Patricia Silva, PhD, director of science content —

The European Commission has approved Merck KGaA’s Mavenclad (cladribine tablets) to treat highly active relapsing forms of multiple sclerosis (MS). The Aug. 25 decision in Brussels marks the first approval of a highly efficient oral short course therapy for MS in Europe. Mavenclad has been shown to harness disease activity for…

Omega-3 fatty acids might reduce inflammatory processes by boosting a mechanism that cleans out dysfunctional or unnecessary proteins in a certain type of immune cells, according to a study published in the journal Autophagy. These insights indicate that omega-3 supplements might be beneficial for certain multiple sclerosis (MS) patients,…

Brain donation for multiple sclerosis research optimizes the chances that a cure might be discovered. It might result in a vaccine or other preemptive strike to prevent the disability from starting in the first place. As addressed in a previous column, there is a shortage…

Merck’s Mavenclad tablets significantly improve quality of life among relapsing multiple sclerosis patients while reducing the number of relapses, according to new analyses of previously unpublished data from clinical trials assessing the drug. This new data, published in the Multiple Sclerosis Journal, come just as the European Commission ponders whether to approve the once- rejected therapy to treat relapsing forms of MS. Its decision is expected later this month, seven years after a perceived increased of cancer risk led the European Medicines Agency (EMA) to block Mavenclad. In 2011, the U.S. Food and Drug Administration (FDA) rejected the medication, forcing its eventual withdrawal from the Australian and Russian markets, where it had already been licensed. For the study, researchers at Queen Mary University of London used data obtained from the EMA through a Freedom of Information request. They analyzed data from the Phase 3 CLARITY trial, which compared Mavenclad to placebo. The trial's 1,326 participants completed a quality-of-life questionnaire that focused on disease aspects such as mobility, self-care, usual activities, pain or discomfort, and anxiety. After two years, those on Mavenclad had significantly improved their quality of life compared to the control group, particularly in terms of self-care. Mavenclad also helped mobility, which might be related to its ability to prevent relapses and delay progression, researchers said. While researchers assessed quality of life using two different questionnaires, patients had only completed one in sufficient numbers to allow for a solid analysis. The other quality-of-life tool provided researchers with numerically positive results, but the low number of responses made the result difficult to interpret. This wasn't the first time QMUL researchers have contributed in this way to knowledge of Mavenclad in MS. In 2015, they used a Freedom of Information request to obtain data showing that Mavenclad was not related to increased cancer risk. “Cladribine seemed to have such excellent potential as a treatment for MS that we thought it was tragic the development program was shelved, and significant parts of the clinical trial data remained unpublished,” study leader Klaus Schmierer, a neurologist at both QMUL and Barts Health NHS Trust, said in a press release. “In addition to the drug being highly effective, well tolerated and safe as far as short-term studies can show, we now know it also improves patients’ quality of life. The new results seemed so clear, we felt it was extremely important to publish and share these data." Mavenclad has now been studied in some 2,700 patients with relapsing MS in the Phase 3 trials CLARITY, CLARITY EXTENSION, and ORACLE-MS, as well as the Phase 2 ONWARD trial, and the ongoing long-term study PREMIERE. The treatment differs from most other oral MS therapies in that a short treatment course — a maximum 20 days — triggered effects that were upheld for two years. Studies of Mavenclad’s mechanisms suggest the drug gets such results by resetting the immune system. In June 2017, the EMA's Committee for Medicinal Products for Human Use urged the European Commission to approve Mavenclad. Merck also plans to seek U.S. approval for its therapy and is now in talks with the FDA about Mavenclad's future.

of the neurons.

The online multiple sclerosis community GeneFo will hold a webinar next week to discuss the latest research findings on how mitochondrial antioxidants may affect MS. The webinar, which will be open to patients who register, will start at 1 p.m. U.S. Eastern Standard Time on Thursday, Aug. 24. GeneFo…

The risk of people with multiple sclerosis developing cancer is higher if they have used immunosuppressants than if they haven’t, according to a study that followed more than 1,000 patients for a decade. The findings indicate that the often discussed association between MS and cancer may stem from older types of…

Secondary progressive multiple sclerosis (SPMS) patients have larger quantities of certain antibodies to the stomach ulcer bacterium Helicobacter pylori than those with relapsing-remitting multiple sclerosis (RMSS), finds a Greek study which also showed that MS patients in general differ from healthy people in this aspect. Although researchers at the University of Thessaly think…

University of California medical school researchers are looking for multiple sclerosis patients who want to participate in an international study of the bacteria that live in our gut. The University of California at San Francisco team decided to study the gut microbiome after recent evidence suggested that it is critical in…

MSWorld, one of the world’s largest patient-run organizations supporting people with multiple sclerosis (MS), plans its first patient education event, MSWorld Talks, in Pittsburgh on Aug. 14. The all-day conference is free and open to all those in the Pittsburgh area who live with MS, as well as their family…

Multiple sclerosis damages human brains, so MS researchers often study mice brains. How can multiple sclerosis be cured or prevented without studies of human brains? Researchers need the anatomical bequests of MS brains. Harvard Brain Tissue Resource Center Harvard University specifically collects and studies brains (and brain tissue),…

TG Therapeutics and the U.S. Food and Drug Administration (FDA) have agreed on a special protocol assessment for a Phase 3 trial program evaluating TG-1101 (ublituximab) to potentially treat relapsing forms of multiple sclerosis (MS). A special protocol assessment (SPA) is a procedure by which the agency officially evaluates the…

Myobuddy Products has enlisted a rising fitness star to help it publicize its new Myobuddy Massager Pro, a massaging device that can help anyone from an elite athlete to a person with a muscle condition such as multiple sclerosis. Dakota Rager, who qualified for the national Reebok CrossFit Games competition, is a former Army diver who beat out more than 200,000 men in several regional competitions this year. CrossFit is a workout regimen aimed at improving the body's normal functional movements. The Massager Pro takes a multi-pronged massaging approach, including vibration, heat and percussion therapy, or applying tension to the body. The device's benefits including soothing sore muscles and helping relax tight fascia, or connective tissue surrounding muscles. Myobuddy started an MS Support Program in May to encourage MS patients to try massage therapy and to advance research on the approach. The company said some MS patients report that the Massage Pro helps them sleep better by alleviating their restless leg syndrome. They also report that it relieves muscle tension and fatigue, it added. Myobuddy's website includes information on how to use the Massage Pro for any muscle group. Those with questions can get answers by emailing [email protected] or calling (844) 696-2833. Rager (@ragerdakota), who at 5’4’’ and 169 lbs. is built like a fireplug, said he uses everything he can to give him an edge in competitions. If a massage therapy device is powerful enough to help MS patients, then it can help him, too, he has decided. "I really love the Myobuddy Massager, and have been using it throughout my training," he said in a press release. "It has the perfect combination of vibration and power and really goes deep to soothe my sore muscles and relax my tight ones after rigorous workouts. I highly recommend it for anyone who wants their muscles to feel and perform their very best." At only 25, Rager is already ranked as one of the top 100 CrossFit competitors worldwide. He was just one of 40 men to participate in the Reebok CrossFit Games in Madison, Wisconsin, Aug. 3-6. "We've had a lot of highly influential people in the sports and fitness world deliver organic endorsements for the Myobuddy, and we're extremely grateful for that," said Lillo Furca, Myobuddy's founder and CEO. "We've spent so much time and energy perfecting our massager to ensure that it delivers optimal results. The testimonies are a testament to our team and to our product." The company loves to "hear about how we're helping people who put their bodies in extreme situations on a regular basis," he added.

The Consortium of Multiple Sclerosis Centers (CMSC) will form a new Physician Assistant Special Interest Group to provide physician assistants (PAs) with a specialized forum to exchange ideas and information on multiple sclerosis (MS) patient care. CMSC is an educational, training, and networking organization for MS healthcare professionals…

The MyoPro electric arm, which uses motors to help multiple sclerosis patients move weakened arms and hands, has obtained a quality designation required for selling medical equipment in Europe. Myomo‘s powered brace, which also helps people with spinal cord and nerve injuries, received what the European Union calls CE Mark certification. The company…

Accessible housing is not optional for people with disabilities. Poverty and disability too often combine for too many people. It is one thing to know this double whammy exists intellectually. To see the impact in a person packs a visceral punch that cannot be denied. Think of how profoundly…

Abarca Health has signed a value-based reimbursement contract with Biogen for select products in its multiple sclerosis (MS) portfolio. This is the first time such an agreement applies outcomes-based contracts to cover Medicaid patients in the United States. The deal offers a novel approach to connecting outcomes with the…

Five clinics in the Washington area that specialize in administering intravenous and injected treatments to people with chronic diseases are now offering the new multiple sclerosis therapy Ocrevus (ocrelizumab). Arise Infusion Therapy Services said its staff is helping patients manage the authorization process that many insurers require before agreeing to cover…

A group of experts recently concluded that clinical trials are the best way to explore whether cell-based therapies are viable options for treating multiple sclerosis. In a newly published article, MS researchers reviewed evidence on a range of cell therapies, including stem cell transplants and delivery or stimulation of various cell types. Clinical trials, the panel argued, would be the optimal way to examine which types of cells should be used, how they should be delivered, and the types and disease stages the treatments are suitable for. The article focused on four types of cell-based treatments: autologous stem cell transplants, mesenchymal and related stem cell transplants, use of drugs to manipulate stem cells in the body to boost their ability to repair, and transplants of oligodendrocyte progenitor cells to trigger new myelin production. Loss of the myelin that protects neurons is a hallmark of MS. Such treatments hold promise to attain what current disease-modifying therapies in MS have not: halting the disease without lifelong treatment that has potential side effects, and regenerating damaged tissue. In addition to reviewing the evidence surrounding cell-based treatments, the expert group focused on the availability of the treatment options outside of controlled trials. “Media attention has resulted in some cases of misrepresentation and exaggeration of therapeutic claims for cell-based therapies for multiple sclerosis and other diseases,” the team wrote. This has caused patients to seek the treatments — paying out-of-pocket — at unregulated clinics. The panel noted that several drugs in development, including opicinumab, are aimed at promoting remyelination. In addition, drugs that are already approved for other conditions might have remyelinating properties, and might be repurposed to treat MS. Although studies are ongoing, the panel noted that it is unclear if the drugs do promote remyelination. Despite ongoing research and — in some cases — clinical use of cell-based therapies for MS, these treatments should be considered experimental, the expert group concluded. They again underscored the importance of clinical trials in providing a controlled environment for patients wishing to have cell therapy, as well as a source of evidence for the feasibility of these approaches.

A cell therapy intended to boost myelin regeneration — Q-Cells by Q Therapeutics — has received a green light from the U.S. Food and Drug Administration to proceed with a clinical trial in patients with transverse myelitis (TM), a disease that like multiple sclerosis is characterized by myelin damage. FDA approval of the company’s Investigational New…

Christine Sinclair, captain of Canadian women’s soccer teams that won two Olympic bronze medals, has joined the fight against multiple sclerosis by supporting A&W’s Burgers to Beat MS campaign. The Multiple Sclerosis Society of Canada said Sinclair will visit A&W restaurants across Canada on Aug. 23 and 24 to raise funds and awareness of MS. Sinclair is close to the cause because her mother, Sandi, who coached her soccer teams when Christine was a child, has the disease. Sandi is one of about 100,000 people with MS in Canada, which has the highest rate of the disease in the world. "I have become a part of this to educate the public and support finding a cure," Sinclair said in a press release. "I don't want other people to go through what my family has gone through, with the difficulties my mom faces every day." Sandi Sinclair now lives in a long-term care facility. Christine decided to help the MS Society of Canada after her mother's mobility become more and more limited, and she finally ended up in a wheelchair. "Each year we look forward to our partnership with A&W," said Valerie Hussey, chair of the MS Society of Canada's board of directors. "We are excited to have Christine, a Canadian icon, share her personal connection to MS and help raise awareness for our cause." Burgers to Beat MS, now in its ninth year, has raised nearly $10 million for the cause. It is the country's largest annual fundraiser benefiting the MS Society of Canada. From this week on, about 900 A&W restaurants nationwide will be helping the society raise funds. Supporters will be able to donate by rounding up their bill at the register, by buying $1, $2 or $5 paper cutouts, or by dropping cash in donation mugs. Supporters will also be able to contribute online. The campaign will end with a special day on Thursday, Aug. 24, when those who run the restaurants double every donation made from the sale of Teen Burgers. This means the donation on each burger will go from $1 to $2.

Ocrevus' market introduction is off to a stellar start, with nearly half of neurologists surveyed by Spherix Global Insights saying they are using the therapy — the first ever approved for both relapsing and primary progressive multiple sclerosis. Within six months, 80 percent of neurologists are expected to prescribe Ocrevus, according to a report in the second-quarter edition of RealTime Dynamix: Multiple Sclerosis by Spherix Global Insights. But insurance is having an increasing impact on treatment decisions, the report also found, according to a Spherix press release. More patients are receiving less than optimal care because of inadequate or inferior insurance coverage, and neurologists report that insurers have become more aggressive in managing MS patients. Surveying 104 neurologists in June, the report showed that physicians followed through with their intent — reported in earlier surveys — to prescribe Ocrevus as it became available. With Ocrevus being the first approved drug for primary progressive MS, these patients make up a sizable part of those receiving it. But patients with relapsing forms of MS represent more than half of new users, according to the report. Ocrevus was also, by far, the drug that neurologists had learned most about, and felt most excited about using, the report added. Most of the patients on Ocrevus were switched from Biogen's Tysabri or Rituxan — a drug that, like Ocrevus, is also produced by Genentech/Roche. One in five patients was switched from an oral disease-modifying treatment, mainly Biogen’s Tecfidera (dimethyl fumarate). But for about 25 percent of Ocrevus-treated patients, the drug is the first disease-modifying therapy they have received. The survey also revealed that patients are the driving force behind new Ocrevus prescriptions. Seventy-one percent of neurologists receive requests from patients who want to start the treatment. While neurologists have to turn some of these requests down for various reasons, a large proportion of those who ask for the treatment receive it. Another insight from Spherix’s “RealWorld Dynamix: DMT Brand Switching in MS” survey was that patients' requests for a specific brand are often honored. Seventy-seven percent were prescribed the brand they requested, the survey showed. Interestingly, neurologists believed the number to be lower. Most patients who made a specific request, the report indicated, asked for Tecfidera in the past year and a half. Tecfidera is by far the leading oral disease-modifying drug prescribed in MS. Meanwhile, according to the report, Biogen's Avonex, Bayer's Betaseron, Teva's Copaxone, and EMD Serono's Rebif continue on a downward path. At least 30 percent of neurologists report lower use of these therapies in the past three months. Patients previously on these drugs are mainly switched to oral disease-modifying drugs. But this trend is projected to slow, with only Sanofi-Genzyme's oral Aubagio (teriflunomide) continuing to grow. But the choice of treatment may increasingly be driven by insurance. Compared with the same quarter of 2016 — when neurologists estimated that 14 percent of patients received suboptimal treatment because of poor insurance coverage — 20 percent of patients are now judged to be in this situation. Also, 60 percent of surveyed physicians feel that insurance companies have become more aggressive in MS treatment management. A similar percentage also say that insurance policies influence how they prescribe specific disease-modifying drugs.

Australia has become the first country to approve Genentech's Ocrevus for relapsing and primary progressive multiple sclerosis treatment since the therapy's initial approval by the U.S. Food and Drug Administration in March 2017. The Australian Therapeutic Goods Administration gave Ocrevus the green light on July 17, filling an unmet need for Australia's estimated 23,000 MS patients. “We are pleased that another regulatory body recognized for its rigorous review process has approved Ocrevus with a broad label as a new treatment option for people with relapsing or primary progressive MS in Australia,” Dr. Sandra Horning, Roche’s chief medical officer and head of global product cevelopment, said in a press release. “Approval in Australia is significant because of the high prevalence of MS in the country, making it the leading cause of non-traumatic disability in young adults." The drug's developer, Genentech, and Genentech's parent company Roche have submitted applications to get Ocrevus approved in more than 50 countries in Europe, Latin America and the Middle East. Ocrevus trials showed that, among relapsing patients, relapse rates were nearly halved compared to those treated with Rebif. Many of these patients also reached a level of no disease activity — measures that Genentech has continued to explore after the drug's U.S. approval. In addition, data also showed that PPMS patients, who deteriorate more rapidly, benefit from Ocrevus treatment. “People with PPMS [primary progressive multiple sclerosis], who often experience faster and more severe disability, have not had any approved treatment until Ocrevus," Horning said. "We continue to work closely with regulatory authorities across the world to bring Ocrevus to people with multiple sclerosis as soon as possible." Ocrevus is an antibody that blocks the CD20 molecule on certain immune B-cells. Researchers believe these cells directly damage myelin — the protective coat that insulates nerve cells in the brain and spinal cord. Evidence also indicates that B-cells can directly damage neurons themselves. The drug continues to be evaluated in a range of clinical trials, including one that specifically focuses on how the drug’s B-cell depleting actions play out to harness MS disease processes.

A recent patient survey reveals that almost one in four people with multiple sclerosis in the U.K. are not aware of available treatments that could help delay the onset of disability, even though a clear majority put disability as a chief worry. The report, funded by Sanofi Genzyme, was conducted by Adelphi…

My disability rights activism includes housing issues. Affordable housing gets a lot of attention (no solutions, but attention, at least). Accessible housing, not so much. Like the invisible symptoms of multiple sclerosis, the need for affordable ACCESSIBLE housing remains hidden. Accessibility needs to be part of the dialogue I…

The European Medicines Agency has restricted the use of Zinbryta (daclizumab) for relapsing multiple sclerosis after reports of patients experiencing severe liver damage and one dying of liver disease. The temporary order restricts Zinbryta to European Union patients with a highly active disease who have failed to respond to…

B-cells of patients with relapsing-remitting multiple sclerosis (RRMS) secrete substances that are toxic to both neurons and neuron-protecting myelin-forming cells, causing both kinds to die, according to a study. Despite analyses of numerous inflammatory and other factors believed to drive MS processes, researchers were unable to identify the molecules that are toxic, however. Dr. Robert Lisak of Wayne State University in Detroit, Dr. Amit Bar-Or of McGill University in Montreal and their teams are now working on identifying the factor, and learning if the process is also involved in progressive MS. Their study, “B-cells from patients with multiple sclerosis induce cell death via apoptosis in neurons in vitro,” was published in the Journal of Neuroimmunology. It demonstrated that B-cells gathered from the blood of RRMS patients killed lab-grown neurons and oligodendrocyte cells, which form myelin, a protecting coating for nerve cells. Deterioration of the myelin coating and the death of neurons are hallmarks of MS. An earlier study the team conducted indicated that B-cells from MS patients could kill oligodendrocytes. But since the experiments involved only three patients and three controls, the team scaled up their experiments to include 13 patients and an equal number of controls. Both rat and human neurons died when mixed with MS-derived B-cells. In contrast, B-cells from healthy people had little or no impact on the survival of the brain cells. Researchers also discovered that the secreted toxic molecules had no impact on other types of central nervous system cells — astrocytes and microglia. The toxins killed only neurons and myelin-producing cells. The B-cells triggered a process called apoptosis, or programmed cell death, researchers said. This is basically a suicide program. It tells a cell to die when exposed to stressful factors or toxins. The process differs from cell disintegration. Despite thoroughly screening about 40 inflammation-related substances, researchers were unable to identify any factors that caused the cells to die. The National MS Society and the Research Foundation of the MS Society of Canada funded the research, which the U.S. society highlighted in a news release. In the newest phase of the study, researchers will try to learn more about the processes underlying neuron and myelin-related cell deaths and identify the factors responsible. In addition to testing B-cells from progressive MS patients, the team will examine patients with other autoimmune conditions to see if the process is unique to MS or not. Researchers increasingly realize that B-cells are important to MS processes. This observation was underscored by U.S. regulators' approval of the B-cell depleting therapy Ocrevus (ocrelizumab) at treatment for both relapsing and primary progressive MS.

Genentech shared new insights into the workings of Ocrevus (ocrelizumab) and its effectiveness in reducing disease activity and slowing progression in relapsing and primary progressive multiple sclerosis (MS) at the recent 3rd Congress of the European Academy of Neurology (EAN). The new findings, previously reported here, built on analyses of information gathered during the three Phase 3 clinical trials assessing Ocrevus' safety and efficacy, as well as through monitoring patients in extension studies. The studies showed that nearly 40 percent of Ocrevus-treated relapsing patients and nearly 30 percent of primary progressive patients achieved NEPAD during the Phase 3 trials. In contrast, only 21.5 percent of those treated with Rebif and 9.4 percent receiving placebo achieved NEPAD — figures that demonstrate Ocrevus’ impact on patients’ lives, as well as Ocrevus’ ability to slow the decline in walking ability and other types of disabilities are comparable between patients with relapsing and primary progressive disease — data that demonstrate that the treatment acts on disease mechanisms that drive disability in both disease forms. How these effects play out in the long-term is the subject of ongoing research, as Genentech continues to follow these patients in an extension study. In addition, Ocrevus' prescription label strongly advises against pregnancy while on the treatment. Despite precautions, some women became pregnant during the trials. One of the meeting presentations narrated outcomes of these pregnancies; one healthy baby born at term and two ongoing pregnancies in women exposed to the drug. But while Genentech monitors women who become pregnant while on Ocrevus, the number of reported pregnancies is too small to draw conclusions about the treatment’s safety in pregnancy, and researchers do not know if Ocrevus also depletes B-cells in the fetus or in the baby born to a treated woman.

New analyses of how Merck’s Mavenclad (cladribine tablets) act to treat relapsing multiple sclerosis (MS) give researchers an entirely new picture of immune processes leading to the disease. Data showed that the drug lowers both immune B-cells and, to a lesser degree, T-cells. But the numbers of both cell…

The multiple sclerosis therapy Tysabri could trigger melanoma, the Southern Network on Adverse Reactions (SONAR) has warned. Although its investigation failed to demonstrate that melanoma is more common among Tysabri-treated MS patients than in the general population, unusual features among the patients raise concerns about a possible link, the organization said. Contending that current monitoring efforts are inadequate, it suggested improvements that could generate a better understanding of the relationship between Tysabri treatment and cancer. The organization's report, published in the journal Cancer Medicine, was titled “Melanoma complicating treatment with natalizumab for multiple sclerosis: A report from the Southern Network on Adverse Reactions, also known as SONAR." SONAR is an organization that was formed in the Southern United States in 2010 to investigate adverse drug reactions that regulators might not be aware of. Its goal is to reduce the time it takes between detecting an adverse reaction and have regulators act on it. A case that a SONAR investigator came across led to the group investigating possible links between Tysabri and melanoma. A 43-year-old woman developed melanoma in her urethra, the tubing that drains urine from the bladder, after being treated with Tysabri for about two years. Melanoma is most often a skin cancer that is related to sun exposure, but the woman had no skin lesions. After extensive surgery, she relapsed and died when the cancer spread to other parts of her body. She had declined anti-cancer treatment. The case prompt SONAR to look for similar cases. Its investigators found seven studies that involved Tysabri-treated MS patients developing melanoma. In addition, they looked through the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) and the Tysabri Safety Surveillance Program. The surveillance program is part of the Tysabri Outcomes Unified Commitment to Health (TOUCH) database run by Tysabri's developer, Biogen, The research team found 137 cases in the FAERS database through April 1, 2014. The patients' average age was 45. Seventeen percent of the group developed tumors in locations not exposed to the sun, and nine died. The researchers said the database contained only about half the information it should have, such as tumor site, patients' family history of cancer, and earlier immunosuppressive treatment. Fifteen percent of the cases in the FAERS database were based entirely on information from the TOUCH database. Seventy-three percent were cases initially reported to FAERS but with TOUCH information added. Thirteen percent of the FAERS cases contained no additional information. Importantly, there was even less patient information in the TOUCH database than in the FAERS database. Out of eight items researchers believe a database should contain, TOUCH had information on two, on average. “The existence of the TOUCH Safety Surveillance Program, an FDA-mandated program, did not improve melanoma reporting,” the team wrote. This shortage of data stymies research into possible links between Tysabri treatment and melanoma, the researchers said. As an example, although the death rates in the databases were low, there was no information about survival in many cases, which could lead to flawed survival estimates. The investigation noted that patients received a wide range of Tysabri doses before they were diagnosed with melanoma. While some received only one or a few injections, others had been treated for a long time. These observations do not seem to support a link between Tysabri and melanoma, the team said. “A longer therapy duration would be expected if natalizumab caused melanoma via an immunologic pathway, unless existing nevi [lesions of the skin or mucus tissue] were already premalignant lesions,” the researchers wrote. But other information the team found seemed to suggest a Tysabri-melanoma link. For example, the average age of melanoma patients was much lower than that reported in the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) database. The average age in the institute's database is 63, compared with 45 in the FAERS database and 41 in cases in academic journals. In addition, many patients developed tumors in unusual places not exposed to sunlight. Finally, the low melanoma death rate in Tysabri-treated patients differed from that seen in the general population. All these factors suggest that melanoma after Tysabri treatment could differ from other types of melanoma, the researchers argued. While the molecular workings of Tysabri might promote melanoma growth, studies so far have not found a relationship between the drug and this cancer. In fact, some studies suggest that MS patients, in general, have a lower risk of melanoma than others. The team said more information on patients could give researchers a better understanding of the potential relationship between Tysabri and melanoma. The implication was that the standard of reporting in the FAERS and TOUCH databases could improve. To minimize the risk of patients who receive Tysabri developing melanoma, the researchers offered a number of suggestions for IV centers, physicians, patients, and educational programs. For instance, they suggested that all patients should have a skin examination before the start of treatment, and regular physical and skin exams while receiving Tysabri. While noting that risk of infection and the development of tumors can occur with all immunosuppressive treatments, the team said more studies are needed to explore the risk of Tysabri-treated patients developing melanoma.