-read article of 2018 reported a study in mice with sciatic nerve injury that showed that temporary, precisely-regulated inhibition of an enzyme called histone deacetylase 3, or HDAC3, markedly boosted the formation of myelin — the protective layer of nerves, whose progressive loss is a hallmark of MS. This was associated with functional recovery in treated mice. HDAC3 slows myelin production when nerves are forming or after their injury. The team already had begun tests in mouse models of MS and other diseases also caused by myelin damage. Successful results may lead to a Phase 1 clinical trial in MS patients.
At Multiple Sclerosis News Today we hope these stories and our reporting throughout 2019 contribute to informing and improving the lives of everyone affected by MS.
We wish all our readers a happy 2019.
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