Trials of IMU-838 in RRMS, Progressive MS Start Later This Year

The U.S. Food and Drug Administration has cleared Immunic Therapeutics to initiate two clinical trials of its investigational medication IMU-838 (vidofludimus calcium) in people with relapsing-remitting multiple sclerosis (RRMS), as well as a separate trial for people with progressive types of MS. The RRMS clinical trial program, expected…

First SPMS Patient Dosed With Foralumab Nasal Spray

Foralumab, an investigational anti-CD3 antibody that is administered via a nasal spray, has been given for the first time to a person with secondary progressive multiple sclerosis (SPMS). It was administered under an Individual Patient Expanded Access Program, which earned approval from the U.S. Food and Drug Administration in…

Helper T-cells Drive Transition from RRMS to SPMS, Study Suggests

A group of helper T-cell (Th cells), a type of immune cell, could be responsible for the transition from relapsing-remitting multiple sclerosis (RRMS) to secondary progressive multiple sclerosis (SPMS), with important implications for diagnosing and treating SPMS, a new study found. The study, “Involvement of cytotoxic Eomes-expressing…

NICE Does Not Favor Adding Mayzent to NHS England for Active SPMS

The National Institute for Health and Care Excellence (NICE) is recommending against Mayzent (siponimod) as a treatment for active secondary progressive multiple sclerosis (SPMS) in the U.K., because its cost-effectiveness relative to an existing treatment for these patients is not known. NICE’s draft guidance for Mayzent is open…

Ocrevus Use Still Growing in Europe But Challenges on Horizon, Spherix Reports

Prescriptions of Roche’s Ocrevus (ocrelizumab) among multiple sclerosis (MS) patients initiating or switching a disease-modifying therapy (DMT) continue to rise in Europe, according to a survey conducted by Spherix Global Insights. Ocrevus, an anti-CD20 monoclonal antibody administered directly into a vein, was approved in the European Union to treat active forms…

Ocrevus Top Choice of US Neurologists for Active SPMS, But Mayzent and Mavenclad Gaining Interest, Report Says

Genentech‘s Ocrevus (ocrelizumab) continues to be the most prescribed medication to reduce inflammatory disease in people with active secondary progressive multiple sclerosis (SPMS) among U.S. neurologists, even though Novartis’ Mayzent (siponimod) and EMD Serono’s Mavenclad (cladribine) were approved in March to treat this same MS…

CHMP Favors Mayzent as Oral Treatment Specifically for Active SPMS Patients in EU

The Committee for Medicinal Products for Human Use issued an opinion supporting Mayzent (siponimod) as an oral treatment specifically for adults with active secondary progressive multiple sclerosis in the European Union. Opinions released by CHMP, an arm of the European Medicines Agency, carry weight and are generally accepted by the European Commission, which makes the final decisions. As such, Mayzent — developed and marketed by Novartis — is expected to become the first oral treatment indicated only for people with active SPMS, defined as patients with evident relapses or inflammatory activity in lesions captured on imaging scans. “Today’s CHMP opinion marks a milestone in supporting people in Europe who are living with active SPMS,” Christoph Thalheim, director of external affairs for the European Multiple Sclerosis Platform, said in a Novartis press release. “This decision brings hope of a possible new and beneficial therapy.” Mavenclad (cladribine tablets), by the Merck Group, became the first oral therapy for select SPMS patients in the EU. Its 2017 EU approval included all with highly active relapsing MS, including those with relapsing-remitting disease as well as SPMS. The U.S. Food and Drug Administration (FDA) approved Mavenclad for this same patient group — active relapsing MS — in March 2019. CHMP based its opinion on findings in the Phase 3 EXPAND clinical trial in 1,651 patients with SPMS, both active and non-active. According to Novartis, a subgroup analysis showed that 2 mg tablets of Mayzent taken once a day lowered disability progression at three months by 31% in those with active disease, compared with placebo treatment. At six months, time to confirmed disease progression in active SPMS patients was delayed by 37% overall compared with placebo. The therapy's use also decreased the annualized relapse rate — the number of confirmed relapses each year — by 46% compared with placebo, Novartis reported. Furthermore, data presented in September at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), suggested that Mayzent can help patients prolong the time until becoming wheelchair-bound by more than four years. “For people living with MS, it is extremely important to delay disability progression and preserve cognition, so that they can live independent lives for longer,” said John Tsai, the company's chief medical officer and head of global drug development. “Mayzent is a testament to the Novartis mission to reimagine medicine for an underserved population such as people living with active SPMS.” Mayzent works by blocking the activity of two sphingosine-1-phosphate receptors on the surface of immune cells. It prevents immune cells from migrating to the brain and spinal cord, thereby reducing the inflammatory process that promotes MS development and progression. Should the European Commission support CHMP's opinion, health authorities in each EU member state will then need to decide whether to bring Mayzent into their respective public health programs, where patients can access the treatment at low or no cost. "The next step is for UK health bodies to decide whether siponimod should be available on the NHS [National Health Service]," the U.K.'s MS Society said in announcing CHMP's decision. "We’ll be working hard to make sure that happens as soon as possible. But the process can take some time, and we don't expect a decision until the middle of 2020." In the U.S., Mayzent is FDA-approved for adults with all relapsing MS forms, including clinically isolated syndrome (CIS), RRMS, and active SPMS. For more information about this therapy, please read MS News Today's September interview with Ludwig Kappos, MD, principal investigator of the EXPAND trial.

Emotional Disturbances and SPMS

About 65% of patients with relapsing-remitting multiple sclerosis (RRMS) will progress to a second stage of the disease called secondary progressive multiple sclerosis (SPMS). People with SPMS often have a variety of symptoms that can lead to a roller coaster of emotional changes. Here are some ways to…

Study: 40% of SPMS Patients in Italy and Germany Unaware of Diagnosis

A new study shows that 40% of patients in Italy and Germany who have  secondary progressive multiple sclerosis (SPMS) are not aware of their diagnosis, indicating a need for significant improvement in patient-physician communication. The study, “Conversion to Secondary Progressive Multiple Sclerosis: Patient Awareness and Needs. Results From an Online Survey in Italy and Germany,” was published in the journal Frontiers in Neurology. Approximately 15 years after the clinical onset of relapsing-remitting multiple sclerosis (RRMS), more than 50% of patients develop SPMS. SPMS is characterized by irreversible progression of disability that is independent of a relapse, although patients with SPMS can still experience relapses (active SPMS). Conversion of a patient from RRMS to SPMS is considered a key determinant of long-term disease prognosis. The RRMS–SPMS transition also is important from the psychosocial point of view. Patients with SPMS and their families face not only new-found uncertainty, but also have to adjust to a new reality of symptoms, limitations to their daily activities, and the scarcity of effective disease-modifying treatments (DMTs). Managing the Transition to SPMS (ManTra) is a project being conducted in Italy and Germany to develop and evaluate complex interventions for newly-diagnosed SPMS patients. The project goals are to assess the experiences and needs of people who have recently converted to SPMS, and to set up a user-led resource to improve the quality of life and autonomy of patients with newly diagnosed SPMS. In previous ManTra project actions, researchers identified the needs of patients transitioning to SPMS via a literature review and a qualitative study, which was composed of semi-structured interviews with recently diagnosed SPMS patients, patients' significant others, neurologists, and other health professionals. In this study, researchers document the results of an online patient survey conducted in Italy and Germany to assess the experiences of people recently diagnosed with SPMS (within five years or less), and to verify whether the needs identified in the qualitative ManTra study are applicable to a larger sample of SPMS patients. Additionally, researchers explored the characteristics associated with patient awareness of RRMS–SPMS transition. Among the 215 participants in the study, 57% of patients in Italy were aware of their SPMS diagnosis, compared to 77% of patients in Germany. In both countries, more than 80% of participants who were aware of their condition received a SPMS diagnosis from a neurologist. The satisfaction with the manner in which their diagnosis was disclosed to them was moderate to high. Nevertheless, 28%–35% of patients obtained second opinions, and 48%–56% reported they did not receive any information about that form of the disease. Furthermore, 63% of participants in Germany were actively seeking further information regarding their diagnosis, compared to only 31% in Italy. Geographic area was found to be an independent variable associated with patient awareness, as patients in central and southern Italy were less likely to be aware of their condition, compared to patients in Germany. Additionally, activity limitations were another independent variable associated with patient awareness, as patients with activity limitations were 7.8-times more likely to be aware of their diagnosis compared to autonomous patients. “The logistic model found that patients fully dependent in activities of daily living were at higher odds of being aware of their conversion to SPMS, indicating that they probably realized that they had achieved irreversible disability progression,” researchers wrote. Regarding the previously pre-specified needs identified in the ManTra project, "patients scored all the 33 pre-specified needs as a lot to extremely important, without any differences between those aware and not aware/unsure of their conversion to SPMS, and across countries," researchers wrote. Of note, two prioritized needs — "physiotherapy" and "active patient care involvement" — were shared by both Italian and German patients. Two others differed across countries, with "individualized healthcare plan," and "information on social rights and policies" being more important in Italy, while "psychological support" and "cognitive rehabilitation" were more of a priority in Germany. Overall, the team concluded that "around 40% of these patients were not aware of their disease form, indicating a need to improve patient-physician communication. Physiotherapy and active patient care involvement were prioritized in both countries.” According to the study, the formulation of a SPMS diagnosis is not straightforward; however, it is a key prognostic factor that affects decisions and planning at the healthcare and personal level. As a result, the researchers emphasized that "a clear and effective communication to the patient is an ethical imperative.”

Vumerity Approved in US as Treatment for RRMS and Active SPMS

The U.S. Food and Drug Administrationhas approved Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting MS , and active secondary progressive disease. Vumerity (previously known as ALKS 8700) was developed by Alkermes in collaboration with Biogen, the latter of which now holds the exclusive worldwide rights to commercialize the therapy. Taken orally, Vumerity is able to regulate immune responses and lower oxidative stress, helping to prevent the degeneration of myelin (the protective coat of nerve cells) in MS patients without inducing a systemic inhibition of the immune system. The therapy is rapidly converted into monomethyl fumarate (MMF), and although its mode of action is not fully understood, MMF is believed to have fewer gastrointestinal side effects than Tecfidera (dimethyl fumarate, also marketed by Biogen), an FDA-approved oral therapy for relapsing MS. “The FDA’s approval of Vumerity delivers on Biogen’s commitment to pursue new therapies that may provide meaningful impact for people living with relapsing MS, and we look forward to bringing it to the MS community as an additional treatment option,” Alfred Sandrock, Jr., MD, PhD, executive vice president, research and development, and chief medical officer at Biogen, said in a press release. “Vumerity is a novel fumarate that offers the well-characterized efficacy of Tecfidera (dimethyl fumarate), and has been studied for improved patient-reported gastrointestinal tolerability,” Sandrock added. Craig Hopkinson, MD, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes, added: “The approval of Vumerity for relapsing MS marks the culmination of a multi-year development program and is the latest milestone in our mission to develop new treatments for patients living with chronic central nervous system disorders. “We are grateful to the patients and study investigators who have participated in our Vumerity clinical trials, and we look forward to working with our collaboration partners at Biogen to make this new treatment available to patients,” Hopkinson said. The FDA’s decision to approve Alkermes' new drug application was based in part on data from the pivotal Phase 3 EVOLVE-1 clinical trial that showed the long-term safety and effectiveness of the therapy, given twice daily, in patients with RRMS. The trial is still ongoing at more than 100 sites in the U.S. and Europe. Data collected after one year of treatment showed an 83% decline in the adjusted annualized relapse rate from baseline in patients newly diagnosed with MS, while for patients who had been treated previously, the adjusted annualized relapse rate decreased by 72%. In addition, preliminary data from brain magnetic resonance imaging (MRI) scans revealed that patients had significantly fewer active brain lesions after 48 weeks of treatment with Vumerity. Other studies comparing Vumerity with Tecfidera, namely the EVOLVE-MS-2 trial (NCT03093324), further showed that Vumerity was generally safe and well tolerated, with patients having fewer gastrointestinal reactions and no reports of serious side effects. The most common side effects associated with the treatment included flushing (redness of the skin, normally in the neck and cheeks), nausea, and diarrhea. “MS is a heterogeneous disease, and real-world patient circumstances can vary, reinforcing the benefits of having therapeutic choices to support the diverse range of treatment considerations,” said Robert Naismith, MD, a professor of neurology at Washington University School of Medicine in St. Louis. “Throughout its clinical development program, Vumerity has demonstrated a desirable therapeutic profile, making it a compelling new option for patients.” Bruce Bebo, PhD, executive vice president, research at the National MS Society, concluded: “MS is a lifelong disease that has a significant impact on the people affected and their caregivers. We are encouraged by the progress being made in the treatment of MS, and pleased that another treatment option will soon be available. It’s important for people with MS to have treatments that are both efficacious and tolerable to help manage their disease.”

Is SPMS Going to Affect My Life Expectancy?

Receiving a diagnosis of multiple sclerosis (MS), a progressive neurological disorder, can be frightening. One of the first things patients ask is — what does this mean for me? Will my life expectancy drop with this diagnosis? What is life expectancy? Life expectancy is a “best guess” of…

SPMS and Diet: What Foods Can Help?

Many treatments for multiple sclerosis (MS) are targeted at reducing inflammation, thereby slowing progression of the autoimmune disease. An anti-inflammatory diet also may slow disease progression, as well as enhance the positive effects of anti-inflammatory medications. In MS, the immune system mistakenly attacks the protein coat that surrounds nerve fibers. That coating protects the nerves and facilitates the propagation of nervous signals. Secondary progressive multiple sclerosis (SPMS) is the second stage of MS, which follows relapsing-remitting multiple sclerosis (RRMS). Appropriate exercise and healthy eating habits are important for all people with MS. What is an anti-inflammatory diet? An anti-inflammatory diet is a plan for healthy eating that does not contain foods that are high in saturated fats, refined carbohydrates — found in white bread — sugary desserts, soda, and red meat. Foods that are part of an anti-inflammatory diet include tomatoes, olive oil, green leafy vegetables, nuts such as almonds and walnuts, fatty fish — including salmon, tuna, and sardines — and fruits such as strawberries, blueberries, cherries, and oranges. How can an anti-inflammatory diet help me? It has been proposed that an anti-inflammatory diet may be able to help slow disease progression in autoimmune disorders. Clinical trials are underway to test this hypothesis in patients with different types of MS. Although several studies have been conducted, it is difficult for many reasons to draw broad conclusions as to the benefits of diet. For example, many studies have not included good controls and have relied on patient-reported information. What has been shown, however, is that diets with inflammatory potential may be involved in the physiological processes associated with neurodegenerative diseases. How should I start an anti-inflammatory diet? Before making any big changes, it's always a good idea to talk to your physician and a registered dietitian. They can help you figure out foods to include and avoid, while making sure you are getting the nutrition and vitamins you need.

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