Author Archives: Marta Figueiredo PhD

Most MS Patients OK With Intravenous Treatment Conditions, Study Suggests

Most patients with multiple sclerosis (MS) are satisfied with the conditions of their intravenous therapy (administered directly into the bloodstream) and are very aware of the therapy’s safety, according to a small Macedonian study. Also, establishing a specialized infusion center would substantially increase intravenous treatment satisfaction and adherence. The study, “…

Blood Levels of IgG3 Antibodies May Predict Faster Shift to MS in Clinically Isolated Syndrome Patients, Study Says

Higher-than-usual levels of specific antibodies in the blood of patients with clinically isolated syndrome (CIS) may predict a faster progression to multiple sclerosis, an Australian study reports. The specific antibody is known as IgG3, an immunoglobulin known to promote inflammation. CIS is a first episode — one lasting at least 24 hours but typically followed by full recovery — of neurological symptoms caused by inflammation and the loss of myelin, the protective layer of nerve fibers. CIS is known to often precede the development of MS, a progressive disease marked by the immune system attacking myelin in the central nervous system (the brain and spinal cord). Diagnosing this condition currently includes imaging scans to check for evidence of CNS inflammation and demyelination (lesions), and blood tests to rule out other possible causes of the symptoms experienced, which can range from vision problems (optic neuritis), to muscular weakness or extreme nausea. No reliable biomarkers exist to that might guide prognosis, or likely outcomes, in a person with CIS, the study noted, only historical knowledge that an earlier age at CIS onset and evidence of multiple lesions (nine or more) on an MRI scan are associated with a high risk of conversion to MS. Blood biomarkers that help to predict the likely length of time to such conversion would be of considerable value, especially in allowing for better and more timely treatment decisions. Increasing evidence has shown that B-cells — a type of white blood cell that produces antibodies against pathogens and is involved in inflammatory responses — are critical players in MS development. Both CIS or MS patients have B-cells in the cerebrospinal fluid — the fluid that fills the brain and spinal cord – a hallmark of central nervous system inflammation and one associated with brain lesion severity. But while changes in the levels of specific antibodies have been associated with other inflammatory neurodegenerative disorders, no MS-specific antibodies have been identified so far. Researchers in Australia investigated whether specific types of immunoglobulin — an immune system antibody — might be specific to CIS and MS, and if so, whether they could predict rate of progression from CIS to MS. They analyzed the levels of several Ig antibodies — IgG, IgA, and IgM — in blood samples of 20 people recently diagnosed with CIS, eight MS patients, and 10 healthy individuals. Those with CIS had participated in the PhoCIS study, a trial evaluating whether phototherapy could prevent MS conversion in a high-risk CIS group. Sixteen of thsse 20 patients converted to MS within 12 months of blood collection. Results showed that CIS patients had significantly lower levels of IgG and IgG2 (which could partially explain the lower levels of total IgG) compared to healthy people. MS patients also had significantly reduced levels and proportions of IgG2 (within IgG total levels), but increased levels of IgM and proportions of IgG1 and IgG3 compared to healthy individuals. The team believes these differences could be markers of an MS-related abnormal production of Ig antibodies by B-cells. Researchers also found a significant association between the proportions of IgG3 and the frequency of immature circulating B-cells in CIS patients. Further, higher levels of IgG3 and a higher proportion of IgG3 in the blood of people newly diagnosed with CIS were seen to be significantly associated with faster progression to MS. This suggests that IgG3 levels and/or proportions of total IgG are potential predictive biomarkers of rapid conversion of CIS to MS, and could be used to guide treatment decisions in individuals with CSI, the researchers said. Since IgG3 is known to be a potent pro-inflammatory antibody, it “could actively contribute to systemic pro-inflammatory immune responses in CIS and MS,” they wrote. The team also noted that larger studies are needed to confirm these results and the predictive value of blood IgG3 levels in the progression of CIS to MS.

Laquinimod Fails to Slow Brain Atrophy and PPMS Progression, Says Developer Active Biotech

Sweden's Active Biotech said its experimental therapy Laquinimod failed to meet the primary and secondary objectives of Phase 2 clinical trial evaluating the drug's potential to treat primary progressive multiple sclerosis. Laquinimod, also known as Nerventra or ABR-215062, was developed by Active Biotech and Israel's Teva Pharmaceutical Industries. The drug targets inflammation and degeneration in neurological tissue. Preclinical studies using animal models of multiple sclerosis showed that laquinimod regulated inflammatory and immune responses in these animals, reducing disease progression. The ARPEGGIO Phase 2 study aimed to evaluate laquinimod's efficacy, safety and tolerability in PPMS patients. Its primary endpoint was brain atrophy as defined by percent brain volume change. Secondary goals included time to disability progression, change in timed 25-foot walk, and number of new T2 lesions. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 374 individuals. Initially, the study aimed to evaluate two doses of laquinimod — 0.6 and 1.5 mg/day — in PPMS compared to placebo. However, the highest dose was discontinued in January 2016 after some participants reported adverse cardiovascular events. In a Dec. 1 press release, Active Biotech said the lower dose of laquinimod failed to slow both the rate of brain atrophy and disease progression. “There was, however, a reduction in new T2 lesions observed in patients treated with laquinimod 0.6 mg,” said the company's president and CEO, Helén Tuvesson. The trial revealed a similar safety profile to that observed in previous studies in relapsing-remitting MS patients (RRMS). The most common adverse reactions were headache, nasopharyngities, upper respiratory tract infection,and back pain. Results of the ARPEGGIO trial will likely be presented at a future scientific conference and published in a scientific journal. Earlier this year, Active Biotec stopped developing laquinimod as a potential RRMS treatment after a Phase 3 study failed to achieve its primary goal: slowing disease progression. Laquinimod is also being evaluated as a potential therapy for Huntington’s disease in a Phase 2 clinical trial.

Survey Helps Improve Communication Between Women with MS and Healthcare Providers

A national survey in the U.S. revealed that 98% of women newly diagnosed with multiple sclerosis struggle to discuss important personal concerns with their healthcare team. The survey was conducted online by Wakefield Research on behalf of Teva Pharmaceutical among 1,000 women diagnosed with MS in the last five years. Survey results were used by Teva and the nonprofit group Can Do MS to develop tools to improve communication between women with MS and healthcare professionals upon a disease diagnosis. The survey examined the concerns women face after an MS diagnosis, including: ability to care for themselves (reported by 34% of the women surveyed), ability to care for their current or future children (22%), career and work life demands (17%), ability to have children (15%), and personal relationships (13%). The study also showed that 71% of participants believed talking to their doctor earlier or more openly about those subjects would have helped them in the first six months after their diagnosis. The main reason women cited for not discussing those concerns with a healthcare professional was the discomfort in doing so. “Having open and candid conversations with your doctor is a cornerstone of great care and disease management, especially when you have a chronic condition like MS,” Lori Travis, a board-certified neurologist and MS expert practicing at Phoenix Neurological Associates in Arizona, said in a press release. “The survey findings indicate a strong need for patients and doctors to improve communication and overcome any discomfort there may be around these topics,” Travis added. Around half of the participants wished they would have covered topics with their healthcare team such as intimacy with a partner (50%), talking about MS with their family (52%), and accepting help from others (51%). Although there is no evidence to suggest that MS patients are less likely to conceive, many also were concerned about not being able to have children. Regarding their careers, 52% of the women said that a more informative conversation at the time of diagnosis would have improved the course of their professional lives. “The compelling findings from this survey, coming straight from women who have already traveled this road, have helped us get right to the heart of the questions and concerns they wished they asked their healthcare team at the start of their MS journey,” said Amanda Welch, director of MS marketing at Teva. “These insights can help deepen our understanding of what women face and how we can offer support during the critical and emotional time immediately after diagnosis” Welch added. The tools created by Teva and Can Do MS to help women and healthcare professionals address relevant topics are available here. “At Can Do MS, we are committed to helping people affected by MS increase their education, expand their knowledge and talk openly about what they want now and in the future,” said Anne Lee Gilbert, director of programs at Can Do MS.

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