#ACTRIMS2018 – Extending Tysabri Treatment Intervals May Reduce PML Risk, TOUCH Registry Data Suggest

Extending the dosing periods of Tysabri (natalizumab) treatment may help reduce the risk of progressive multifocal leukoencephalopathy, or PML, in multiple sclerosis (MS) patients infected with the JC virus, a study suggests. The study, “Natalizumab Extended Interval Dosing Is Associated with a Reduction in Progressive Multifocal Leukoencephalopathy…

#MSParis2017 – Lemtrada and Tysabri More Efficient Than Older Injectables in Preventing SPMS Onset, Study Finds

Sanofi Genzyme‘s Lemtrada (alemtuzumab) and Biogen’s Tysabri (natalizumab) are more effective in preventing conversion to secondary progressive multiple sclerosis (SPMS) compared to older injectable drugs, researchers from the University of Cambridge in the U.K. reported at the 7th Joint ECTRIMS-ACTRIMS Meeting Oct. 25-28 in Paris. The…

Structural Eye Neurodegeneration Common Among MS Patients with Optic Neuritis, Danish Study Finds

Structural changes of the eye retina are a common feature among multiple sclerosis patients with a clinical history of optic neuritis, a Danish study finds. Loss of the myelin protective layer of optic nerve cells due to inflammation causes optic neuritis. About 20 percent of MS have it, and optic neuritis is a symptom of disease progression in about 40 percent of patients. In most cases, symptoms persist, leading to visual impairment or blindness, along with pain. Non-invasive optical coherence tomography can help evaluate neurodegeneration of optic nerve cells. This imaging technique allows a three-dimensional evaluation of internal eye structures, including the thickness of the retina nerve fiber layer. Previous studies have shown that MS patients may present progressive RNFL loss, but this can also be caused by optic neuritis. The use of OCT has been proposed to distinguish MS subtypes and evaluate disease activity. However, little clinical data is available to validate OCT's accuracy and potential as a diagnostic tool. To find out more, a Danish research team conducted a long-term evaluation of structural and functional visual outcomes in MS patients with and without a history of optic neuritis. Researchers observed that patients with a history of optic neuritis had significantly more RNFL thickness loss than those without optic neuritis. They linked reduced RNFL thickness with a 1.56 times higher risk of optic neuritis development. Nevertheless, the team did not find any association between optic neuritis and functional impairment of visual acuity or color vision. Use of high-resolution OCT devices coupled with up-do-date analysis software can improve the diagnostic efficacy of this imaging technique in MS patients, said researchers, who urged more studies to address the relevance of structural changes in MS.

Health Questionnaires Can Help to Predict ‘Hard Outcomes’ Like Survival in MS Patients, Study Says

Patient questionnaires can be sensitive to signs of disease progression and worsening in neurological disorders like multiple sclerosis just as they are in other diseases, helping doctors to better predict clinical outcomes in patients, a study reports. Particularly, the study found that MS patients with higher scores on a specific disease questionnaire were nearly six times more likely to die within 10 years than those with lower scores, and that mortality risk also jumped among people whose scores rose on a second taking of same questionnaire. But the researchers cautioned that their study was not a tool for predicting mortality but a way to help patients be more active participants in their care. “Our research shows that by answering a set series of questions, patients can have an important role in predicting long-term prognosis in diseases like MS, and that these types of questionnaire should be used by doctors to get a better idea of the patient’s health,” Joel Raffel, study’s first author, from the Imperial College London, United Kingdom, said in a university news release written by Ryan O'Hare. “We hope that using patient-reported outcomes like these more and more will mean a shift towards empowering patients," he added. "They will be able to provide their own data, so rather than the doctor telling the patient how they are doing, it’s the other way around.” Among tools often used in the clinic are patient-reported outcomes; that is, questionnaires for patients that focus on their disease and treatment. But while these questionnaires have many uses, from screening for symptoms or evaluating treatment response to improving communications, they are often under-utilized when people have MS or other neurological diseases, "in part because it is not clear if PROs [patient-reported outcomes] relate to ‘hard clinical outcomes’ like disability or mortality," the team noted. Researchers wanted to determine whether the Multiple Sclerosis Impact Scale–29 (MSIS-29) — a 29-question survey assessing quality of life and disease impact over the previous two weeks — might serve as a way of predicting a patient's risk of death. The questionnaire was completed by 2,126 people, registered with the MS Society Tissue Bank in the U.K., beginning in 2004. Of these, 872 patients repeated it one year later. By 2014, the researchers reported that 264 of the original group of MS patients (12.4%) had died, and an evaluation revealed that MSIS-29 scores were associated with 10-year mortality risk regardless of age, gender, and disability score at the time the questionnaire was completed. Indeed, patients with high scores on the MSIS-29 questionnaire, indicative of a poor quality of life, were 5.7 times more likely to die within 10 years than those whose scores were lower. The mortality risk rose further among people whose MSIS-29 score worsened between the first and second year of answering the questionnaire. “Ideally, these questionnaires should be administered routinely, once a year in the clinic or online,” Raffel said. “This could help doctors to understand what issues the patients are facing and could also help to answer big research questions around prognosis and which of the available treatments we have for MS are working.” The team believes that questionnaire responses, together with usual clinical assessment tools like imaging data through MRI scans, could help doctors and patients choose the best course of treatment.

Experts Call for Tighter Regulation of Stem Cell Therapies in Use at Clinics Worldwide

Advertising for stem cell therapies not supported by clinical research — often made directly to patients and sometimes promoted as a "cure" for diseases like multiple sclerosis or Parkinson's — is a growing problem that needs to be addressed and regulated, a team of leading experts say, calling such "stem cell tourism" potentially unsafe. Stem cell tourism is the unflattering name given to the practice of encouraging patients to travel outside their home country to undergo such treatment, typicaly at a private clinic. The article, titled "Marketing of unproven stem cell–based interventions: A call to action" and recently published in the journal Science Translational Medicine, was co-authored by scientists with universities and hospitals in the U.S., Canada, U.K., Belgium, Italy, Japan, and Australia. It focuses on the global problem of the commercial promotion of stem cell therapies and ongoing resistance to regulatory efforts. Its authors suggest that a coordinated approach, at national and international levels, be focused on "engagement, harmonization, and enforcement in order to reduce risks associated with direct-to-consumer marketing of unproven stem cell treatments." Treatments involving stem cell transplants are now being offered by hundreds of medical institutions worldwide, claiming efficacy in repairing tissue damaged by degenerative disorders like MS, even though those claim often lack or are supported by little evidence . They also noted that the continued availability of these treatments undermines the development of rigorously tested therapies, and potentially can endanger a patient's life. The researchers emphasize that tighter regulations on stem cell therapy advertising are needed, especially regarding potential clinical benefits. They support the establishment of international regulatory standards for the manufacture and testing of human cell and tissue-based therapies. "Many patients feel that potential cures are being held back by red tape and lengthy approval processes. Although this can be frustrating, these procedures are there to protect patients from undergoing needless treatments that could put their lives at risk," Sarah Chan, a University of Edinburgh Chancellor’s Fellow and report co-author, said in a news release. Chan and her colleagues are also calling for the World Health Organization to offer guidance on responsible clinical use of cells and tissues, as it does for medicines and medical devices. "Stem cell therapies hold a lot of promise," Chan said, "but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments." According to the release, the report and its recommendations followed the death of two children at a German clinic in 2010. The clinic has since been shut down. Certain stem cell therapies — mostly involving blood and skin stem cells – have undergone rigorous testing in clinical trials, the researchers noted. A number of these resulted in aproved treatments for certain blood cancers, and to grow skin grafts for patients with severe burns. Information about the current status of stem cell research and potential uses of stem cell therapies is available on the website EuroStemCell.

Decisions to Stop Taking Tysabri for MS Are Often Subjective, Study Concludes

Many decisions to stop taking the multiple sclerosis treatment Tysabri (natalizumab) appear to be based largely on subjective factors such as patients’ or physicians’ view of the risk, rather than objective assessments of the risk, a study indicates. Tysabri is an approved immunotherapy for active relapsing-remitting multiple sclerosis (RRMS). Despite its benefits, there…

MS Patients Face Higher Risk of Contracting Kidney, Bladder Stone Disease, Study Finds

People with multiple sclerosis (MS) are more likely to develop kidney or bladder stones than those without MS, a new study concludes. The report, “Multiple sclerosis and nephrolithiasis: a matched-case comparative study,” appeared in the journal BJU International. Stone disease is highly lethal in patients with spinal cord injury (SCI), a condition that,…

Women in Family with MS Seen to Be at Particular Risk of Developing Disease

Family members of multiple sclerosis (MS) patients who are asymptomatic but at a higher risk of developing the disease themselves are more likely to have early signs of the disease, according to a study published in JAMA Neurology and titled "Assessment of Early Evidence of Multiple Sclerosis in a Prospective Study of Asymptomatic High-Risk Family Members". These people should therefore be closely monitored.

Copaxone Use During Pregnancy by RMS Patients Now Possible in EU

European users of Copaxone (glatiramer acetate injection, Teva Pharmaceutical) to treat relapsing forms of multiple sclerosis (RMS) will no longer see a warning that the drug should not be used during pregnancy. A report assessing this change in the drug’s marketing authorization within the European Union — a process known as…